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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00098657




Registration number
NCT00098657
Ethics application status
Date submitted
3/06/2004
Date registered
4/06/2004
Date last updated
26/01/2010

Titles & IDs
Public title
SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Scientific title
A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Secondary ID [1] 0 0
A6181034
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell 0 0
Chronic Myelogenous Leukemia 0 0
Myeloid Leukemia, Chronic, Accelerated Phase 0 0
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive 0 0
Leukemia, Myeloid, Chronic Phase 0 0
Leukemia, Lymphoblastic, Acute, Philadelphia-positive 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Blood 0 0 0 0
Other blood disorders
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Interferon-alfa
Treatment: Drugs - SU011248
Treatment: Drugs - Dasatinib
Treatment: Drugs - Dasatinib
Treatment: Drugs - Temsirolimus (CCI-779)
Treatment: Drugs - Temsirolimus (CCI-779)
Treatment: Drugs - Imatinib mesylate
Treatment: Drugs - dasatinib
Treatment: Drugs - Investigator's choice
Treatment: Drugs - dasatinib
Treatment: Drugs - Dasatinib
Treatment: Drugs - Dasatinib

Active comparator: 2 -

Experimental: 1 -

Experimental: 1 -

Experimental: 1 -

Experimental: A -

Experimental: B -

Active comparator: C -

Experimental: dasatinib Twice a Day (BID) - 70 mg dasatinib twice a day (BID)

Experimental: Imatinib 400 mg - Oral dose of 400mg Imatinib once daily. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.

Experimental: dasatinib Once a Day (QD) - 140 mg dasatinib once a day (QD)

Experimental: imatinib 800 mg - Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Experimental: 1 -


Treatment: Drugs: Interferon-alfa
3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity

Treatment: Drugs: SU011248
50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity

Treatment: Drugs: Dasatinib
Tablets, Oral, 70 mg, twice daily, until disease progression or intolerable toxicity, switch to the roll-over study or study closure

Treatment: Drugs: Dasatinib
Tablets, Oral, 70 mg, twice daily, Until disease progression or intolerable toxicity, switch to the roll-over study or study closure.

Treatment: Drugs: Temsirolimus (CCI-779)
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week

Treatment: Drugs: Temsirolimus (CCI-779)
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week

Treatment: Drugs: Imatinib mesylate
Imatinib is packaged in bottles as 100mg and 400mg tablets

Treatment: Drugs: dasatinib
Tablets, Oral, 70 mg BID, indefinitely, survival study

Treatment: Drugs: Investigator's choice
Any of the following single agent treatments:

1. Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecutive days, every 28 days or oral administration, as appropriate.
2. Chlorambucil 0.1 (0.1-0.2) mg/kg PO daily for 3 to 6 weeks as required OR 0.4 (0.3 0.8) mg/kg PO every 21 to 28 days
3. Gemcitabine 1 gm/m2 IV over 30 minutes on days 1, 8 and 15 every 28 days or day 1 and day 8 every 21 days
4. Cyclophosphamide 300 (200-450) mg/m2 PO daily for 5 consecutive days every 21 to 28 days, OR 600 (400-1200) mg/m2 IV every 21 to 28 days
5. Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response,
6. Etoposide 50 (50-150) mg/m2 IV daily for 3-5 days every 21 to 28 days OR 100 (50 300) mg/m2 PO daily for 3-5 days every 21 to 28 days
7. Prednisone 40 (20-60) mg/m2 PO daily or every other day
8. Dexamethasone 20(20-40) mg PO/IV daily for 5 consecutive days, every 14 - 28 day

Treatment: Drugs: dasatinib
Tablets, Oral, 140 mg QD, indefinitely, survival study

Treatment: Drugs: Dasatinib
Tablets; oral; 70 mg BID, depending on response

Treatment: Drugs: Dasatinib
Tablets, Oral, 70 mg, twice daily, Until disease progression or untolerable toxicity, switch to the roll-over study or study closure
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS), Core Radiology Assessment
Timepoint [1] 0 0
Day 28 of each 6-week cycle: duration of treatment phase
Primary outcome [2] 0 0
Progression-Free Survival (PFS), Investigator's Assessment
Timepoint [2] 0 0
Day 28 of each 6-week cycle: duration of treatment phase
Primary outcome [3] 0 0
Major and Overall Hematologic Response (MaHR and OHR)
Timepoint [3] 0 0
Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment
Primary outcome [4] 0 0
Major and Overall Hematologic Response (MaHR and OHR)
Timepoint [4] 0 0
Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment
Primary outcome [5] 0 0
Progression-Free Survival (PFS)
Timepoint [5] 0 0
Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
Primary outcome [6] 0 0
Percentage of Participants With Major Molecular Response (MMR) Rates at 12 Months
Timepoint [6] 0 0
12 months
Primary outcome [7] 0 0
Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population
Timepoint [7] 0 0
Randomization up to 6 months
Primary outcome [8] 0 0
Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)
Timepoint [8] 0 0
2 years
Primary outcome [9] 0 0
Major and overall hematologic response rates
Timepoint [9] 0 0
throughout the study
Secondary outcome [1] 0 0
Objective Response, Core Radiology Assessment
Timepoint [1] 0 0
Day 28 of each 6-week cycle: duration of treatment phase
Secondary outcome [2] 0 0
Objective Response, Investigator's Assessment
Timepoint [2] 0 0
Day 28 of each 6-week cycle: duration of treatment phase
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Clinic visit or telephone contact every 2 months until death
Secondary outcome [4] 0 0
Time to Tumor Progression (TTP), Core Radiology Assessment
Timepoint [4] 0 0
Randomization to first documentation of tumor progression: duration of treatment phase
Secondary outcome [5] 0 0
Time to Tumor Progression (TTP), Investigator's Assessment
Timepoint [5] 0 0
Randomization to first documentation of tumor progression: duration of treatment phase
Secondary outcome [6] 0 0
Duration of Response (DR), Core Radiology Assessement
Timepoint [6] 0 0
Day 28 of each cycle: duraton of treatment phase
Secondary outcome [7] 0 0
Duration of Response (DR), Investigator's Assessment
Timepoint [7] 0 0
Day 28 of each cycle: duration of treatment phase
Secondary outcome [8] 0 0
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale
Timepoint [8] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [9] 0 0
FACT-Kidney Symptom Index (FKSI) Subscale
Timepoint [9] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [10] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G)
Timepoint [10] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [11] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale
Timepoint [11] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [12] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale
Timepoint [12] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [13] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale
Timepoint [13] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [14] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale
Timepoint [14] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [15] 0 0
EuroQoL Five Dimension (EQ-5D) Health State Index
Timepoint [15] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [16] 0 0
Euro-QoL Visual Analog Scale (EQ-VAS)
Timepoint [16] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [17] 0 0
Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis
Timepoint [17] 0 0
Day 1 & Day 28, Cycle 1 to Cycle 4
Secondary outcome [18] 0 0
Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis
Timepoint [18] 0 0
Day 1 & Day 28, Cycle 1 to Cycle 4
Secondary outcome [19] 0 0
Incremental Cost Effectiveness Ratio (ICER)
Timepoint [19] 0 0
post study measurement
Secondary outcome [20] 0 0
Ctrough Concentrations of SU011248
Timepoint [20] 0 0
Day 28 of Cycle 1 to Cycle 4
Secondary outcome [21] 0 0
Ctrough Concentrations of Metabolite SU012662
Timepoint [21] 0 0
Day 28 of Cycle 1 to Cycle 4
Secondary outcome [22] 0 0
Ctrough Concentrations of SU011248 and Active Metabolite SU012662
Timepoint [22] 0 0
Day 28 of Cycle 1 to Cycle 4
Secondary outcome [23] 0 0
Percentage of Participants Who Achieved MaHR and Did Not Progress at 12 Months (Based on the Kaplan-Meier Estimate of the Duration of Response)
Timepoint [23] 0 0
12 months
Secondary outcome [24] 0 0
Percentage of Participants Who Achieved MaHR and Did Not Progress at 24 Months in the Imatinib-Resistant Group (Based on the Kaplan-Meier Estimate of the Duration of Response)
Timepoint [24] 0 0
24 months
Secondary outcome [25] 0 0
Percentage of Participants Who Achieved OHR and Did Not Progress at 12 Months and 24 Months
Timepoint [25] 0 0
12 months, 24 months
Secondary outcome [26] 0 0
Median Time in Days From First Dosing Date to Date of MaHR
Timepoint [26] 0 0
Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment
Secondary outcome [27] 0 0
Time to OHR
Timepoint [27] 0 0
Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment
Secondary outcome [28] 0 0
Best Cytogenetic Response
Timepoint [28] 0 0
Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment
Secondary outcome [29] 0 0
Best Confirmed Hematologic Response
Timepoint [29] 0 0
Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment
Secondary outcome [30] 0 0
Number of Participants Who Achieved a Major Molecular Response (MMR) During Treatment Period
Timepoint [30] 0 0
Baseline, every 12 weeks throughout study (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).
Secondary outcome [31] 0 0
MaHR and MCyR Among Participants With Baseline BCR-ABL Point Mutations
Timepoint [31] 0 0
Baseline, at time of disease progression. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).
Secondary outcome [32] 0 0
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)
Timepoint [32] 0 0
Baseline, every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up.(treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).
Secondary outcome [33] 0 0
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Hematologic Toxicities, and Toxicities Leading to Discontinuation
Timepoint [33] 0 0
Continuous from pretreatment through each 4-week cycle and at follow-up. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).
Secondary outcome [34] 0 0
Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)
Timepoint [34] 0 0
Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
Secondary outcome [35] 0 0
Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 Hours (AUC[0-T])
Timepoint [35] 0 0
Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
Secondary outcome [36] 0 0
Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)
Timepoint [36] 0 0
Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
Secondary outcome [37] 0 0
Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)
Timepoint [37] 0 0
Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
Secondary outcome [38] 0 0
Population PK of Dasatinib
Timepoint [38] 0 0
Day 8 immediately prior to the first daily dose and between 30 minutes to 3 hours following this dose.
Secondary outcome [39] 0 0
Median Duration of Major Hematologic Response (MaHR)
Timepoint [39] 0 0
Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment
Secondary outcome [40] 0 0
Median Duration of Overall Hematologic Response (OHR)
Timepoint [40] 0 0
Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment
Secondary outcome [41] 0 0
Time to MaHR and OHR
Timepoint [41] 0 0
Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment
Secondary outcome [42] 0 0
Number of Participants With Complete, Partial, Minor, Minimal, or No Cytogenetic Response
Timepoint [42] 0 0
Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment
Secondary outcome [43] 0 0
Number of Participants With CHR or NEL, MiHR, or no Hematologic Response
Timepoint [43] 0 0
Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycles 1 and 2; After every 2nd cycle for Cycles 3+; at end of treatment
Secondary outcome [44] 0 0
Number of Participants Achieving Major Molecular Response (MMR)
Timepoint [44] 0 0
Baseline, every 12 weeks, and at time of Complete Cytogenetic Response (CCyR) for quantitative Polyermase Chain Reaction (qPCR) analysis
Secondary outcome [45] 0 0
MaHR and Major Cytogenetic Response (MCyR) Among Participants With Baseline BCR-ABL Point Mutations
Timepoint [45] 0 0
baseline, at time of disease progression
Secondary outcome [46] 0 0
Minimally Significant Changes From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)
Timepoint [46] 0 0
Baseline, Every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up
Secondary outcome [47] 0 0
Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), AEs Leading to Discontinuation, Drug-Related AEs
Timepoint [47] 0 0
Continuously throughout study, from pre-treatment visit through end of study (due to death, unacceptable toxicity, treatment failure, etc) and follow-up period
Secondary outcome [48] 0 0
Pharmacokinetics (PK) of Dasatinib - Maximum Observed Plasma Concentration (Cmax)
Timepoint [48] 0 0
Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
Secondary outcome [49] 0 0
Pharmacokinetics (PK) of Dasatinib - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h or 24 h(AUC[0-T])
Timepoint [49] 0 0
Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
Secondary outcome [50] 0 0
Pharmacokinetics (PK) of Dasatinib - Time to Maximum Observed Plasma Concentration (Tmax)
Timepoint [50] 0 0
Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
Secondary outcome [51] 0 0
Pharmacokinetics (PK) of Dasatinib - Plasma Half-life (T-HALF)
Timepoint [51] 0 0
Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
Secondary outcome [52] 0 0
Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)
Timepoint [52] 0 0
Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
Secondary outcome [53] 0 0
Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h (AUC[0-T])
Timepoint [53] 0 0
Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
Secondary outcome [54] 0 0
Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)
Timepoint [54] 0 0
Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
Secondary outcome [55] 0 0
Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)
Timepoint [55] 0 0
Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.
Secondary outcome [56] 0 0
Population PK of Dasatinib
Timepoint [56] 0 0
Day 8 immediately prior to the first daily dose and between 30 minutes to 3 hours following this dose.
Secondary outcome [57] 0 0
Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months
Timepoint [57] 0 0
24, 36 and 42 months
Secondary outcome [58] 0 0
Percentage of Participants With Objective Response
Timepoint [58] 0 0
Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
Secondary outcome [59] 0 0
Percentage of Participants With Complete Cytogenetic Response (CCyR) Rate at 12, 24, 36, 42 Months
Timepoint [59] 0 0
12, 24, 36, 42 months
Secondary outcome [60] 0 0
Percentage of Participants With Complete Hematological Response (CHR) Rates at 12, 24, 36, and 42 Months
Timepoint [60] 0 0
12, 24, 36, and 42 months
Secondary outcome [61] 0 0
Percentage of Patients With Undetectable Levels of Bcr-Abl (A Fusion Gene of the Breakpoint Cluster Region [Bcr] Gene and Abelson Proto-oncogene [Abl] Genes) Transcripts
Timepoint [61] 0 0
12 , 24, 36 and 42 months
Secondary outcome [62] 0 0
Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population
Timepoint [62] 0 0
Randomization up to 2 years
Secondary outcome [63] 0 0
Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population
Timepoint [63] 0 0
Randomization up to 2 years
Secondary outcome [64] 0 0
Median Time to Major Hematologic Response (MaHR) - Randomized Population
Timepoint [64] 0 0
Day 1 up to 6 months (time of primary endpoint), 2 years
Secondary outcome [65] 0 0
Time to First Major Molecular Response
Timepoint [65] 0 0
42 months overall
Secondary outcome [66] 0 0
Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study
Timepoint [66] 0 0
Day 1 up to 5 years
Secondary outcome [67] 0 0
Time to First Complete Cytogenetic Response
Timepoint [67] 0 0
60 months overall
Secondary outcome [68] 0 0
Time to First Complete Hematological Response (CHR)]
Timepoint [68] 0 0
60 months overall
Secondary outcome [69] 0 0
Percent of Participants With Overall Hematologic Response - Randomized Population
Timepoint [69] 0 0
Randomization up to 6 Months, 2 Years
Secondary outcome [70] 0 0
Estimated Rate of Event Free Survival (EFS) in Two Treatment Arms
Timepoint [70] 0 0
60 months over all
Secondary outcome [71] 0 0
Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population
Timepoint [71] 0 0
Randomization up to 6 months, 2 years
Secondary outcome [72] 0 0
Estimated Rate of Progression Free Survival (PFS) in Two Treatment Arms
Timepoint [72] 0 0
60 months over all and follow up period
Secondary outcome [73] 0 0
Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population
Timepoint [73] 0 0
Randomization up to 6 Months, 2 Years
Secondary outcome [74] 0 0
Estimated Rate of Progression to Accelerated Phase (AC)/Blast Crisis (BC) in Two Treatment Arms
Timepoint [74] 0 0
60 months over all and follow up period
Secondary outcome [75] 0 0
Number of Participants With Best Cytogenic Response (CyR) - Randomized Population
Timepoint [75] 0 0
Randomization up to 6 Months, 2 Years
Secondary outcome [76] 0 0
Median Progression Free Survival (PFS) - Randomized Population
Timepoint [76] 0 0
Randomization up to 5 Years
Secondary outcome [77] 0 0
Estimated Rate of Overall Survival (OS) in Two Treatment Arms
Timepoint [77] 0 0
60 months over all and follow up period
Secondary outcome [78] 0 0
Kaplan-Meier Estimates of Duration of First Major Molecular Response Until Confirmed Loss
Timepoint [78] 0 0
From First major molecular response to first confirmed loss or censoring
Secondary outcome [79] 0 0
Median Overall Survival (OS) - Randomized Population
Timepoint [79] 0 0
Randomization up to 5 Years
Secondary outcome [80] 0 0
Kaplan-Meier Estimates of Duration of First Complete Cytogenetic Response (CCyR)
Timepoint [80] 0 0
From first complete cytogenetic response to first confirmed loss or censoring
Secondary outcome [81] 0 0
Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population
Timepoint [81] 0 0
24 months, 36 months, 48 months, 60 months
Secondary outcome [82] 0 0
Mean Actual Dose Intensity Per Day
Timepoint [82] 0 0
start of treatment to Month 36
Secondary outcome [83] 0 0
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants
Timepoint [83] 0 0
Day 1 to Year 7
Secondary outcome [84] 0 0
Number of Participants With Normal Baseline Versus Worst Grade 3/4 Hematology Laboratory Abnormalities up to Year 2 in Treated Participants
Timepoint [84] 0 0
Baseline to Year 2
Secondary outcome [85] 0 0
Imatinib Pharmacokinetic Trough Plasma Concentration (Cmin) at Month 12
Timepoint [85] 0 0
Month 12
Secondary outcome [86] 0 0
Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations
Timepoint [86] 0 0
Day 1 up to Year 7
Secondary outcome [87] 0 0
Estimated Rates of Progression Free Survival (PFS) on Treatment by Major Molecular Response (MMR)
Timepoint [87] 0 0
42 months
Secondary outcome [88] 0 0
Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants
Timepoint [88] 0 0
Baseline to Year 2
Secondary outcome [89] 0 0
Time to First Complete Molecular Response (CMR)]
Timepoint [89] 0 0
48 months overall
Secondary outcome [90] 0 0
Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants
Timepoint [90] 0 0
Baseline to Year 2
Secondary outcome [91] 0 0
Number of Participants With the Effect of Imatinib on the Diabetic Participants With Known Concomitant Type II Diabetes
Timepoint [91] 0 0
12 months
Secondary outcome [92] 0 0
Number of Participants With Maximal QTcF Intervals up to Year 2 in Treated Participants
Timepoint [92] 0 0
Baseline up to Year 2
Secondary outcome [93] 0 0
Number of Imatinib-intolerant Participants With MCyR
Timepoint [93] 0 0
Baseline to 2 years
Secondary outcome [94] 0 0
Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months
Timepoint [94] 0 0
12 and 24 Months
Secondary outcome [95] 0 0
Median Time From First Dosing Date to Date of MCyR
Timepoint [95] 0 0
Baseline (within 4 weeks of Day 1) and every 12 weeks
Secondary outcome [96] 0 0
Durability of hematologic response and time to hematologic response (major and overall)
Timepoint [96] 0 0
throughout the study
Secondary outcome [97] 0 0
Number of Participants With Complete Hematologic Response (CHR)
Timepoint [97] 0 0
Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study
Secondary outcome [98] 0 0
Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months
Timepoint [98] 0 0
12 and 24 months
Secondary outcome [99] 0 0
Assess cytogenetic and molecular responses
Timepoint [99] 0 0
throughout the study
Secondary outcome [100] 0 0
Measure minor hematologic response rate in the imatinib resistant group
Timepoint [100] 0 0
throughout the study
Secondary outcome [101] 0 0
Explore the role of BCR-ABL mRNA expression and point mutations in the BCR-ABL gene
Timepoint [101] 0 0
throughout the study
Secondary outcome [102] 0 0
Median Time From First Dosing Until CHR
Timepoint [102] 0 0
Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study
Secondary outcome [103] 0 0
Measure the heath-related QOL using FACT-G
Timepoint [103] 0 0
throughout the study
Secondary outcome [104] 0 0
Number of Participants With Major Molecular Response (MMR)
Timepoint [104] 0 0
Baseline to 2 years
Secondary outcome [105] 0 0
To assess safety and tolerability of dasatinib
Timepoint [105] 0 0
throughout the study
Secondary outcome [106] 0 0
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Timepoint [106] 0 0
Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria.
Secondary outcome [107] 0 0
Population PK
Timepoint [107] 0 0
first month
Secondary outcome [108] 0 0
Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE
Timepoint [108] 0 0
Continuously, from baseline through 2 years
Secondary outcome [109] 0 0
Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE
Timepoint [109] 0 0
Continuously, from baseline through 2 years
Secondary outcome [110] 0 0
Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib
Timepoint [110] 0 0
Day 8 of study; pretreatment through sample between 30 minutes and 3 hours following treatment, a sample between 5 hours and 8 hours following treatment and a sample at 12 hours, prior to the next dose.

Eligibility
Key inclusion criteria
* Histologically confirmed renal cell carcinoma of clear cell histology with metastases
* Evidence of measurable disease by radiographic technique
* Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
* History of or known brain metastases
* Serious acute or chronic illness or recent history of significant cardiac abnormality

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
Accrual to date
Final
750
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Lismore
Recruitment hospital [2] 0 0
Pfizer Investigational Site - St. Leonards
Recruitment hospital [3] 0 0
Pfizer Investigational Site - South Brisbane
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Woodville South
Recruitment hospital [5] 0 0
Pfizer Investigational Site - East Melbourne
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Perth
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Victoria
Recruitment hospital [8] 0 0
Local Institution - St. Leonards
Recruitment hospital [9] 0 0
Local Institution - South Brisbane
Recruitment hospital [10] 0 0
Local Institution - East Melbourne
Recruitment hospital [11] 0 0
Local Institution - Parkville
Recruitment hospital [12] 0 0
Local Institution - Wien
Recruitment hospital [13] 0 0
Local Institution - Adelaide
Recruitment hospital [14] 0 0
Local Institution - St Leonards
Recruitment hospital [15] 0 0
Local Institution - Perth
Recruitment hospital [16] 0 0
Novartis Investigative Site - St. Leonards
Recruitment hospital [17] 0 0
Novartis Investigative Site - Waratah
Recruitment hospital [18] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [19] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [20] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [21] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [22] 0 0
Novartis Investigative Site - East Melbourne
Recruitment hospital [23] 0 0
Novartis Investigative Site - Fitzroy
Recruitment hospital [24] 0 0
Novartis Investigative Site - Frankston
Recruitment hospital [25] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [26] 0 0
Novartis Investigative Site - Prahran
Recruitment hospital [27] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [28] 0 0
Local Institution - East Mebourne
Recruitment postcode(s) [1] 0 0
2480 - Lismore
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment postcode(s) [7] 0 0
36184 - Victoria
Recruitment postcode(s) [8] 0 0
- St. Leonards
Recruitment postcode(s) [9] 0 0
- South Brisbane
Recruitment postcode(s) [10] 0 0
- East Melbourne
Recruitment postcode(s) [11] 0 0
- Parkville
Recruitment postcode(s) [12] 0 0
- Wien
Recruitment postcode(s) [13] 0 0
- Adelaide
Recruitment postcode(s) [14] 0 0
3000 - East Melbourne
Recruitment postcode(s) [15] 0 0
2065 - St Leonards
Recruitment postcode(s) [16] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [17] 0 0
3050 - Parkville
Recruitment postcode(s) [18] 0 0
WA 6000 - Perth
Recruitment postcode(s) [19] 0 0
- Waratah
Recruitment postcode(s) [20] 0 0
- Westmead
Recruitment postcode(s) [21] 0 0
- Herston
Recruitment postcode(s) [22] 0 0
- Woolloongabba
Recruitment postcode(s) [23] 0 0
- Fitzroy
Recruitment postcode(s) [24] 0 0
- Frankston
Recruitment postcode(s) [25] 0 0
- Prahran
Recruitment postcode(s) [26] 0 0
- East Mebourne
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arkansas
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
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Florida
Country [6] 0 0
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Illinois
Country [7] 0 0
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Kansas
Country [8] 0 0
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Kentucky
Country [9] 0 0
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Louisiana
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State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
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Michigan
Country [13] 0 0
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Minnesota
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Mississippi
Country [15] 0 0
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Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New Hampshire
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
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Ohio
Country [20] 0 0
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Oklahoma
Country [21] 0 0
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
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Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
Wisconsin
Country [28] 0 0
Brazil
State/province [28] 0 0
RJ
Country [29] 0 0
Brazil
State/province [29] 0 0
RS
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
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Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
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Quebec
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Cedex 15
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Lyon
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Rennes
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Essen
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Ulm
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Modena
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Roma
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Lodz
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Poznan
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State/province [55] 0 0
Kaluga Region
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Russian Federation
State/province [56] 0 0
Chelyabinsk
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Moscow
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Saint-Petersburg
Country [59] 0 0
Russian Federation
State/province [59] 0 0
St. Petersburg
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Tomsk
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
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Spain
State/province [62] 0 0
Navarra
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Spain
State/province [64] 0 0
Sevilla
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Cardiff
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United Kingdom
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Lancashire
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Middlesex
Country [68] 0 0
United Kingdom
State/province [68] 0 0
London
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Sutton Surrey
Country [70] 0 0
United States of America
State/province [70] 0 0
Alabama
Country [71] 0 0
United States of America
State/province [71] 0 0
Georgia
Country [72] 0 0
United States of America
State/province [72] 0 0
New Jersey
Country [73] 0 0
Argentina
State/province [73] 0 0
Buenos Aires
Country [74] 0 0
Argentina
State/province [74] 0 0
Cordoba
Country [75] 0 0
Belgium
State/province [75] 0 0
B-Leuven
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Belgium
State/province [76] 0 0
Edegem
Country [77] 0 0
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State/province [77] 0 0
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Country [78] 0 0
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State/province [78] 0 0
Rio De Janeiro
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Brazil
State/province [79] 0 0
Sao Paulo
Country [80] 0 0
Denmark
State/province [80] 0 0
Aarhus
Country [81] 0 0
Finland
State/province [81] 0 0
Helsinki
Country [82] 0 0
France
State/province [82] 0 0
LIlle
Country [83] 0 0
France
State/province [83] 0 0
Lyon Cedex 03
Country [84] 0 0
France
State/province [84] 0 0
Nantes
Country [85] 0 0
France
State/province [85] 0 0
Paris
Country [86] 0 0
France
State/province [86] 0 0
Pessac
Country [87] 0 0
France
State/province [87] 0 0
Poitiers Cedex
Country [88] 0 0
France
State/province [88] 0 0
Strasbourg Cedex
Country [89] 0 0
Germany
State/province [89] 0 0
Hamburg
Country [90] 0 0
Germany
State/province [90] 0 0
Mainz
Country [91] 0 0
Germany
State/province [91] 0 0
Mannheim
Country [92] 0 0
Israel
State/province [92] 0 0
Ramat-Gan
Country [93] 0 0
Italy
State/province [93] 0 0
Bologna
Country [94] 0 0
Italy
State/province [94] 0 0
Orbassano
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Jeollanam-Do
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Kyunggi-Do
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Seoul
Country [98] 0 0
Netherlands
State/province [98] 0 0
Nijmegen
Country [99] 0 0
Netherlands
State/province [99] 0 0
Rotterdam
Country [100] 0 0
Norway
State/province [100] 0 0
Trondheim
Country [101] 0 0
Peru
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Lima
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Quezon City
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Singapore
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Sweden
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Lund
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Sweden
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Umea
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Sweden
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Uppsala
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Switzerland
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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United Kingdom
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Central
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United Kingdom
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Greater London
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Austria
State/province [114] 0 0
Wien
Country [115] 0 0
France
State/province [115] 0 0
Lille
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France
State/province [116] 0 0
Paris Cedex 10
Country [117] 0 0
United States of America
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District of Columbia
Country [118] 0 0
United States of America
State/province [118] 0 0
Hawaii
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Belgium
State/province [119] 0 0
Brugge
Country [120] 0 0
Belgium
State/province [120] 0 0
Gent
Country [121] 0 0
Belgium
State/province [121] 0 0
Leuven
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United States of America
State/province [122] 0 0
Indiana
Country [123] 0 0
Brazil
State/province [123] 0 0
Porto Alegre - RS
Country [124] 0 0
United States of America
State/province [124] 0 0
Iowa
Country [125] 0 0
Chile
State/province [125] 0 0
Santiago
Country [126] 0 0
United States of America
State/province [126] 0 0
North Carolina
Country [127] 0 0
China
State/province [127] 0 0
Beijing
Country [128] 0 0
China
State/province [128] 0 0
Shanghai
Country [129] 0 0
France
State/province [129] 0 0
Paris Cedex 15
Country [130] 0 0
United States of America
State/province [130] 0 0
New Mexico
Country [131] 0 0
France
State/province [131] 0 0
Pierre Benite
Country [132] 0 0
France
State/province [132] 0 0
Strasbourg
Country [133] 0 0
France
State/province [133] 0 0
Villejuif Cedex
Country [134] 0 0
Germany
State/province [134] 0 0
BW
Country [135] 0 0
Germany
State/province [135] 0 0
Heidelberg
Country [136] 0 0
Belgium
State/province [136] 0 0
B-leuven
Country [137] 0 0
Belgium
State/province [137] 0 0
Bruxelles
Country [138] 0 0
Italy
State/province [138] 0 0
Catania
Country [139] 0 0
Belgium
State/province [139] 0 0
Charleroi
Country [140] 0 0
Italy
State/province [140] 0 0
Milano
Country [141] 0 0
Belgium
State/province [141] 0 0
Yvoir
Country [142] 0 0
United States of America
State/province [142] 0 0
South Carolina
Country [143] 0 0
Brazil
State/province [143] 0 0
Parana
Country [144] 0 0
United States of America
State/province [144] 0 0
Virginia
Country [145] 0 0
Czech Republic
State/province [145] 0 0
Brno
Country [146] 0 0
Czech Republic
State/province [146] 0 0
Prague 2
Country [147] 0 0
Argentina
State/province [147] 0 0
La Plata
Country [148] 0 0
Switzerland
State/province [148] 0 0
Aarau
Country [149] 0 0
Denmark
State/province [149] 0 0
Aarhus C
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Devon
Country [151] 0 0
Denmark
State/province [151] 0 0
Herlev
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Hants
Country [153] 0 0
Denmark
State/province [153] 0 0
Odense C
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Surrey
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France
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Caen Cedex
Country [156] 0 0
France
State/province [156] 0 0
Creteil Cedex
Country [157] 0 0
France
State/province [157] 0 0
Grenoble Cedex 9
Country [158] 0 0
France
State/province [158] 0 0
Lille Cedex
Country [159] 0 0
France
State/province [159] 0 0
Lyon Cedex
Country [160] 0 0
France
State/province [160] 0 0
Marseille Cedex 9
Country [161] 0 0
Canada
State/province [161] 0 0
Calgary
Country [162] 0 0
Canada
State/province [162] 0 0
Montreal
Country [163] 0 0
Germany
State/province [163] 0 0
Dresden
Country [164] 0 0
Canada
State/province [164] 0 0
Ottawa
Country [165] 0 0
Germany
State/province [165] 0 0
Frankfurt
Country [166] 0 0
Italy
State/province [166] 0 0
Firenze
Country [167] 0 0
Germany
State/province [167] 0 0
Leipzig
Country [168] 0 0
Greece
State/province [168] 0 0
Athens
Country [169] 0 0
Hungary
State/province [169] 0 0
Budapest
Country [170] 0 0
Ireland
State/province [170] 0 0
Dublin
Country [171] 0 0
Israel
State/province [171] 0 0
Ramat-gan
Country [172] 0 0
Italy
State/province [172] 0 0
Bari
Country [173] 0 0
Italy
State/province [173] 0 0
Monza
Country [174] 0 0
Italy
State/province [174] 0 0
Orbassano (to)
Country [175] 0 0
Korea, Republic of
State/province [175] 0 0
Jeollanam-do
Country [176] 0 0
Poland
State/province [176] 0 0
Katowice
Country [177] 0 0
Poland
State/province [177] 0 0
Warsaw
Country [178] 0 0
Russian Federation
State/province [178] 0 0
St.petersburg
Country [179] 0 0
South Africa
State/province [179] 0 0
Free State
Country [180] 0 0
South Africa
State/province [180] 0 0
Gauteng
Country [181] 0 0
South Africa
State/province [181] 0 0
Western Cape
Country [182] 0 0
Spain
State/province [182] 0 0
Valencia
Country [183] 0 0
Sweden
State/province [183] 0 0
Stockholm
Country [184] 0 0
Germany
State/province [184] 0 0
Frankfurt/Main
Country [185] 0 0
Austria
State/province [185] 0 0
Wein
Country [186] 0 0
United Kingdom
State/province [186] 0 0
Scotland
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Tyne And Wear
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Edinburgh
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Liverpool
Country [190] 0 0
Ireland
State/province [190] 0 0
Galway

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).
Trial website
https://clinicaltrials.gov/study/NCT00098657
Trial related presentations / publications
Rini BI, Hutson TE, Figlin RA, Lechuga MJ, Valota O, Serfass L, Rosbrook B, Motzer RJ. Sunitinib in Patients With Metastatic Renal Cell Carcinoma: Clinical Outcome According to International Metastatic Renal Cell Carcinoma Database Consortium Risk Group. Clin Genitourin Cancer. 2018 Aug;16(4):298-304. doi: 10.1016/j.clgc.2018.04.005. Epub 2018 May 4.
de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
Cella D, Michaelson MD, Bushmakin AG, Cappelleri JC, Charbonneau C, Kim ST, Li JZ, Motzer RJ. Health-related quality of life in patients with metastatic renal cell carcinoma treated with sunitinib vs interferon-alpha in a phase III trial: final results and geographical analysis. Br J Cancer. 2010 Feb 16;102(4):658-64. doi: 10.1038/sj.bjc.6605552. Epub 2010 Jan 26.
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00098657