CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 502 enrolled
Drug / intervention
Bosutinib +1 moredrug
Likely dose
Bosutinib 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00574873
NCT00574873Phase 3Completed
CompareCT.gov

A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN SUBJECTS WITH NEWLY DIAGNOSED CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKEMIA

Pfizer·interventional·Posted Dec 17, 2007·Updated Jan 8, 2019

In Brief

A Phase 3 clinical trial evaluating Bosutinib and imatinib for Chronic Myeloid Leukemia. Completed, enrolled 502 participants across 165 sites in 29 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myeloid Leukemia
CountriesArgentina, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Latvia, Lithuania, Mexico, Poland, Russia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsWyeth is now a wholly owned subsidiary of Pfizer

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 17, 2007
Enrollment StartFeb 5, 2008
Primary CompletionAug 31, 2010
Study CompletionMay 27, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.5 years ago

Interventions

Bosutinibdrug

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.

imatinibdrug

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.