Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Chronic, Blast Crisis, Leukemia, Lymphocytic
Both
Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Chronic, Blast Crisis, Leukemia, Lymphocytic
Trial Information
Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia
Inclusion Criteria:
- Pathologically documented chronic myelogenous leukemia in blast crisis,
myelodysplasia, acute myelogenous leukemia, or acute lymphocytic leukemia.
- Life expectancy of 12 weeks or greater.
- ECOG Performance Status less than or equal to 2.
- Meets protocol requirements for specified laboratory values.
- No manifestations of a malabsorption syndrome.
Exclusion Criteria:
- Patients who have received more than three chemotherapy regimens for more than three
recurrences of the disease.
- Poor medical risks because of nonmalignant systemic disease as well as those with
active uncontrolled conditions.
- Patients who have received investigational therapy of any type within 30 days prior
to administration.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
P00701
NCT ID:
NCT00034684
Start Date:
July 2001
Completion Date:
March 2004
Related Keywords:
- Leukemia
- Myelodysplastic Syndromes
- Leukemia, Myeloid, Chronic
- Blast Crisis
- Leukemia, Lymphocytic
- Leukemia
- Myelodysplastic Syndromes
- Leukemia, Myeloid
- Leukemia, Lymphocytic
- Blast Crisis
- Leukemia
- Leukemia, Lymphoid
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Myelodysplastic Syndromes
- Preleukemia
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