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