Study of Tipifarnib as Postconsolidation Therapy for Acute Myeloid Leukemia in Patients 60 Years and Older
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ZARNESTRA, tipifarnib, R115777
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Zarnestra, Acute myeloid leukemia, Tipifarnib
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
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00048503
First Posted
November 1, 2002
Last Updated
April 23, 2010
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00048503
Brief Title
Study of Tipifarnib as Postconsolidation Therapy for Acute Myeloid Leukemia in Patients 60 Years and Older
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Zarnestra, Acute myeloid leukemia, Tipifarnib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ZARNESTRA, tipifarnib, R115777
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study of Tipifarnib as Postconsolidation Therapy for Acute Myeloid Leukemia in Patients 60 Years and Older
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