Study Evaluating SKI-606 in Philadelphia Chromosome Positive Leukemias - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00261846

Purpose

This is an open-labeled, continuous daily dosing, two-part safety and efficacy study of SKI-606 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 clear MTD has been established for the compound in chronic phase subjects. Part 2 will include patients in all phases of Ph+ CML and Ph+ Acute Lymphocytic Leukemia (ALL). The protocol will test the hypotheses that oral daily dosing of SKI-606 at the MTD, or a lower dose will attain; (1) Major Cytogenetic Response (McyR) in chronic phase patients and (2) a return to chronic phase in advanced leukemia patients. Each phase of the disease will be evaluated as a separate cohort.

Condition	Intervention	Phase
Leukemia, Myeloid, Chronic	Drug: SKI-606	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1/2 Study of SKI-606 in Philadelphia Chromosome Positive Leukemias

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Bosutinib

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Efficacy; Pharmacokinetics [ Time Frame: Timeframe not specified ] [ Designated as safety issue: No ]

Estimated Enrollment:	459
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SKI-606: Experimental	Drug: SKI-606

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261846

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Show 110 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3160A4-200
Study First Received:	December 2, 2005
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00261846 History of Changes
Health Authority:	Canada: Health Canada; Germany: Ethics Commission; Italy: Ethics Committee; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Spain: Ministry of Health; United States: Food and Drug Administration

Keywords provided by Wyeth:

Leukemia

Additional relevant MeSH terms:

Philadelphia Chromosome
Leukemia
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Hematologic Diseases

Myeloproliferative Disorders
Chromosome Aberrations
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Translocation, Genetic

ClinicalTrials.gov processed this record on February 08, 2010