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


Phase 2
16 Years
N/A
Not Enrolling
Both
Myelogenous Leukemia, Chronic

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Trial Information

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


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.

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
- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jorge Cortes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

DM01-072

NCT ID:

NCT00038597

Start Date:

April 2001

Completion Date:

May 2004

Related Keywords:

  • Myelogenous Leukemia, Chronic
  • Philadelphia chromosome positive CML
  • Myelogenous Leukemia, Chronic, Chronic Phase
  • Myelogenous Leukemia, Chronic, Accelerated Phase
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Chronic Disease

Name

Location
MDAnderson Cancer Center Houston, Texas  77030