A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Trial of the Effects of Intravenous GC4419 on the Incidence and Duration of Severe Oral Mucositis (OM) in Patients Receiving Post-Operative or Definitive Therapy with Single-Agent
The main purpose of this study is to compare the effects of one of two different dose levels of an investigational drug called GC4419 when given with the standard radiation therapy and chemotherapy for the treatment of head and neck cancers. This study drug is not yet approved by the FDA. The study will be looking at the effect that the drug GC4419 will have on mucositis, which is a side effect of the chemotherapy and radiation therapy for the treatment of head and neck cancers. Mucositis is painful inflammation and ulceration of the mucous membranes in the mouth and lining of the digestive tract. The study will evaluate whether there is any difference between the treatment with two different GC4419 doses and a placebo. This study will look at how long it takes for oral mucositis to occur, how frequently it occurs, and how severe it is in subjects that are taking GC4419 during their cancer treatment, as well as whether GC4419 has any effect on tumors of the head and neck. In addition to comparing the GC4419 to the placebo, this study will also compare the two doses of GC4419. If the study finds that one of the doses of GC4419 is more effective than the placebo and the side effects are acceptable, future studies may test GC4419 at that dose level.
Study phase: II
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Pathologically-confirmed diagnosis of squamous cell carcinoma of the head and neck, defined as SCC of the oral cavity or oropharynx that will be treated with cisplatin plus concurrent IMRT.
Aged 18 years or older, male and female patients
Primary disease category: Cancer
Sponsor: Galera Therapeutics
Protocol number: Protocol GT-201:
Projected enrollment dates: September 2015 to September 2020
Official study title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Trial of the Effects of Intravenous GC4419 on the Incidence and Duration of Severe Oral Mucositis (OM) in Patients Receiving Post-Operative or Definitive Therapy with Single-Agent Cisplatin plus IMRT for Locally Advanced, Non-Metastatic Squamous Cell Carcinoma of the Oral Cavity or Oropharynx