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

Phase 2

Terminated

• Conditions: Carcinoma, Squamous Cell; Head and Neck Neoplasms

• Registration Number: NCT00073450
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2003-11-20
• Study First Submitted QC: 2003-11-21
• Study First Posted: 2003-11-24
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP