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

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.