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

This study has been completed.

First Received: November 20, 2003 Last Updated: May 31, 2006 History of Changes

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00073450

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Squamous Cell Head and Neck Neoplasms	Drug: Farnesyl Protein Transferase Inhibitor	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Lonafarnib

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Estimated Enrollment:	30
Study Start Date:	September 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	P02530
Study First Received:	November 20, 2003
Last Updated:	May 31, 2006
ClinicalTrials.gov Identifier:	NCT00073450 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Squamous Cell Carcinoma of the Head & Neck

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Head and Neck Neoplasms

Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 27, 2009