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

Pfizer

Status and phase

Completed

Phase 2

Conditions

Chronic Myeloid Leukemia

Treatments

Drug: Bosutinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00261846

B1871006, 3160A4-200-WW

B1871006 (Other Identifier)

2005-004230-40 (EudraCT Number)

3160A4-200

Details and patient eligibility

About

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.

Enrollment

571 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.
At least 3 months post stem cell transplantation
Able to take daily oral capsules/tablets reliably

Exclusion criteria

Subjects with Philadelphia chromosome, and bcr-abl negative CML
Overt leptomeningeal leukemia
Subjects without evidence of leukemia in bone marrow (extramedullary disease only)