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Study Evaluating SKI-606 (Bos...

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

Last Updated: 2017-07-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

571 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-18

Study Completion Date

2015-08-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Myeloid Leukemia

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SKI-606

Group Type EXPERIMENTAL

Bosutinib

Intervention Type DRUG

Part 1, starting dose 400 mg oral, daily dosing in the dose-escalation component.

Part 2, 500 mg oral, continuous, daily dosing.

Interventions

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Bosutinib

Part 1, starting dose 400 mg oral, daily dosing in the dose-escalation component.

Part 2, 500 mg oral, continuous, daily dosing.

Intervention Type DRUG

Other Intervention Names

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SKI-606

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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City of Hope National Medical Center

Duarte, California, United States

Site Status

HealthONE Presbyterian

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Site Status

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Emory Clinic

Atlanta, Georgia, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Oncology Specialists, S.C.

Niles, Illinois, United States

Site Status

Indiana Blood and Marrow Transplantation

Indianapolis, Indiana, United States

Site Status

LSU Health Sciences Center

Shreveport, Louisiana, United States

Site Status

University Of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

University Of Maryland

Baltimore, Maryland, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Hudson Valley Hematology and Oncology Associates

Hawthorne, New York, United States

Site Status

Westchester Oncology Hematology Group, P.C.

Hawthorne, New York, United States

Site Status

Westchester Oncology Hematology, Group, P.C.

Hawthorne, New York, United States

Site Status

New York Presbyterian Hospital

New York, New York, United States

Site Status