Suspended

An Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck

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What is being tested

Data Collection

Who is being recruted

Squamous Cell Carcinoma of Head and Neck
+6

+ Carcinoma
+ Carcinoma, Squamous Cell
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitleAn Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck 
NCT00073450
Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
15 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
SuspendedNo study centers