CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 571 enrolled
Drug / intervention
Bosutinibdrug
Likely dose
Bosutinib 400 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/NCT00261846
NCT00261846Phase 2Completed
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A Phase 1/2 Study Of Bosutinib (Ski-606) In Philadelphia Chromosome Positive Leukemias

Pfizer·interventional·Posted Dec 5, 2005·Updated Jul 27, 2017

In Brief

A Phase 2 clinical trial evaluating Bosutinib for Chronic Myeloid Leukemia. Completed, enrolled 571 participants across 111 sites in 27 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myeloid Leukemia
CountriesArgentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Finland, Germany, Hong Kong, Hungary, India, Italy, Mexico, Netherlands, Norway, Peru, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 5, 2005
Enrollment StartJan 18, 2006
Primary CompletionSep 25, 2009
Study CompletionAug 6, 2015
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 20.6 years ago

Interventions

Bosutinibdrug

Part 1, starting dose 400 mg oral, daily dosing in the dose-escalation component. Part 2, 500 mg oral, continuous, daily dosing.