At a glance
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A Phase II Study of Duvelisib Plus Docetaxel in PD-1 Inhibitor Experienced Patients With Incurable Head and Neck Squamous Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating Duvelisib and Docetaxel for Squamous Cell Carcinoma of the Head and Neck (SCCHN) and 4 related conditions. Completed, enrolled 26 participants across 1 site.
Detailed Summary
This trial that is investigating a medication called duvelisib in combination with docetaxel for the treatment of squamous cell carcinoma of the head and neck (SCCHN) that has returned or spread outside the head and neck area. The names of the study drugs involved in this study are: * Duvelisib (PI3K inhibitor) * Docetaxel chemotherapy
Study Details
Timeline
Interventions
Duvelisib capsules should be swallowed whole with a glass of water (approximately 8 ounces). Advise patients not to open, break, or chew the capsules. Duvelisib may be administered without regard to meals; however, subjects should avoid grapefruit and grapefruit juice while on duvelisib. continue for up to 24 months.
Docetaxel chemotherapy once every 21 days (by intravenous infusion) over about 30- 60 minutes at each visit. This will continue for up to 24 months