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

Primary Purpose

Carcinoma, Squamous Cell, Head and Neck Neoplasms

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Farnesyl Protein Transferase Inhibitor
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Squamous Cell focused on measuring Squamous Cell Carcinoma of the Head & Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 20, 2003
    Last Updated
    April 20, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00073450
    Brief Title
    Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)
    Official Title
    An Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    September 2003 (undefined)
    Primary Completion Date
    June 2004 (Actual)
    Study Completion Date
    June 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Squamous Cell, Head and Neck Neoplasms
    Keywords
    Squamous Cell Carcinoma of the Head & Neck

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Farnesyl Protein Transferase Inhibitor

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19433965
    Citation
    Hanrahan EO, Kies MS, Glisson BS, Khuri FR, Feng L, Tran HT, Ginsberg LE, Truong MT, Hong WK, Kim ES. A phase II study of Lonafarnib (SCH66336) in patients with chemorefractory, advanced squamous cell carcinoma of the head and neck. Am J Clin Oncol. 2009 Jun;32(3):274-9. doi: 10.1097/COC.0b013e318187dd57.
    Results Reference
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    Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)

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