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

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 2

Conditions

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Treatments

Drug: Farnesyl Protein Transferase Inhibitor

Study type

Interventional

Funder types

Industry

Identifiers

NCT00073450

P02530

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.