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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00073450

Enrollment

Registered

2003-11-24

Start date

2003-09-30

Completion date

2004-06-30

Last updated

2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Squamous Cell, Head and Neck Neoplasms

Keywords

Squamous Cell Carcinoma of the Head & 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.

Interventions

DRUGFarnesyl Protein Transferase Inhibitor

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026