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

Completed · Phase 2

Conditions studied: Chronic Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT00261846

Run by

Pfizer

People needed

571

Starts

2006-01-18

Expected to finish

2015-08-06

Last updated by the study team

2017-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• HealthONE Presbyterian — Denver, Colorado, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Emory Clinic — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• Oncology Specialists, S.C. — Niles, Illinois, United States
• Indiana Blood and Marrow Transplantation — Indianapolis, Indiana, United States
• LSU Health Sciences Center — Shreveport, Louisiana, United States
• University Of Maryland Medical Center — Baltimore, Maryland, United States
• University Of Maryland — Baltimore, Maryland, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Hudson Valley Hematology and Oncology Associates — Hawthorne, New York, United States
• Westchester Oncology Hematology Group, P.C. — Hawthorne, New York, United States
• Westchester Oncology Hematology, Group, P.C. — Hawthorne, New York, United States
• New York Presbyterian Hospital — New York, New York, United States
• New York Presbyterian Hospital — New York, New York, United States
• University of Rochester Cancer Center Pharmacy — Rochester, New York, United States
• University of Rochester Medical Center Strong Memorial Hospital - James P. Wilmot Cancer Center — Rochester, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• University of Rochester-James P. Wilmot Cancer Center — Rochester, New York, United States
• University of Rochester — Rochester, New York, United States
• Westchester Medical Center — Valhalla, New York, United States
• Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
• City of Hope National Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.