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

Completed · Phase 1

Conditions studied: Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx

In brief

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.

Key facts

Study ID

NCT01921426

Run by

Galera Therapeutics, Inc.

People needed

30

Starts

2013-08-01

Expected to finish

2016-08-01

Last updated by the study team

2016-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Summa Health System- Cooper Cancer Center — Akron, Ohio, United States
• St. Luke's Cancer Center — Easton, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Cancer Care Northwest — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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