Study Evaluating SKI-606 in Philadelphia Chromosome Positive Leukemias
Tracking Information| Start Date ICMJE | January 2006 |
|---|
| Estimated Primary Completion Date | June 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 ICMJE | Same as current |
|---|
| Change History | Complete list of historical versions of study NCT00261846 on ClinicalTrials.gov Archive Site |
|---|
| Current Secondary Outcome Measures ICMJE | |
|---|
| Original Secondary Outcome Measures ICMJE | |
|---|
Descriptive Information| Brief Title ICMJE | Study Evaluating SKI-606 in Philadelphia Chromosome Positive Leukemias |
|---|
| Official Title ICMJE | A 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 Phase | Phase I, Phase II |
|---|
| Study Type ICMJE | Interventional |
|---|
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
|---|
| Condition ICMJE | Leukemia, Myeloid, Chronic |
|---|
| Intervention ICMJE | Drug: SKI-606 |
|---|
| Study Arms / Comparison Groups | SKI-606: Experimental Intervention: Drug: SKI-606 |
|---|
Recruitment Information| Estimated Enrollment ICMJE | 459 |
|---|
| Estimated Completion Date | June 2010 |
|---|
| Estimated Primary Completion Date | June 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)
|
|---|
| Gender | Both |
|---|
| Ages | 18 Years and older |
|---|
| Accepts Healthy Volunteers | No |
|---|
| Contacts ICMJE | |
|---|
| Location Countries ICMJE | United 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| NCT ID ICMJE | NCT00261846 |
|---|
| Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
|---|
| Study ID Numbers ICMJE | 3160A4-200 |
|---|
| Study Sponsor ICMJE | Wyeth |
|---|
| Collaborators ICMJE | |
|---|
| Investigators ICMJE | | Study Director: | Medical Monitor | Wyeth | |
|
|---|
| Information Provided By | Wyeth |
|---|
|
