Efficacy and Activity of BAY 43-9006 in Patients With Recurrent and/or Metastatic Head and Neck Cancer

NCT ID: NCT00199160

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2010-06-30

Brief Summary

This is a Phase II trial evaluating the efficacy and the biological activity of BAY 43-9006 in patients with recurrent and/or metastatic head and neck cancer.

Detailed Description

This is a Phase II trial evaluating the efficacy and the biological activity of BAY 43-9006 in patients with recurrent and/or metastatic head and neck cancer.

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

BAY 43-9006

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female patients (18 years old and above), with a histologically proven, measurable, locally recurrent, and/or metastatic head and neck tumor.
• > 4 weeks since major surgery
• > 4 weeks since prior chemotherapy
• > 3 weeks since prior therapy with biological agents (Interleukin-2 [IL-2], interferon, other molecular-targeted therapies [except Ras/Raf inhibitors]).
• Performance status < 2
• Life expectancy > 3 months.
• At least one uni-dimensional measurable lesion by computed tomography (CT)-scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST)
• Adequate liver, pancreatic, renal, and coagulation function
• A slide or paraffin-block from a tumor biopsy MUST be available at the time of screening. If the original diagnostic biopsy is not available at the time of screening, an additional biopsy is required.

Exclusion Criteria

• Severe preexisting conditions
• Evidence of bone marrow suppression
• Frequent vomiting or medical condition, which could interfere with oral medication intake
• Lack of resolution of all toxic manifestations of prior chemotherapy, biologic, or radiation therapy (alopecia excluded).
• Known HIV positivity or AIDS-related illness.
• Previous exposure to a Ras/Raf inhibitor
• Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis and T1] or other malignancies curatively treated > 2 years prior to entry)
• Congestive heart failure
• Cardiac arrhythmias requiring anti-arrhythmics
• Active coronary artery disease or ischaemia
• Active clinically serious bacterial or fungal infections
• Known brain or meningeal metastases
• Patients with seizure disorder requiring medication (such as anti-epileptics)
• Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• Known or suspected allergy to the investigational agent or any agent given in association with this trial
• Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test.
• Concurrent anti-cancer chemotherapy or immunotherapy is excluded
• Significant surgery within four weeks prior to start of study drug
• Investigational drug therapy outside of this trial, or any chemotherapy during or within 4 weeks prior to start of study drug
• Myelosuppressive radiotherapy within four weeks prior to start of study drug (short-course non-myelosuppressive radiotherapy may be allowed based on approval of principal investigators)
• Concomitant treatment with ketoconazole, itraconazole, ritonavir, or use of grapefruit juice

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AHMAD AWADA

Role: PRINCIPAL_INVESTIGATOR

Jules Bordet Institute

Locations

Jules Bordet Institute

Brussels, , Belgium

Countries

Belgium

Other Identifiers

BAY 43-9006 Head and Neck

Identifier Type: -

Identifier Source: org_study_id