Study of Tipifarnib as Postconsolidation Therapy for Acute Myeloid Leukemia in Patients 60 Years and Older

NCT ID: NCT00048503

Last Updated: 2010-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2005-11-30

Brief Summary

The purpose of this study is to determine if giving tipifarnib after standard treatment will prevent leukemia from coming back (relapsing). Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make leukemia cells grow.

Detailed Description

The study is an open-label evaluation of treatment with tipifarnib in approximately 127 subjects, 60 years and older, with AML in complete remission (CR) after consolidation therapy. Prior to enrollment, patients will receive 1 or 2 cycles of induction chemotherapy. Patients who attain a CR will receive 1 or 2 cycles of consolidation chemotherapy. Patients in postconsolidation complete remission who meet the eligibility criteria are offered enrollment in the study. Subjects enrolled in the study are treated with tipifarnib A dose-modification scheme is followed to maintain adequate specified laboratory values and to minimize other adverse events. Postconsolidation treatment with tipifarnib continues until the time of relapse, death, completion of 24 cycles of treatment, or discontinuation as advised by study doctor.

Tipifarnib, film coated, compressed tablets containing 100 mg active drug, will be administered orally at a dose of 300 mg (three 100 mg film coated tablets) taken twice a day for 21 consecutive days on a 28-day cycle schedule for up to 24 months.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ZARNESTRA, tipifarnib, R115777

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Newly-diagnosed AML
• Leukemia in remission
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria

• Acute Promyelocytic Leukemia (APL)
• Previous History of myelodysplasia or antecedent hematologic malignancy
• Previous therapy with a farnesyl transferase inhibitor

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Other Identifiers

CR004033

Identifier Type: -

Identifier Source: org_study_id

NCT00057824

Identifier Type: -

Identifier Source: nct_alias

NCT00723034

Identifier Type: -

Identifier Source: nct_alias