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

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

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.