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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00073450
Recruitment Status : Terminated
First Posted : November 24, 2003
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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
Carcinoma, Squamous Cell Head and Neck Neoplasms Drug: Farnesyl Protein Transferase Inhibitor Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : September 2003
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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More Information
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Publications of Results:

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00073450    
Other Study ID Numbers: P02530
First Posted: November 24, 2003    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015
Keywords provided by Merck Sharp & Dohme Corp.:
Squamous Cell Carcinoma of the Head & Neck
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site