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

Tracking Information
First Received Date ^ICMJE	November 20, 2003
Last Updated Date	May 31, 2006
Start Date ^ICMJE	September 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00073450 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)(COMPLETED)
Official Title ^ICMJE	An Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
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
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Carcinoma, Squamous Cell Head and Neck Neoplasms
Intervention ^ICMJE	Drug: Farnesyl Protein Transferase Inhibitor
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00073450
Responsible Party
Study ID Numbers ^ICMJE	P02530
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP