Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia (Study P00701)

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00034684

Collaborator

(none)

132

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) as a single agent in patients with Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia in Blast Crisis, or Acute Lymphoblastic Leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Myelodysplastic Syndromes Leukemia, Myeloid, Chronic Blast Crisis Leukemia, Lymphocytic	Drug: Farnesyl Protein Transferase Inhibitor	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

132 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2001

Actual Primary Completion Date :

Oct 1, 2003

Actual Study Completion Date :

Oct 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.