ESK981 in Treating Patients With Metastatic Castrate-Resistant Prostate Cancer

Phase 2 Completed 13 enrolled Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

Summary

This phase II trials studies the side effects and how well ESK981 works in treating patients with castration-resistant prostate cancer that has spread to other places in the body. ESK981 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Timeline

Start: 2018-03-08
Primary completion: 2023-03-15
Completion: 2023-05-09

Outcome

Missed primary endpoint

paper Only one patient (7.7% two-sided 95% Wilson CI (0.4%, 33.3%)) experienced a reduction in their PSA levels by 50% or more. PMID 39227508 ↗

paper Although relatively well tolerated, ESK981 alone showed no anti-tumor activity in patients with AR + mCRPC PMID 39227508 ↗

Publications

Heath EI, Chen W, Heilbrun L, Choi JE, Dobson K, Smith M, Maj T, Vaishampayan U, Kryczek I, Zou W, Chinnaiyan AM, Qiao Y. Phase II trial of multi-kinase inhibitor ESK981 in patients with metastatic castration-resistant prostate cancer. Invest New Drugs. 2024 Oct;42(5):566-574. doi: 10.1007/s10637-024-01463-x. Epub 2024 Sep 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ESK981	Unknown	160 mg	Oral