NCT00354146

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2001

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

April 1, 2001

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
Last Updated

February 1, 2011

Status Verified

January 1, 2011

First QC Date

July 18, 2006

Last Update Submit

January 31, 2011

Conditions

Leukemia, Nonlymphocytic, Acute

Keywords

Farnesyl transferase inhibitorrelapsed or refractory acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

  • The objective is to determine the rate of complete remission or complete remission with incomplete platelet recovery induced by tipifarnib in patients with refractory or relapsed AML treated until disease progression or unacceptable toxicity occurs.

Secondary Outcomes (1)

  • These objectives are to determine the objective remission rate, duration of remission, time to disease progression/progression-free survival, overall survival, and the clinical benefit/quality of life (QOL). The safety profile will also be determined.

Interventions

tipifarnib (R115777)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteRecurrence

Interventions

tipifarnib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Johnson & Johnson Pharmaceutical Research & 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

July 18, 2006

First Posted

July 20, 2006

Study Start

April 1, 2001

Study Completion

July 1, 2003

Last Updated

February 1, 2011

Record last verified: 2011-01