A Phase 1 Dose Escalation Study of GC4419 in Combination With Radiation and Chemotherapy for Squamous Cell Cancers of the Head and Neck.

NCT01921426 Phase 1 COMPLETED

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.

Details

Lead sponsor	Galera Therapeutics, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	30
Start date	2013-08
Completion	2016-08

Conditions

• Squamous Cell Carcinoma of the Oral Cavity
• Squamous Cell Carcinoma of the Oropharynx

Interventions

• GC4419

Primary outcomes

• Frequency and Severity of Adverse Events Resulting from GC4419 — 14 - 35 days
  GC4419 will be evaluated to determine safety, tolerability, and the maximum tolerated dose of GC4419 that can be administered to patients with squamous cell cancer of the head and neck who are receiving concurrent radiation (50-70 Gy, administered daily x 5 \[M-F\], in 2.0-2.2 Gy fractions) and chemotherapy (cisplatin, 80-100mg/m2, q3 weeks or weekly cisplatin 30-40mg/m2 x 6 weeks). Patients will receive 14 - 35 doses of GC4419 in serially ascending cohorts for dose and duration, which correspond to the first doses of radiation, schedule dependent. Dose limiting toxicity will be evaluated through 24 hours following the last dose of GC4419.

Countries

United States