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Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Chronic, Blast Crisis, Leukemia, Lymphocytic

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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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