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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00048503
First received: November 1, 2002
Last updated: April 23, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: ZARNESTRA, tipifarnib, R115777
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Phase 2 Study of the Farnesyl Transferase Inhibitor ZARNESTRA (R115777) as Post-consolidation Therapy for Acute Myeloid Leukemia (AML) in Patients Age 60 Years and Older.

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The primary objective is to determine relapse-free survival (RFS) at 1 year in patients, 60 years and older with AML, who receive tipifarnib treatment.

Secondary Outcome Measures:
  • Secondary objectives, assess: overall survival; time to relapse; the safety profile of treatment with tipifarnib; the population pharmacokinetics of tipifarnib; DNA analysis of genetic variability; RNA analysis of differential gene expression.

Enrollment: 88
Study Start Date: June 2002
Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048503

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00048503     History of Changes
Obsolete Identifiers: NCT00057824, NCT00723034
Other Study ID Numbers: CR004033
Study First Received: November 1, 2002
Last Updated: April 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Zarnestra
Acute myeloid leukemia
Tipifarnib

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Tipifarnib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014