Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers

Phase 2 Active not recruiting 46 enrolled Alliance for Clinical Trials in Oncology Astellas Pharma US, Inc. · collab National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well enzalutamide works in treating patients with androgen receptor positive salivary cancers that have spread from where it started to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Proteins called androgen receptors bind to androgens (hormones) and may cause tumor cells to grow. Enzalutamide may stop the growth of tumor cells by binding to and blocking androgen receptor proteins.

Timeline

Start: 2016-09-14
Primary completion: 2019-02-21
Completion: 2028-07-05

Outcome

Missed primary endpoint

paper Enzalutamide demonstrated limited activity in AR+ SGC, failing to meet protocol-defined success in part because of a lack of response durability. PMID 35867947 ↗

Publications

Ho AL, Foster NR, Zoroufy AJ, Campbell JD, Worden F, Price K, Adkins D, Bowles DW, Kang H, Burtness B, Sherman E, Morton R, Morris LGT, Nadeem Z, Katabi N, Munster P, Schwartz GK. Phase II Study of Enzalutamide for Patients With Androgen Receptor-Positive Salivary Gland Cancers (Alliance A091404). J Clin Oncol. 2022 Dec 20;40(36):4240-4249. doi: 10.1200/JCO.22.00229. Epub 2022 Jul 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enzalutamide	Other / unclassified	160 mg	Oral