Study Evaluating SKI-606 in Philadelphia Chromosome Positive Leukemias 

Tracking Information

Start Date  ICMJEJanuary 2006
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
Efficacy; Pharmacokinetics [ Time Frame: Timeframe not specified ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00261846 on Archive Site
Current Secondary Outcome Measures ICMJE 
Original Secondary Outcome Measures ICMJE 

Descriptive Information

Brief Title  ICMJEStudy Evaluating SKI-606 in Philadelphia Chromosome Positive Leukemias
Official Title  ICMJEA Phase 1/2 Study of SKI-606 in Philadelphia Chromosome Positive Leukemias
Brief Summary

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.

Detailed Description 
Study PhasePhase I, Phase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJELeukemia, Myeloid, Chronic
Intervention  ICMJEDrug: SKI-606
Study Arms / Comparison GroupsSKI-606: Experimental
Intervention: Drug: SKI-606

Recruitment Information

Estimated Enrollment  ICMJE459
Estimated Completion DateJune 2010
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Trial
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Brazil,   Canada,   Chile,   China,   Colombia,   Finland,   Germany,   Hong Kong,   Hungary,   India,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Peru,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Taiwan,   United Kingdom

Administrative Information

Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study ID Numbers  ICMJE3160A4-200
Study Sponsor  ICMJEWyeth
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorWyeth
Information Provided ByWyeth