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

• Status: Terminated
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

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.