CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
SKI-606 (Bosutinib)drug
Likely dose
SKI-606 (Bosutinib) 100 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/NCT00811070
NCT00811070Phase 2Completed
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A Phase 1/2 Study Of SKI-606 Administered As A Single Agent In Japanese Subjects With Philadelphia Chromosome Positive Leukemias

Pfizer·interventional·Posted Dec 18, 2008·Updated Jun 28, 2016

In Brief

A Phase 2 clinical trial evaluating SKI-606 (Bosutinib) for Chronic Myelogenous Leukemia. Completed, enrolled 63 participants across 23 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myelogenous Leukemia
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 18, 2008
Enrollment StartDec 1, 2007
Primary CompletionMar 1, 2013
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 17.5 years ago

Interventions

SKI-606 (Bosutinib)drug

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.