Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)
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ClinicalTrials.gov Identifier: NCT00073450 |
Recruitment Status
:
Terminated
First Posted
: November 24, 2003
Last Update Posted
: April 21, 2015
|
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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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 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 |
Resource links provided by the National Library of Medicine

Genetics Home Reference related topics:
Head and neck squamous cell carcinoma
U.S. FDA Resources
Information from the National Library of Medicine

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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.
No Contacts or Locations Provided
Publications of Results:
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00073450 History of Changes |
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:
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Squamous Cell Neoplasms by Site Lonafarnib Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |