Health Condition 1: null- Leukemia, Myeloid, Philadelphia Positive
Conditions
Interventions
Intervention1: Bosutinib (SKI-606): Part 1, starting dose 400 mg oral, daily dosing in the dose-escalation component.
Part 2, 500 mg oral, continuous, daily dosing.
Control Intervention1: Not applica
Sponsors
Wyeth Research Wyeth Pharmaceuticals India Private Limited A Subsidiary of Pfizer Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ph+ CML or Ph+ ALL who are primarily refractory to full-dose imatinib (600 mg), have disease progression/relapse while on full-dose imatinib, or are intolerant of any dose of imatinib. 2. At least 3 months post stem cell transplantation 3. Able to take daily oral capsules/tablets reliably Please note: there is no upper age limit for inclusion criteria for this trial
Exclusion criteria
Exclusion criteria: 1. Subjects with Philadelphia chromosome, and bcr-abl negative CML 2. Overt leptomeningeal leukemia 3. Subjects without evidence of leukemia in bone marrow (extramedullary disease only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Define the maximum tolerated dose (MTD), less than or equal to 1000 mg/day, in patients with chronic myelogenous leukemia (CML) in chronic phase resistant or refractory to imatinibTimepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Assess the safety of SKI-606 (bosutinib) during prolonged oral exposure in a leukemic populationTimepoint: Day 1 to Treatment Failure | — |
Countries
Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Finland, Germany, Hong Kong, Hungary, India, Italy, Mexico, Netherlands, Peru, Republic of Korea, Russian Federation, Singapore, South Africa, Spain, Sweden, Taiwan, United Kingdom, United States of America
Contacts
Public ContactDr Murtuza Bughediwala
Representing Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.)
Outcome results
None listed