NCT00811070

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

A Phase 1/2 Study Of SKI-606 Administered As A Single Agent In Japanese Subjects With Philadelphia Chromosome Positive Leukemias

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a two-part safety and efficacy study of SKI-606 in subjects who have Philadelphia chromosome positive leukemias (CML). Part 1 will be a dose-escalation study, in which an escalating dose of SKI-606 (Bosutinib), up to 600 mg, will be studied in subjects with imatinib resistant/refractory or imatinib intolerant chronic phase CML. Part 2 will evaluate the safety and efficacy of the maximum tolerated dose (MTD) of SKI-606 (Bosutinib)identified in Part 1 of the study.

Conditions

• Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	SKI-606 (Bosutinib)	Formulation: 100 mg Capsule for Part 1, 100 mg tablet for Part1 and Part 2. SKI-606 (Bosutinib) will be taken by mouth with water and food as continuous once-daily dosing.

Timeline

• Start date: 2007-12-01
• Primary completion: 2013-03-01
• Completion: 2015-06-01
• First posted: 2008-12-18
• Last updated: 2016-06-28
• Results posted: 2014-06-04

Locations

23 sites across 1 country: Japan