A Dose Finding Study of R115777 (NSC 702818) in Patients With Advanced Hematologic Malignancies
Overview
- Phase
- Phase 1
- Intervention
- tipifarnib
- Conditions
- Chronic Myeloproliferative Disorders
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 36
- Locations
- 1
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Randomized phase I trial to study the effectiveness of tipifarnib in treating patients who have advanced hematologic cancer. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
Detailed Description
OBJECTIVES: I. Determine the relationship between tipifarnib dose and inhibition of farnesylation in malignant cells of patients with advanced hematologic malignancies. II. Determine the safety profile of this drug in this patient population. III. Determine the clinical activity of this drug in these patients. OUTLINE: This is a randomized study. Patients are randomized to 1 of 4 dose levels. Patients receive oral tipifarnib twice daily for 21 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 1 course of therapy, patients may receive subsequent therapy at the maximum tolerated dose at the investigator's discretion.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients receive oral tipifarnib twice daily for 21 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 1 course of therapy, patients may receive subsequent therapy at the maximum tolerated dose at the investigator's discretion.
Intervention: tipifarnib
Outcomes
Primary Outcomes
Not specified