Tipifarnib Versus Best Supportive Care in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effectiveness of tipifarnib in patients aged 70 or more with acute myeloid leukemia. Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make leukemia cells grow.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Tipifarnib

Criteria

Inclusion Criteria:

• Newly diagnosed or re-lapsing AML

• Patient not medically fit for combination induction chemotherapy

• Pathologic confirmation of AML (= or > 20% bone marrow leukemic blasts)

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.

Exclusion Criteria:

• Previous cytotoxic or biologic treatment for AML

• Acute promyelocytic leukemia (APL)

• Central nervous system leukemia

• Uncontrolled systemic infection

• Uncompensated disseminated intravascular coagulation

• Symptomatic neuropathy of grade 2 or worse

• Known allergy to imidazole drugs.