Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the course of oral mucositis in subjects with head and neck cancer receiving concomitant chemotherapy and radiotherapy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alder Biopharmaceuticals, Inc.; CSL Behring

Criteria

Inclusion Criteria:

• Have recently diagnosed (< than 6 months prior to screening visit date), pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with CRT as first-line treatment; subjects with a history of surgical management (approximately 4-6 weeks before RT with sufficient time for post-surgical healing) are eligible

• Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 to 2.2 Gy, with a cumulative radiation dose between 55 and 72 Gy.

• Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to 100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2) or a standard carboplatin regimen administered weekly (100 mg/m2)

• Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

• CRP < 80 mg/L

• Have adequate hematopoietic, hepatic, and renal function at the screening visit

Exclusion Criteria:

• Tumor of the lips, sinuses, salivary glands, nasopharynx or unknown primary tumor

• Metastatic disease (M1) Stage IV C

• Any prior history of head and neck cancer

• Prior radiation to the head and neck

• Have had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; or anticipation of need for a major surgical procedure during the clinical trial

• Active infectious disease, excluding oral candidiasis

• Have OM at the screening visit

• Have a history of hypersensitivity to monoclonal antibody