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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Squamous Cell, Head and Neck Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

P02530

NCT ID:

NCT00073450

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Squamous Cell Carcinoma of the Head & Neck
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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