Trial Information

Summary: If the patient has incurable Head & Neck cancer and has failed at least one course of standard platinum based chemotherapy, he/she may be eligible for this clinical trial.

Physicians are currently seeking subjects to participate in this open label, single-arm phase II clinical research study of an investigational agent. Patients will receive treatment with zalutumumab in combination with best supportive care (BSC), i.e., weekly infusions of zalutumumab by means of individual titration until patient achieves skin rash CTCAE grade 2. After follow-up visit, patients will be followed for survival. Qualified subjects received all study-related evaluations and procedures related to the study at no cost.

Main Criteria:

1. Histologically or cytologically confirmed diagnosis of SCCHN.

2. Failure to at least one course of standard platinum-based chemotherapy.

3. Measurable disease defined as one or more lesions according to RECIST.

4. WHO performance status = 2.

5. Three or more prior chemotherapy regimens, other than platinum-based chemotherapy.

6. Prior treatments with EGFr antibodies and/or EGFr small molecule inhibitors.

7. Received cytotoxic or cytostatic anti-cancer chemotherapy within 4 weeks prior to Visit 1.

8. Life expectancy less than 3 months.

There are additional inclusion and exclusion criteria but they may be discussed with a study physician.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.