Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 2

Conditions: Myelogenous Leukemia, Chronic

Treatments: Drug: SCH66336

Study type: Interventional

Funder types: Other

Identifiers

NCT00038597

DM01-072

Details and patient eligibility

About

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.

Full description

Objectives for this study are two-fold:

1. 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.
2. To assess the toxicity of SCH66366 in these patients.

Enrollment: 13 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)