NCT00073450TerminatedPhase 2
An Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 15
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically or cytologically proven squamous cell carcinoma of the head & neck.
- •Age greater than or equal to
- •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.
Investigators
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