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

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00073450
• Other study ID #: P02530
• Status: Terminated
• Phase: Phase 2
• First received: November 20, 2003
• Last updated: April 20, 2015
• Start date: September 2003
• Est. completion date: June 2004

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms

Intervention

Drug:
• Farnesyl Protein Transferase Inhibitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 — View Citation