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Therapeutic Areas: Oncology
Disease Category: Head and Neck Cancer
Trial Information
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.
Tahira Carbone,
Sreenivasa Nattam, MD
Fort Wayne Medical Oncology and Hematology
Located in:
Fort Wayne, IN 46805-5099
Phone: 1-866-424-4280
EMail: scchn@us.genmab.com
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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