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

An Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck

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.

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.