Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)
An Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
1 other identifier
interventional
15
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2003
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 20, 2003
CompletedFirst Posted
Study publicly available on registry
November 24, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedApril 21, 2015
April 1, 2015
9 months
November 20, 2003
April 20, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 19433965RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2003
First Posted
November 24, 2003
Study Start
September 1, 2003
Primary Completion
June 1, 2004
Study Completion
June 1, 2004
Last Updated
April 21, 2015
Record last verified: 2015-04