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

Phase 1

Completed

• Conditions: Leukemia; Myelodysplastic Syndromes; Leukemia, Myeloid, Chronic; Blast Crisis; Leukemia, Lymphocytic

• Registration Number: NCT00034684
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2002-05-01
• Study First Submitted QC: 2002-05-01
• Study First Posted: 2002-05-02
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-16
• Last Update Posted: 2015-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL