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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00338884




Registration number
NCT00338884
Ethics application status
Date submitted
16/06/2006
Date registered
20/06/2006
Date last updated
31/08/2012

Titles & IDs
Public title
Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
Scientific title
A Phase II Efficacy And Safety Study Of Sunitinib Malate (SU011248) Administered In A Continuous Daily Regimen In Patients With Advanced (First-Line) Renal Cell Cancer
Secondary ID [1] 0 0
A6181110
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sunitinib malate

Experimental: SUNITINIB MALATE. - Sunitinib malate starting dose 37.5 mg daily continuous daily schedule


Treatment: Drugs: Sunitinib malate
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Overall Confirmed Objective Response (OR)
Timepoint [1] 0 0
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
Secondary outcome [1] 0 0
Duration of Response (DR)
Timepoint [1] 0 0
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause
Secondary outcome [2] 0 0
Time to Tumor Progression (TTP)
Timepoint [2] 0 0
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
Secondary outcome [3] 0 0
Progression-Free Survival (PFS)
Timepoint [3] 0 0
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death
Secondary outcome [4] 0 0
1-Year Survival
Timepoint [4] 0 0
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year
Secondary outcome [5] 0 0
Trough Plasma Concentrations (Ctrough) of Sunitinib
Timepoint [5] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [6] 0 0
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib
Timepoint [6] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [7] 0 0
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib
Timepoint [7] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [8] 0 0
Ctrough of SU-012662 (Sunitinib's Metabolite)
Timepoint [8] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [9] 0 0
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)
Timepoint [9] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [10] 0 0
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)
Timepoint [10] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [11] 0 0
Ctrough of Total Drug (Sunitinib + SU-012662)
Timepoint [11] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [12] 0 0
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)
Timepoint [12] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [13] 0 0
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)
Timepoint [13] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [14] 0 0
Ctrough Correlated With Serious Adverse Events (SAEs)
Timepoint [14] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [15] 0 0
Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline
Timepoint [15] 0 0
Baseline
Secondary outcome [16] 0 0
VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)
Timepoint [16] 0 0
Baseline (Cycle 1, Day 1)
Secondary outcome [17] 0 0
VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Timepoint [17] 0 0
Baseline (Cycle 1, Day 1)
Secondary outcome [18] 0 0
VEGF Ratio to Baseline at Each Time Point
Timepoint [18] 0 0
Baseline to Day 1 of Weeks 3 through 53
Secondary outcome [19] 0 0
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
Timepoint [19] 0 0
Baseline to Day 1 of Weeks 3 through 53
Secondary outcome [20] 0 0
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Timepoint [20] 0 0
Baseline to Day 1 of Weeks 3 through 53
Secondary outcome [21] 0 0
Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
Timepoint [21] 0 0
Baseline
Secondary outcome [22] 0 0
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)
Timepoint [22] 0 0
Baseline (Cycle 1, Day 1)
Secondary outcome [23] 0 0
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Timepoint [23] 0 0
Baseline (Cycle 1, Day 1)
Secondary outcome [24] 0 0
sVEGFR2 Ratio to Baseline at Each Time Point
Timepoint [24] 0 0
Baseline to Day 1 of Weeks 3 through 53
Secondary outcome [25] 0 0
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
Timepoint [25] 0 0
Baseline to Day 1 of Weeks 3 through 53
Secondary outcome [26] 0 0
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Timepoint [26] 0 0
Baseline to Day 1 of Weeks 3 through 53
Secondary outcome [27] 0 0
Patient-Assessed Fatigue
Timepoint [27] 0 0
Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)
Secondary outcome [28] 0 0
Cancer Related Symptoms, Well-Being, and Concerns
Timepoint [28] 0 0
Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)

Eligibility
Key inclusion criteria
* Advanced kidney cancer
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous treatment for kidney cancer, except surgical removal of kidney tumor

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
Single group
Other design features
Phase
Phase 2
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
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Clayton
Recruitment hospital [3] 0 0
Pfizer Investigational Site - East Bentleigh
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3165 - East Bentleigh
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Santa Fé
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Cordoba
Country [4] 0 0
Brazil
State/province [4] 0 0
RS
Country [5] 0 0
Brazil
State/province [5] 0 0
SP
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul
Country [7] 0 0
Mexico
State/province [7] 0 0
Jalisco
Country [8] 0 0
Mexico
State/province [8] 0 0
Nuevo Leon
Country [9] 0 0
Taiwan
State/province [9] 0 0
Taichung
Country [10] 0 0
Taiwan
State/province [10] 0 0
Tainan
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taipei

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

Ethics approval
Ethics application status

Summary
Brief summary
A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.
Trial website
https://clinicaltrials.gov/study/NCT00338884
Trial related presentations / publications
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.
Barrios CH, Hernandez-Barajas D, Brown MP, Lee SH, Fein L, Liu JH, Hariharan S, Martell BA, Yuan J, Bello A, Wang Z, Mundayat R, Rha SY. Phase II trial of continuous once-daily dosing of sunitinib as first-line treatment in patients with metastatic renal cell carcinoma. Cancer. 2012 Mar 1;118(5):1252-9. doi: 10.1002/cncr.26440. Epub 2011 Sep 6.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00338884