Overview

This trial is active, not recruiting.

Condition chronic myeloid leukemia
Treatments bosutinib, imatinib
Phase phase 3
Target BCR-ABL
Sponsor Pfizer
Collaborator Wyeth is now a wholly owned subsidiary of Pfizer
Start date February 2008
End date August 2010
Trial size 502 participants
Trial identifier NCT00574873, 3160A4-3000, B1871008

Summary

Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Bosutinib
bosutinib SKI 606
500 mg once daily, by mouth (tablet) with food preferably in the morning. Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.
(Active Comparator)
Imatinib
imatinib Gleevec
400 mg once daily, by mouth (tablet). Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.

Primary Outcomes

Measure
Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1
time frame: Year 1

Secondary Outcomes

Measure
Percentage of Participants With Major Molecular Response (MMR) at Year 1
time frame: Year 1
Duration of Complete Cytogenetic Response (CCyR)
time frame: Every 12 weeks in Year 1, every 24 weeks in Years 2 and 3 and every 48 weeks for Year 4 through 5
Duration of Complete Hematologic Response (CHR)
time frame: Every 4 weeks up to Week 20 thereafter every 12 weeks until 7 to 28 days after last dose of study medication
Duration of Major Molecular Response (MMR)
time frame: Every 12 weeks for Years 1 and 2 and every 24 weeks for Year 3 through 5
Population Pharmacokinetics
time frame: 0 hours (pre-dose) on Day 1, 28, 56 and 84 and 3, 6 hours post-dose on Day 1 and 28
Time to Transformation to Accelerated Phase (AP) or Blast Phase (BP)
time frame: From date of randomization (Week 0) up to first confirmed transformation to AP/BP phase or 7 to 28 days after last dose of study medication

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed less than 6 months. - Diagnosis of CML chronic phase confirmed. - Adequate hepatic and renal function. - Able to take oral tablets. Exclusion Criteria: - Exclusions include Philadelphia negative CML. - Prior anti-leukemia treatment. - Prior stem cell transplant.

Additional Information

Official title A Phase 3 Randomized, Open-Label Study Of Bosutinib Versus Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Pfizer.