A Phase 2 Study of Farnesyl Transferase Inhibitor (R115777, Tipifarnib) in Patients With Refractory or Relapsed Acute Myeloid Leukemia.

• Status: Completed
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness (response rate) and safety of tipifarnib in patients with refractory or relapsed AML.

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

Details

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

Criteria

Inclusion Criteria:

• Refractory or relapsed Acute myeloid leukemia (AML)

• Eastern Cooperative Oncology Group (ECOG) performance of 0-2

• any value of WBC

• able to eat food and medication orally

• females must use contraception and not be pregnant

Exclusion Criteria:

• .Not in another study with an investigational agent within 3 weeks of tipifarnib administration

• must not have active CNS leukemia

• must not have disseminated intravascular coagulation (DIC) disorder with evidence of hemorrhage

• must not be allergic to imidazole drugs such as ketoconazole, miconazole, econazole, or terconazole.