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

NCT00199160 | Completed Phase 2

• 1 other identifier: BAY 43-9006 Head and Neck
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms

Keywords

local recurrence and or metastatic disease; Previously treated with platinum; carcinoma of the head and neck

Outcome Measures

Primary Outcomes (1)

• PFS

Interventions

BAY 43-9006 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Jules Bordet Institute

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• AHMAD AWADA

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 20, 2015

Record last verified: 2005-09

Locations

BE (1)