Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00073450
First received: November 20, 2003
Last updated: May 21, 2013
Last verified: May 2013
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:

U.S. FDA Resources

Further study details as provided by Merck:

Estimated Enrollment: 30
Study Start Date: September 2003
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
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00073450     History of Changes
Other Study ID Numbers: P02530
Study First Received: November 20, 2003
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Squamous Cell Carcinoma of the Head & Neck

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on May 23, 2013