Zalutumumab in Non-curable Patients With SCCHN

Genmab

Status and phase: Completed; Phase 2

Conditions: Squamous Cell Cancer; Head and Neck Cancer

Treatments: Drug: Zalutumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00542308

GEN205

Details and patient eligibility

About

Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females age ≥ 18 years
2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
3. Failure to at least one course of standard platinum-based chemotherapy

Exclusion criteria

1. Three or more prior chemotherapy regimens
2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
3. Past or current malignancy other than SCCHN, except for certain other cancer diseases

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Zalutumumab 4-16 mg/kg

Experimental group

Description:

Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.

Treatment:

Drug: Zalutumumab