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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Drug: Farnesyl Protein Transferase Inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00034684

P00701

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)