NCT03437941

Study to Evaluate CORT125281 in Combination With Enzalutamide in Patients With mCRPC

Completed Phase 1, PHASE2 Last updated 6 May 2023

What this trial tests

Phase 1, PHASE2 trial testing CORT125281 in Metastatic Castration-Resistant Prostate Cancer in 39 participants. Completed in 9 January 2023.

Timeline

15 December 2017

Primary endpoint
9 January 2023

9 January 2023

Quick facts

Lead sponsor	Corcept Therapeutics
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	39
Start date	15 December 2017
Primary completion	9 January 2023
Estimated completion	9 January 2023
Sites	8 locations across United Kingdom, United States

Drugs / interventions tested

• CORT125281 — full drug profile →
• Enzalutamide (Xtandi) — full drug profile →
• Placebo

Conditions studied

• Metastatic Castration-Resistant Prostate Cancer — all drugs for Metastatic Castration-Resistant Prostate Cancer →

Sponsor

Corcept Therapeutics — full company profile →

Who can join

18 and older, male only, with Metastatic Castration-Resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, Phase 1/2a dose escalation study with an expansion phase to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and preliminary efficacy of CORT125281 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) to identify a recommended dose (RD) for Phase 2 studies.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Enzalutamide-resistant castration-resistant prostate cancer: challenges and solutions.
   Tucci M, Zichi C, Buttigliero C, Vignani F, et al · · 2018 · cited 62× · PMID 30425524 · DOI 10.2147/ott.s153764
2. Targeting the PI3K/AKT Pathway Overcomes Enzalutamide Resistance by Inhibiting Induction of the Glucocorticoid Receptor.
   Adelaiye-Ogala R, Gryder BE, Nguyen YTM, Alilin AN, et al · · 2020 · cited 44× · PMID 32371590 · DOI 10.1158/1535-7163.mct-19-0936
3. Second-Generation Androgen Receptor Antagonists as Hormonal Therapeutics for Three Forms of Prostate Cancer.
   Rajaram P, Rivera A, Muthima K, Olveda N, et al · · 2020 · cited 39× · PMID 32456317 · DOI 10.3390/molecules25102448
4. Molecular Mechanisms Related to Hormone Inhibition Resistance in Prostate Cancer.
   Mollica V, Di Nunno V, Cimadamore A, Lopez-Beltran A, et al · · 2019 · cited 35× · PMID 30642011 · DOI 10.3390/cells8010043
5. Genome-wide crosstalk between steroid receptors in breast and prostate cancers.
   Paakinaho V, Palvimo JJ, Palvimo JJ. · · 2021 · cited 29× · PMID 34137734 · DOI 10.1530/erc-21-0038
6. Prognostic Significance of Glucocorticoid Receptor Expression in Cancer: A Systematic Review and Meta-Analysis.
   Bakour N, Moriarty F, Moore G, Robson T, et al · · 2021 · cited 28× · PMID 33916028 · DOI 10.3390/cancers13071649
7. Nuclear receptors in health and disease: signaling pathways, biological functions and pharmaceutical interventions.
   Jin P, Duan X, Huang Z, Dong Y, et al · · 2025 · cited 21× · PMID 40717128 · DOI 10.1038/s41392-025-02270-3
8. Glucocorticoid Receptor Regulates and Interacts with LEDGF/p75 to Promote Docetaxel Resistance in Prostate Cancer Cells.
   Sanchez-Hernandez ES, Ochoa PT, Suzuki T, Ortiz-Hernandez GL, et al · · 2023 · cited 11× · PMID 37626856 · DOI 10.3390/cells12162046