NCT00093990

Brief Summary

The purpose of this study is to determine the effectiveness of tipifarnib in patients aged 70 or more with acute myeloid leukemia. 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
457

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2004

Typical duration for phase_3

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

January 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2004

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

First QC Date

October 7, 2004

Last Update Submit

September 13, 2016

Conditions

Acute Myeloid Leukemia

Keywords

Myeloid leukemia acute diseaseTipifarnibBone marrow aspirate

Outcome Measures

Primary Outcomes (1)

  • Overall survival

Secondary Outcomes (1)

  • Compare patients treated with tipifarnib and patients treated with best supportive care: progression-free survival; complete remission rate; rate of morphologic leukemia-free state; one-year survival estimate and health resources utilization.

Interventions

Tipifarnib;Zarnestra; R115777DRUG

Eligibility Criteria

Age70 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Newly diagnosed or re-lapsing AML
  • Patient not medically fit for combination induction chemotherapy
  • Pathologic confirmation of AML (= or \> 20% bone marrow leukemic blasts)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.

You may not qualify if:

  • Previous cytotoxic or biologic treatment for AML
  • Acute promyelocytic leukemia (APL)
  • Central nervous system leukemia
  • Uncontrolled systemic infection
  • Uncompensated disseminated intravascular coagulation
  • Symptomatic neuropathy of grade 2 or worse
  • Known allergy to imidazole drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Harousseau JL, Martinelli G, Jedrzejczak WW, Brandwein JM, Bordessoule D, Masszi T, Ossenkoppele GJ, Alexeeva JA, Beutel G, Maertens J, Vidriales MB, Dombret H, Thomas X, Burnett AK, Robak T, Khuageva NK, Golenkov AK, Tothova E, Mollgard L, Park YC, Bessems A, De Porre P, Howes AJ; FIGHT-AML-301 Investigators. A randomized phase 3 study of tipifarnib compared with best supportive care, including hydroxyurea, in the treatment of newly diagnosed acute myeloid leukemia in patients 70 years or older. Blood. 2009 Aug 6;114(6):1166-73. doi: 10.1182/blood-2009-01-198093. Epub 2009 May 21.

    PMID: 19470696DERIVED

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 & Development, L.L. C. Clinical Trial

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2004

First Posted

October 11, 2004

Study Start

January 1, 2004

Study Completion

October 1, 2007

Last Updated

September 14, 2016

Record last verified: 2016-09