NCT00261846

Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias

A Phase 1/2 Study Of Bosutinib (Ski-606) In Philadelphia Chromosome Positive Leukemias

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 571 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Bosutinib	Part 1, starting dose 400 mg oral, daily dosing in the dose-escalation component. Part 2, 500 mg oral, continuous, daily dosing.

Timeline

• Start date: 2006-01-18
• Primary completion: 2009-09-25
• Completion: 2015-08-06
• First posted: 2005-12-05
• Last updated: 2017-07-27
• Results posted: 2013-03-12

Locations

111 sites across 27 countries: United States, Argentina, 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