Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00261846




Registration number
NCT00261846
Ethics application status
Date submitted
2/12/2005
Date registered
5/12/2005
Date last updated
27/07/2017

Titles & IDs
Public title
Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias
Scientific title
A Phase 1/2 Study Of Bosutinib (Ski-606) In Philadelphia Chromosome Positive Leukemias
Secondary ID [1] 0 0
B1871006, 3160A4-200-WW
Secondary ID [2] 0 0
3160A4-200
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukemia 0 0
Condition category
Condition code
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
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 - Bosutinib

Experimental: SKI-606 -


Treatment: Drugs: Bosutinib
Part 1, starting dose 400 mg oral, daily dosing in the dose-escalation component.

Part 2, 500 mg oral, continuous, daily dosing.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Dose Limiting Toxicity (DLT)
Timepoint [1] 0 0
Part 1 Baseline up to Day 28
Primary outcome [2] 0 0
Maximum Tolerated Dose (MTD)
Timepoint [2] 0 0
Part 1 Baseline up to Day 28
Primary outcome [3] 0 0
Maximum Observed Plasma Concentration (Cmax) - Part 1
Timepoint [3] 0 0
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1
Primary outcome [4] 0 0
Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1
Timepoint [4] 0 0
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1
Primary outcome [5] 0 0
Plasma Decay Half-Life (t1/2) - Part 1
Timepoint [5] 0 0
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1
Primary outcome [6] 0 0
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC(0-48)] - Part 1
Timepoint [6] 0 0
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1
Primary outcome [7] 0 0
Area Under the Concentration-Time Curve (AUC) - Part 1
Timepoint [7] 0 0
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1
Primary outcome [8] 0 0
Apparent Oral Clearance (CL/F) - Part 1
Timepoint [8] 0 0
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1
Primary outcome [9] 0 0
Apparent Volume of Distribution (Vz/F) - Part 1
Timepoint [9] 0 0
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1
Primary outcome [10] 0 0
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) - Part 1
Timepoint [10] 0 0
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15
Primary outcome [11] 0 0
Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) - Part 1
Timepoint [11] 0 0
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15
Primary outcome [12] 0 0
Plasma Decay Half-Life at Steady State (t1/2,ss) - Part 1
Timepoint [12] 0 0
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15
Primary outcome [13] 0 0
Area Under the Concentration-Time Curve at Steady State (AUCss) - Part 1
Timepoint [13] 0 0
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15
Primary outcome [14] 0 0
Apparent Oral Clearance at Steady State (CL/F,ss) - Part 1
Timepoint [14] 0 0
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15
Primary outcome [15] 0 0
Accumulation Ratio (R)
Timepoint [15] 0 0
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 1 and Day 15
Primary outcome [16] 0 0
Percentage of Participants With MCyR at Week 24 in Chronic Phase Second-line Imatinib Resistant CML Population - Part 2
Timepoint [16] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants With Major Cytogenetic Response (MCyR) - Part 1
Timepoint [1] 0 0
Weeks 12, 24, 36, 48 and the end of active treatment phase of Part 1 (Week 52)
Secondary outcome [2] 0 0
Phosphorylation Inhibition of Breakpoint Cluster Region-Abelson Kinase (Bcr-Abl) - Part 1
Timepoint [2] 0 0
Baseline, Weeks 4, 8, 12, 24, 36, 48 and the end of the active treatment phase of Part 1 (Week 52)
Secondary outcome [3] 0 0
Phosphorylation Inhibition of Crk Like (CrkL) Protein at Baseline - Part 1
Timepoint [3] 0 0
0 (pre-dose) on Day 1 (Baseline)
Secondary outcome [4] 0 0
Percent Change From Baseline in Phosphorylation Inhibition of Crk Like Protein (CrkL) at Day 1, 8 and 15 - Part 1
Timepoint [4] 0 0
6 hours post-dose on Day 1, 0 (pre-dose), 6 hours post-dose on Day 8, 15
Secondary outcome [5] 0 0
Percentage of Participants With Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Chronic Phase Third-line CML Population - Part 2
Timepoint [5] 0 0
Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L) or Year 5 (CP2L)
Secondary outcome [6] 0 0
Kaplan-Meier Estimate of Retaining an Attained/Maintained Major Cytogenetic Response (MCyR) at Year 5 in Chronic Phase Second-line CML - Part 2
Timepoint [6] 0 0
From first MCyR to loss of MCyR or censoring, assessed every 12 weeks up to 2 years and then every 24 weeks thereafter up to Year 5
Secondary outcome [7] 0 0
Time to Achieve Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML for Responders Only - Part 2
Timepoint [7] 0 0
Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 5
Secondary outcome [8] 0 0
Kaplan-Meier Estimate of Maintaining Complete Hematologic Response (CHR) at Year 4 (CP3L and ADV) or Year 5 (CP2L) - Part 2
Timepoint [8] 0 0
From date of first confirmed CHR to loss of CHR or censoring, assessed at Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)
Secondary outcome [9] 0 0
Duration of Complete Hematologic Response (CHR) - Part 2
Timepoint [9] 0 0
From date of first confirmed CHR to loss of CHR or censoring, assessed at Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)
Secondary outcome [10] 0 0
Time to Achieve Complete Hematologic Response (CHR) for Responders Only - Part 2
Timepoint [10] 0 0
Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)
Secondary outcome [11] 0 0
Cumulative Incidence of Progression/Death - Part 2
Timepoint [11] 0 0
Years 1, 2, 3, 4, and 5 (CP2L only)
Secondary outcome [12] 0 0
Progression Free Survival (PFS) - Part 2
Timepoint [12] 0 0
Years 1, 2, 3, 4, and 5 (CP2L only)
Secondary outcome [13] 0 0
Kaplan-Meier Estimate of Overall Survival (OS) - Part 2
Timepoint [13] 0 0
Years 1, 2, 3, 4, and 5 (CP2L only)
Secondary outcome [14] 0 0
Overall Survival (OS) - Part 2
Timepoint [14] 0 0
Years 1, 2, 3, 4, and 5 (CP2L only)
Secondary outcome [15] 0 0
Percentage of Participants With Confirmed Complete Hematologic Response (CHR) - Part 2
Timepoint [15] 0 0
Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)
Secondary outcome [16] 0 0
Percentage of Participants With Overall Hematologic Response (OHR) by Week 48 in Advanced Leukemia Population - Part 2
Timepoint [16] 0 0
Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 1 year
Secondary outcome [17] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Timepoint [17] 0 0
Baseline up to follow up visit (30 days after last dose of study treatment)
Secondary outcome [18] 0 0
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Timepoint [18] 0 0
Baseline up to follow-up visit (30 days after last dose of study treatment)
Secondary outcome [19] 0 0
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Timepoint [19] 0 0
Week 1, 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter
Secondary outcome [20] 0 0
Percentage of Participants With On-treatment PCI Change From Baseline in Electrocardiogram (ECG) Findings
Timepoint [20] 0 0
Baseline, 0 (pre-dose), 2, 4, 6 hours on Day 1, 0 (pre-dose), 2, 4, 6, 20-23 hours on Day 21, and end of treatment visit
Secondary outcome [21] 0 0
Number of Participants With Change From Baseline in Findings of Chest X-ray
Timepoint [21] 0 0
Baseline, Week 8, and end of treatment
Secondary outcome [22] 0 0
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Timepoint [22] 0 0
Baseline and Weeks 1, 2, 3, 4, 8, 12, then every 12 weeks thereafter until end of treatment, for a mean duration of 28 months
Secondary outcome [23] 0 0
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Timepoint [23] 0 0
Baseline, Week 1, 2, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter
Secondary outcome [24] 0 0
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs
Timepoint [24] 0 0
Screening, Baseline, and end of treatment
Secondary outcome [25] 0 0
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs and Number of Participants With PCI Values
Timepoint [25] 0 0
Post-therapy

Eligibility
Key inclusion criteria
* Ph+ CML or Ph+ ALL who are primarily refractory to full-dose imatinib (600 mg), have disease progression/relapse while on full-dose imatinib, or are intolerant of any dose of imatinib.
* At least 3 months post stem cell transplantation
* Able to take daily oral capsules/tablets reliably
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with Philadelphia chromosome, and bcr-abl negative CML
* Overt leptomeningeal leukemia
* Subjects without evidence of leukemia in bone marrow (extramedullary disease only)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
18/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/08/2015
Sample size
Target
Accrual to date
Final
571
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Institute of Medical and Veterinary Science - Adelaide
Recruitment hospital [3] 0 0
Department of Clinical Haematology and Bone Marrow Transplantation - Melbourne
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Queensland
Recruitment hospital [5] 0 0
Haematology and Oncology Clinics of Australia - Queensland
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3181 - Melbourne
Recruitment postcode(s) [4] 0 0
4029 - Queensland
Recruitment postcode(s) [5] 0 0
4101 - Queensland
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Argentina
State/province [13] 0 0
Provincia de Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Ciudad Autonoma de Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Corrientes
Country [17] 0 0
Argentina
State/province [17] 0 0
Pcia de Buenos Aires
Country [18] 0 0
Austria
State/province [18] 0 0
Wels
Country [19] 0 0
Brazil
State/province [19] 0 0
Sao Paulo/sp - Brazil
Country [20] 0 0
Brazil
State/province [20] 0 0
Sp - Brazil
Country [21] 0 0
Brazil
State/province [21] 0 0
Sp Brazil
Country [22] 0 0
Brazil
State/province [22] 0 0
Curitiba, PR
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Manitoba
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
Chile
State/province [28] 0 0
Temuco
Country [29] 0 0
China
State/province [29] 0 0
P.r China
Country [30] 0 0
China
State/province [30] 0 0
P.r. China
Country [31] 0 0
China
State/province [31] 0 0
Shanghai
Country [32] 0 0
Colombia
State/province [32] 0 0
Antioquia
Country [33] 0 0
Colombia
State/province [33] 0 0
Cundinamarca
Country [34] 0 0
Finland
State/province [34] 0 0
Helsinki
Country [35] 0 0
Germany
State/province [35] 0 0
RP
Country [36] 0 0
Germany
State/province [36] 0 0
Dresden
Country [37] 0 0
Germany
State/province [37] 0 0
Hamburg
Country [38] 0 0
Germany
State/province [38] 0 0
Magdeburg
Country [39] 0 0
Germany
State/province [39] 0 0
Mainz
Country [40] 0 0
Germany
State/province [40] 0 0
Mannheim
Country [41] 0 0
Hong Kong
State/province [41] 0 0
Chai Wan
Country [42] 0 0
Hong Kong
State/province [42] 0 0
Hong Kong
Country [43] 0 0
Hungary
State/province [43] 0 0
Budapest
Country [44] 0 0
India
State/province [44] 0 0
Tamil Nadu
Country [45] 0 0
Italy
State/province [45] 0 0
Province of Bologna
Country [46] 0 0
Italy
State/province [46] 0 0
Torino
Country [47] 0 0
Italy
State/province [47] 0 0
Bologna
Country [48] 0 0
Italy
State/province [48] 0 0
Monza
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Seoul
Country [50] 0 0
Mexico
State/province [50] 0 0
Nuevo Leon
Country [51] 0 0
Mexico
State/province [51] 0 0
Toluca Estado de Mexico
Country [52] 0 0
Netherlands
State/province [52] 0 0
Amsterdam
Country [53] 0 0
Netherlands
State/province [53] 0 0
Groningen
Country [54] 0 0
Netherlands
State/province [54] 0 0
The Netherlands
Country [55] 0 0
Norway
State/province [55] 0 0
Norge
Country [56] 0 0
Peru
State/province [56] 0 0
Lima
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Ekaterinburg
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Kirov
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Moscow
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Rostov-on Don
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Saint Petersburg
Country [62] 0 0
Singapore
State/province [62] 0 0
Singapore
Country [63] 0 0
South Africa
State/province [63] 0 0
Bloemfontein
Country [64] 0 0
South Africa
State/province [64] 0 0
Cape Town
Country [65] 0 0
South Africa
State/province [65] 0 0
Parktown
Country [66] 0 0
South Africa
State/province [66] 0 0
Soweto
Country [67] 0 0
Spain
State/province [67] 0 0
Catalonia
Country [68] 0 0
Spain
State/province [68] 0 0
Madrid
Country [69] 0 0
Spain
State/province [69] 0 0
Valencia
Country [70] 0 0
Sweden
State/province [70] 0 0
Uppsala
Country [71] 0 0
Taiwan
State/province [71] 0 0
Taipei 100
Country [72] 0 0
United Kingdom
State/province [72] 0 0
North East England
Country [73] 0 0
United Kingdom
State/province [73] 0 0
London
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Newcastle Upon Tyne, North East England

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

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, continuous daily dosing, two-part safety and efficacy study of SKI-606 (bosutinib) in Philadelphia chromosome positive leukemias (Ph+). Part 1 is a dose-escalation study in chronic phase Chronic Myelogenous Leukemia (CML) subjects to establish the maximum tolerated dose (MTD) in this subject population. Part 2 has begun after the completion of Part 1 and after a dose has been established for the compound in chronic phase subjects. Part 2 is a study of the the efficacy of 500mg daily oral SKI-606 (bosutinib) in patients with all phases of Ph+ CML and Ph+ Acute Lymphocytic Leukemia (ALL). The protocol will test the hypotheses that oral daily dosing of bosutinib at 500 mg will attain (1) Major Cytogenetic Response (MCyR) in chronic phase CML patients and (2) Overall Hematological Response (OHR) in advanced leukemia patients. Each phase of the disease will be evaluated as a separate cohort.
Trial website
https://clinicaltrials.gov/study/NCT00261846
Trial related presentations / publications
Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.
Kota V, Brummendorf TH, Gambacorti-Passerini C, Lipton JH, Kim DW, An F, Leip E, Crescenzo RJ, Ferdinand R, Cortes JE. Efficacy and safety following bosutinib dose reduction in patients with Philadelphia chromosome-positive leukemias. Leuk Res. 2021 Dec;111:106690. doi: 10.1016/j.leukres.2021.106690. Epub 2021 Aug 21.
Gambacorti-Passerini C, Cortes JE, Lipton JH, Kantarjian HM, Kim DW, Schafhausen P, Crescenzo R, Bardy-Bouxin N, Shapiro M, Noonan K, Leip E, DeAnnuntis L, Brummendorf TH, Khoury HJ. Safety and efficacy of second-line bosutinib for chronic phase chronic myeloid leukemia over a five-year period: final results of a phase I/II study. Haematologica. 2018 Aug;103(8):1298-1307. doi: 10.3324/haematol.2017.171249. Epub 2018 May 17.
Kantarjian HM, Mamolo CM, Gambacorti-Passerini C, Cortes JE, Brummendorf TH, Su Y, Reisman AL, Shapiro M, Lipton JH. Long-term patient-reported outcomes from an open-label safety and efficacy study of bosutinib in Philadelphia chromosome-positive chronic myeloid leukemia patients resistant or intolerant to prior therapy. Cancer. 2018 Feb 1;124(3):587-595. doi: 10.1002/cncr.31082. Epub 2017 Oct 26.
Cortes JE, Khoury HJ, Kantarjian HM, Lipton JH, Kim DW, Schafhausen P, Matczak E, Leip E, Noonan K, Brummendorf TH, Gambacorti-Passerini C. Long-term bosutinib for chronic phase chronic myeloid leukemia after failure of imatinib plus dasatinib and/or nilotinib. Am J Hematol. 2016 Dec;91(12):1206-1214. doi: 10.1002/ajh.24536. Epub 2016 Sep 15.
Whiteley J, Reisman A, Shapiro M, Cortes J, Cella D. Health-related quality of life during bosutinib (SKI-606) therapy in patients with advanced chronic myeloid leukemia after imatinib failure. Curr Med Res Opin. 2016 Aug;32(8):1325-34. doi: 10.1185/03007995.2016.1174108. Epub 2016 May 5.
Hsyu PH, Mould DR, Abbas R, Amantea M. Population pharmacokinetic and pharmacodynamic analysis of bosutinib. Drug Metab Pharmacokinet. 2014;29(6):441-8. doi: 10.2133/dmpk.DMPK-13-RG-126. Epub 2014 Jun 10.
Gambacorti-Passerini C, Brummendorf TH, Kim DW, Turkina AG, Masszi T, Assouline S, Durrant S, Kantarjian HM, Khoury HJ, Zaritskey A, Shen ZX, Jin J, Vellenga E, Pasquini R, Mathews V, Cervantes F, Besson N, Turnbull K, Leip E, Kelly V, Cortes JE. Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: Minimum 24-month follow-up. Am J Hematol. 2014 Jul;89(7):732-42. doi: 10.1002/ajh.23728. Epub 2014 Apr 28.
Kantarjian HM, Cortes JE, Kim DW, Khoury HJ, Brummendorf TH, Porkka K, Martinelli G, Durrant S, Leip E, Kelly V, Turnbull K, Besson N, Gambacorti-Passerini C. Bosutinib safety and management of toxicity in leukemia patients with resistance or intolerance to imatinib and other tyrosine kinase inhibitors. Blood. 2014 Feb 27;123(9):1309-18. doi: 10.1182/blood-2013-07-513937. Epub 2013 Dec 17. Erratum In: Blood. 2014 Aug 7;124(6):981.
Trask PC, Cella D, Powell C, Reisman A, Whiteley J, Kelly V. Health-related quality of life in chronic myeloid leukemia. Leuk Res. 2013 Jan;37(1):9-13. doi: 10.1016/j.leukres.2012.09.013. Epub 2012 Oct 29.
Khoury HJ, Cortes JE, Kantarjian HM, Gambacorti-Passerini C, Baccarani M, Kim DW, Zaritskey A, Countouriotis A, Besson N, Leip E, Kelly V, Brummendorf TH. Bosutinib is active in chronic phase chronic myeloid leukemia after imatinib and dasatinib and/or nilotinib therapy failure. Blood. 2012 Apr 12;119(15):3403-12. doi: 10.1182/blood-2011-11-390120. Epub 2012 Feb 27.
Trask PC, Cella D, Besson N, Kelly V, Masszi T, Kim DW. Health-related quality of life of bosutinib (SKI-606) in imatinib-resistant or imatinib-intolerant chronic phase chronic myeloid leukemia. Leuk Res. 2012 Apr;36(4):438-42. doi: 10.1016/j.leukres.2011.10.011. Epub 2011 Oct 28.
Cortes JE, Kantarjian HM, Brummendorf TH, Kim DW, Turkina AG, Shen ZX, Pasquini R, Khoury HJ, Arkin S, Volkert A, Besson N, Abbas R, Wang J, Leip E, Gambacorti-Passerini C. Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome-positive chronic myeloid leukemia patients with resistance or intolerance to imatinib. Blood. 2011 Oct 27;118(17):4567-76. doi: 10.1182/blood-2011-05-355594. Epub 2011 Aug 24. Erratum In: Blood. 2013 Oct 3;122(14):2524.
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/NCT00261846