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Tipifarnib in Older Patients With Untreated AML
NCT00093418Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2004
- Primary completion
- Jun 2006
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Small Molecules
- Drugs
- tipifarnib
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 2, randomised, open-label trial of tipifarnib in acute myeloid leukemia (AML) (4 arms), sponsored by National Cancer Institute. Primary endpoint: Total Response Rate (CR + PR) up to 3 years. Started Sep 2004; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
Continuous High Dose
Tipifarnib BID Days 1-21 q28d
Split High Dose
Tipifarnib BID Days 1-7, 15-21 q28d
Continuous Low Dose
Tipifarnib BID Days 1-21 q28d (Lower dose)
Split Low Dose
Tipifarnib BID Days 1-7, 15-21 q28d (Lower dose)
03
Who it enrols
Patients aged 70 or older with previously untreated AML, not candidates for standard chemotherapy. Prior MDS allowed but no prior induction chemo. Adequate organ function required.
04
Endpoints
Primary
Total Response Rate (CR + PR)
Secondary
Frequency and Severity of Toxicities
Relationship of Cytogenetics with Response
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