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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Terminated
CT.gov ID
NCT00073450
Collaborator
(none)
15
Enrollment
9
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Farnesyl Protein Transferase Inhibitor
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
Study Start Date :
Sep 1, 2003
Actual Primary Completion Date :
Jun 1, 2004
Actual Study Completion Date :
Jun 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT00073450
    Other Study ID Numbers:
    • P02530
    First Posted:
    Nov 24, 2003
    Last Update Posted:
    Apr 21, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Merck Sharp & Dohme LLC
    Squamous Cell Carcinoma of the Head & Neck
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Squamous Cell Carcinoma of Head and Neck
    Head and Neck Neoplasms

    Study Results

    No Results Posted as of Apr 21, 2015