Study of Tipifarnib in Patients With High-Risk Myelodysplastic Syndrome (MDS)

April 23, 2010 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

An Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of the Farnesyl-Transferase Inhibitor ZARNESTRA(tm) (R115777) in Subjects With High-Risk Myelodysplastic Syndrome (MDS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Treatment with tipifarnib will be given during one or more periods of time called cycle(s). Each cycle will be 28 days long and patients will take tipifarnib for the first 21 days of each cycle. No medication will be taken during the last 7 days of each cycle. On day 1 and 15 of each cycle, patients will be asked about any side effects that have occurred since their last visit. Blood will drawn for routine testing to evaluate any possible effects of tipifarnib on white blood cells or on specific elements, that can be measured in the blood. The study doctor will decide if any bone marrow aspirates or biopsies should be taken. Tipifarnib will be given until the patient's disease worsens or they develop unacceptable side effects or until they withdraw consent to receive tipifarnib. When tipifarnib treatment is ended or if the patient leaves the study early, they will be asked to come in for a final visit. The study doctor will decide if any blood draws, bone marrow aspirates or biopsies need to be taken.

Tipifarnib is 300 mg administered orally as three 100 mg tablets twice daily for the first 21 days in each 28-day cycle. Tipifarnib will be administered until the patient discontinues treatment due to disease progression or unacceptable toxicity.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion (ACTUAL)

May 1, 2006

Study Registration Dates

First Submitted

November 22, 2002

First Submitted That Met QC Criteria

November 22, 2002

First Posted (ESTIMATE)

November 25, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2010

Last Update Submitted That Met QC Criteria

April 23, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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