Status:
TERMINATED
Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Carcino...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00073450
Start Date
September 1 2003
End Date
June 1 2004
Last Update
April 21 2015
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