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Phase IIB Randomized, Placebo-Controlled Trial of ACTOplus Met® XR in Subjects with Stage I-IV Squamous Cell Carcinoma of the Oral Cavity or Oropharynx Prior to Definitive Treatment

The Schema is a timeline of the study. It indicates start/end points, visits expected, major testing to be done, and any other information that is crucial to understanding how the study was completed.



Schema Description

At visit 0 (baseline), medical history is reported, a physical examination is completed, and tissue and blood samples are taken from the participant. Participants are then randomized at a 2:1 ratio. One arm of participants is to receive ACTOplus Met® XR/Head and Neck, taking 1 tablet daily for 10-21 days (until surgery). The other arm of participants will receive a placebo, taking 1 tablet daily for 10-21 days (until surgery). At contact 1 (interim phone contact), adverse events are reported and compliance with study protocol is checked. At contact 2 (final dosing reminder phone contact), adverse events are reported and compliance with study protocol is checked. At visit 1 (end of study or early termination, prior to surgery), adverse events are reported and compliance with study protocol is checked. A physical examination is completed and a FDG-PET/CT is completed (only for participants who had a standard of care staging FDG-PET/CT scan prior to starting study intervention). Finally, tissue and blood samples are collected. At this point, the study is completed.