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

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00073450

First received: November 20, 2003

Last updated: April 23, 2014

Last verified: April 2014

History of Changes

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 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

Genetics Home Reference related topics: head and neck squamous cell carcinoma

MedlinePlus related topics: Head and Neck Cancer

Genetic and Rare Diseases Information Center resources: Squamous Cell Carcinoma of the Head and Neck

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:


Enrollment:	15
Study Start Date:	September 2003
Study Completion Date:	June 2004
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

Publications:

Hanrahan EO, Kies MS, Glisson BS, Khuri FR, Feng L, Tran HT, Ginsberg LE, Truong MT, Hong WK, Kim ES. A phase II study of Lonafarnib (SCH66336) in patients with chemorefractory, advanced squamous cell carcinoma of the head and neck. Am J Clin Oncol. 2009 Jun;32(3):274-9. doi: 10.1097/COC.0b013e318187dd57.


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00073450 History of Changes
Other Study ID Numbers:	P02530
Study First Received:	November 20, 2003
Last Updated:	April 23, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:


Squamous Cell Carcinoma of the Head & Neck

Additional relevant MeSH terms:


Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms	Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on February 26, 2015

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