NCT00038597CompletedPhase 2
Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)
M.D. Anderson Cancer Center1 site in 1 country13 target enrollmentStarted: April 30, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 13
- Locations
- 1
Study Overview
Brief Summary
The goal of this research is to see if giving the drug SCH66336 by mouth can improve the disease in patients with chronic or accelerated phase CML. The safety of this treatment will also be studied.
Detailed Description
Objectives for this study are two-fold:
- To determine the efficacy of SCH66336 in patients with chronic phase and accelerated phase CML in relation to response rate, duration of response, and survival.
- To assess the toxicity of SCH66366 in these patients.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Philadelphia chromosome (Ph) -positive CML in chronic or accelerated phase;
- •Failure to respond to or intolerance to imatinib mesylate (Gleevec);
- •Age >/= 16 years;
- •Life expectancy of >/= 2 months;
- •Performance status 2 or better (Zubrod);
- •Adequate renal and hepatic functions (creatinine and bilirubin </= 2 mg/dl);
- •Adequate cardiac function;
- •Not candidates for or have refused allogeneic transplantation;
- •Patients should not be receiving azoles (ketoconazole, itraconazole, fluconazole), macrolides, HIV protease inhibitors, cyclosporin or anti-seizure drugs (phenobarbital, phenytoin, carbamazepine), rifampin or isoniazid.
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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