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Phase 2
18 Years
Open (Enrolling)
Head and Neck Neoplasms

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Trial Information

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.

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

- 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

Type of Study:


Study Design:

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

Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Jules Bordet Institute


Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

BAY 43-9006 Head and Neck



Start Date:

April 2005

Completion Date:

December 2007

Related Keywords:

  • Head and Neck Neoplasms
  • local recurrence and or metastatic disease
  • Previously treated with platinum
  • carcinoma of the head and neck
  • Neoplasms
  • Head and Neck Neoplasms