NCT00050154

Brief Summary

The purpose of this study is to characterize the hematological response rate, as well as other parameters of efficacy and safety induced by tipifarnib in patients with high-risk myelodysplastic syndrome (MDS). Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make cancer cells grow.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 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

July 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2002

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

First QC Date

November 22, 2002

Last Update Submit

April 23, 2010

Conditions

Myelodysplastic Syndrome

Keywords

R115777Myelodysplastic syndromesTipifarnibZarnestra

Outcome Measures

Primary Outcomes (1)

  • The purpose of this research study is to determine if tipifarnib leads to a complete response for in patients with high-risk Myelodysplastic Syndrome (MDS).

Secondary Outcomes (1)

  • Efficacy will be assessed by evaluation of bone marrow and hematologic laboratory tests. Safety will be assessed by evaluation of adverse events and clinical laboratory tests.

Interventions

ZARNESTRA, tipifarnib, R115777DRUG

Eligibility Criteria

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

You may qualify if:

  • Pathological evidence of MDS
  • Not more than 1 prior cytotoxic treatment for MDS
  • Able to take oral study drug
  • Able to understand and provide signed informed consent

You may not qualify if:

  • Refractory anemia (RA) or RA with excess of blasts (RAEB) or patients with RAEB with \< or = 10% marrow blasts
  • Treatment-related MDS, if treated with chemotherapy less than 3 years ago
  • Not adequately recovered from any treatment-related non-hematological toxicity
  • Refractory to platelet transfusion
  • Candidates for hematopoietic stem cell transplantation
  • Previous therapy with a farnesyl transferase inhibitor
  • Prior extensive radiation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

tipifarnib

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic 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 22, 2002

First Posted

November 25, 2002

Study Start

July 1, 2002

Study Completion

May 1, 2006

Last Updated

April 27, 2010

Record last verified: 2010-04