Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)

April 20, 2015 updated by: Merck Sharp & Dohme LLC

An Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to determine the safety and efficacy of an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 6636) as a single agent in Adult Patients With Squamous Cell Carcinoma of the Head & Neck and will help determine if further development is justified.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

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:

  • Histologically or cytologically proven squamous cell carcinoma of the head & neck.
  • Age greater than or equal to 18.
  • ECOG performance status of 0 to 1
  • Measurable malignant disease.
  • Patients that have failed at least one platinum-containing regimen and have received no more than three prior regimens and do not have other curative treatment options.
  • Patients must be at least 2 wks post surgery or radiation therapy
  • Patients must be at least 4 weeks post chemotherapy
  • Meets protocol requirements for specified laboratory values.
  • Written informed consent and cooperation of patient.
  • Appropriate use of effective contraception if of childbearing potential.
  • No investigational drugs of any type within 30 days prior to administration.

Exclusion Criteria:

  • Prior exposure to farnesyl transferase inhibitors
  • Medical conditions that would interfere with taking oral medications.
  • Patients with significant QTc prolongation at baseline (>500 msec.)
  • Pregnant or nursing women
  • Known HIV positivity or AIDS-related illness.
  • Concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy
  • Patients with any signs of involvement of the dura, meninges, or brain.
  • Patients with squamous cell carcinoma of the nasopharynx
  • Patients who currently have other cancers or have been treated in the last 5 years for any other malignancy.

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 Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2003

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

November 20, 2003

First Submitted That Met QC Criteria

November 21, 2003

First Posted (Estimate)

November 24, 2003

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P02530

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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