A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety, tolerability, and the highest dose of GC4419 that can be given to patients with squamous cell cancer of the head and neck who are receiving standard radiation therapy and chemotherapy. This study will also evaluate GC4419 for the following:

• Effect on the incidence and severity of radiation induced oral mucositis;

• Effect on the response rate of squamous cell cancer of the head and neck who are receiving radiation therapy and chemotherapy;

• Total concentrations of GC4419 that can be achieved in the blood;

• Changes in proteins and genetics associated with oral mucositis;

• Impact on delayed toxicities of radiation (dry mouth and reduced ability to fully open the mouth);

• Observe changes in genetic and molecular markers of oral mucositis;

• Observe the usage of extra health resources (e.g., unplanned ER visits, feeding tube use, etc.) of study patients;

• Assess the overall quality of life in study patients with oral mucositis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galera Therapeutics, Inc.
• Treatments: Avasopasem manganese; Superoxide Dismutase

Criteria

Inclusion Criteria:

• Pathologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN), defined as SCC of the oral cavity or oropharynx, that will be treated with standard cisplatin and Intensity-Modulated Radiation Therapy (IMRT)

• Males or females aged 18 years or older

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• Adequate bone marrow, liver and kidney function

• Negative serum pregnancy test for females of childbearing potential

• Properly obtained written informed consent

Exclusion Criteria:

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

• Metastatic disease (Stage IV C)

• Prior chemotherapy for SCCHN and/or radiotherapy to the region of the study cancer or

• Receiving any agent classified as an antioxidant

• History of malignant tumors other than SCCHN within the last 5 years, except non-melanoma skin cancer or curatively excised in situ cervical carcinoma

• Active infectious disease excluding oral candidiasis

• Presence of oral mucositis at study entry

• Chronic immunosuppression

• Known history of HIV or active hepatitis B/C )

• Prior history of hearing impairment

• Use of investigational agent within 30 days of study entry

• Known allergies or intolerance to cisplatin and similar platinum-containing compounds

• Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure