Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors (Study P01964)(COMPLETED)

February 16, 2015 updated by: Merck Sharp & Dohme LLC

Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors

The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) when given in combination with intravenous docetaxel in cancer patients with advanced solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 1

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • Male or Female
  • Measurable or evaluable disease
  • No more than 2 prior chemotherapy regimens.
  • Age greater than or equal to 18.
  • Karnofsky Performance Status greater than or equal to 70%.
  • Meets protocol requirements for specified laboratory values.
  • No manifestations of a malabsorption syndrome.
  • Written informed consent and cooperation of patient
  • Appropriate use of effective contraception if of child-bearing potential.

Exclusion:

  • Acute or chronic leukemia or multiple myeloma.
  • Evidence of 2 or more active malignancies, expect for in situ or adequately treated basal or squamous cell skin cancer.

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: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse Events
ECG
Laboratory Tests

Secondary Outcome Measures

Outcome Measure
Pharmacokinetics
Tumor Response
Physical Exam

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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

June 1, 2001

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

June 28, 2002

First Submitted That Met QC Criteria

June 28, 2002

First Posted (Estimate)

July 1, 2002

Study Record Updates

Last Update Posted (Estimate)

February 18, 2015

Last Update Submitted That Met QC Criteria

February 16, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P01964

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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