NCT03809208 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cancer Genome Atlas Network
Comprehensive genomic characterization of head and neck squamous cell carcinomas. Nature. 2015 Jan 29;517(7536):576-82. doi: 10.1038/nature14129.
Eytan DF, Snow GE, Carlson S, Derakhshan A, Saleh A, Schiltz S, Cheng H, Mohan S, Cornelius S, Coupar J, Sowers AL, Hernandez L, Mitchell JB, Annunziata CM, Chen Z, Van Waes C
SMAC Mimetic Birinapant plus Radiation Eradicates Human Head and Neck Cancers with Genomic Amplifications of Cell Death Genes FADD and BIRC2. Cancer Res. 2016 Sep 15;76(18):5442-5454. doi: 10.1158/0008-5472.CAN-15-3317. Epub 2016 Jul 28.

A Phase I Study of Birinapant and Intensity Modulated Re-Irradiation Therapy (IMRRT) for Local-Regionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

Details for clinical trial NCT03809208

Clinical trial NCT03809208 - References