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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00811070 |
This is a two-part safety and efficacy study of SKI-606 in subjects who have Philadelphia chromosome positive leukemias (CML). Part 1 will be a dose-escalation study, in which an escalating dose of SKI-606, up to 600 mg, will be studied in subjects with imatinib resistant/refractory or imatinib intolerant chronic phase CML. Part 2 will evaluate the safety and efficacy of the maximum tolerated dose (MTD) of SKI-606 identified in Part 1 of the study.
Condition | Intervention | Phase |
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Chronic Myelogenous Leukemia |
Drug: SKI-606 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1/2 Study of SKI-606 Administered as a Single Agent in Japanese Subjects With Philadelphia Chromosome Positive Leukemias |
Estimated Enrollment: | 36 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: SKI-606 |
Ages Eligible for Study: | 20 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria 1. Cytogenetic or Polymerase Chain Reaction based diagnosis of Chronic phase of Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Part 1), any phase of Philadelphia Chromosome Positive Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphocytic Leukemia (Part 2), whose disease is resistant/refractory to full-dose imatinib (400 mg for chronic phase subjects/600 mg for advanced leukemia subjects), or are intolerant of any dose of imatinib. 2. Adequate duration of prior imatinib therapy. 3. No prior exposure to Src, Abl, or Src/Abl kinase inhibitors other than imatinib. 4. Eastern Cooperative Oncology Group Performance Status of 0 or 1 for chronic phase subjects, and 0, 1 or 2 for Advanced Stage subjects. 5. At least 7 days since any anti-proliferative treatment (including intrathecal chemotherapy) before the first dose of SKI-606, (except hydroxyurea). 6. Recovered to National Cancer Institute grade 0-1, or to baseline, from any toxicities of prior anti-tumor treatment, other than alopecia or thrombocytopenia due to active prior treatment (intolerant subjects). 7. At least 3 months post allogeneic stem cell transplantation before the first dose of SKI-606. 8. Able to take daily oral capsules reliably. 9. Absolute neutrophil count greater than 1,000/mL (Part 1) 10. Adequate hepatic, and renal function. 11. Documented normal INR if not on oral anticoagulant therapy, or, if on oral anticoagulant therapy consistent target INR less than 3. 12. Age should be greater than 20 years and less than 75 years (Part 1), greater than 20 years (Part 2), including women of childbearing potential. 13. Willingness of male and female subjects, who are not surgically sterile or postmenopausal, must agree and commit to the use of reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods used with a spermicide) for the duration of the study and for 30 days after the last dose of SKI-606.
Exclusion Criteria
Contact: Trial Manager | clintrialparticipation@wyeth.com |
Principal Investigator: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3160A4-2203 |
Study First Received: | December 17, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00811070 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Chromosomal abnormalities Philadelphia Chromosome Leukemia Chronic myelogenous leukemia Hematologic Diseases |
Myeloproliferative Disorders Chromosome Aberrations Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Pathologic Processes Neoplasms by Histologic Type Translocation, Genetic |