Status:
COMPLETED
Efficacy and Activity of BAY 43-9006 in Patients With Recurrent and/or Metastatic Head and Neck Cancer
Lead Sponsor:
Jules Bordet Institute
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00199160
Start Date
April 1 2005
End Date
June 1 2010
Last Update
May 20 2015
Active Locations (1)
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1
Jules Bordet Institute
Brussels, Belgium, 1000