

Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EC-18 in altering the severity and course of oral mucositis in patients being treated with concomitant chemoradiation therapy for cancers of the mouth, oropharynx, hypopharynx and nasopharynx
Physician
Gary Lu, MD, PhD
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Treatment Agent: EC-18
Synopsis: The purpose of Stage 1 of this research study is to measure the safety of the study drug EC-18 at different dosages in patients being treated with chemoradiation for cancers of the mouth, oropharynx, hypopharynx and nasopharynx.
Sometimes it is not known which way of treating patients is best. To find out, researchers need to compare different treatments. People are put into groups and each group given a different treatment. The results are compared to see if one is better. To try to make sure the groups are the same to start with, each patient is assigned to a group by chance (randomly). Stage 1 of this study, is called a “dose-finding” stage. This means that the dose level of the study drug EC-18 may be different for each patient. Twenty-four (24) patients will be equally randomized (divided) into 4 groups to receive a dosage of either EC-18 500 mg, EC-18 1000 mg, EC-18 2000 mg or placebo. A placebo is a medication which looks exactly like the investigational drug but has no active ingredient. You, your study doctor and study staff will not know what dosage you are receiving or if you are receiving placebo. All the softgels look the same whether study medication or placebo.
The purpose of this study is to find out good and/or bad effects of the investigational drug, Imprime PGG, when given together with pembrolizumab in the treatment of your type of cancer. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). Imprime PGG is a glucan. Glucans are molecules that are not normally present in your body. Imprime PGG when given with pembrolizumab may help the immune system to fight your type of cancer. Pembrolizumab is already approved by the FDA when given alone for the treatment of advanced metastatic melanoma, non-small cell lung cancer, and in recurrent or metastatic SCCHN for patients with disease progression on or after platinum-containing chemotherapy. The combination of these drugs used in this study is also investigational.
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Unable to provide informed consent or, in the opinion of the Principal Investigator, comply with the protocol.
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Superoxide Dismutase Mimetic GC4419 to Reduce Severe Oral Mucositis (SOM) Associated with
Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck Cancer
Physician
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Treatment Agent: GC4419
Synopsis: The main purpose of this study is to further investigate whether fewer people getting radiation therapy and chemotherapy for head and neck cancer will get severe oral mucositis if they get GC4419 along with chemoradiation. This study will also investigate how many people get the most severe oral mucositis, how long it lasts, and how long it takes to occur. The safety of GC4419 will also be assessed in this study. To do this, the effects of GC4419 will be compared against a placebo (a substance that copies the appearance of the investigational drug but contains no active ingredient). This study will also investigate whether GC4419 has any effect on your cancer.
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A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
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Treatment Agent: Pembrolizumab
Synopsis: The purpose of this study is to:
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