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An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck Clinical research trials and An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck. An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck  An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck
An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck
For Condition: Carcinoma, Squamous Cell,Head and Neck Neoplasms
Status: Recruiting
Sponsor(s): Schering-Plough ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Histologically or cytglogically 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 cirative 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.
Total Enrollment: 30
Location and Contact Information:
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Edward Kim 713-792-6363
Emory Unversity School of Medicine *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Fadlo Khuri 404-778-4250
Additional Information:
Study ID Numbers: P02530;
Study Start Date: September 2003
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073450
Other Carcinoma, Squamous Cell Studies:
1. A Phase IB Study Of Oral SCH 66336 Preoperatively In Patients With Head And Neck Squamous Cell Cancer
2. Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients
3. Study to Compare the Overall Survival of Patients Receiving INGN 201 (study drug) with Patients Receiving Methotrexate
4. Study Of Zd1839 (Iressa™) Versus Methotrexate For Previously Treated Patients With Squamous Cell Carcinoma Of The Head And Neck
5. Effectiveness and Safety of INGN 201 in Combination with Chemotherapy Versus Chemotherapy Alone
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An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck
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