NCT00048503

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2002

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2002

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

First QC Date

November 1, 2002

Last Update Submit

April 23, 2010

Conditions

Acute Myeloid Leukemia

Keywords

ZarnestraAcute myeloid leukemiaTipifarnib

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Interventions

ZARNESTRA, tipifarnib, R115777DRUG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

tipifarnib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

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

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 2002

First Posted

November 4, 2002

Study Start

June 1, 2002

Study Completion

November 1, 2005

Last Updated

April 27, 2010

Record last verified: 2010-04