Study of Drug 1 (Enzalutamide) Plus Drug 2 (Relacorilant) for Patients With Prostate Cancer

NCT03674814 | Completed Phase 1 FDA Drug

• 2 other identifiers: IRB18-0152P50CA180995
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The study is an open-label Phase 1 study of the combination of relacorilant with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC).

Conditions

Prostate Cancer

Keywords

prostate cancer; Enzalutamide; Relacorilant

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  28 days after start of dosing

• Change in steady-state (C-trough) enzalutamide caused by relacorilant

  28 days after start of dosing

Secondary Outcomes (5)

• Preliminary anti-cancer activity of relacorilant as measured by prostate specific antigen levels per response evaluation criteria in solid tumors

  12 weeks after initial start of combination dosing

• Preliminary anti-cancer activity of relacorilant as measured by tumor response per response evaluation criteria in solid tumors

  12 weeks after initial start of combination dosing

• Assess steady state relacorilant drug levels when given with enzalutamide

  28 days after start of dosing

• Assess steady state enzalutamide drug levels when given with relacorilant

  28 days after start of dosing

• Radiographic progression free survival (PFS) of the combination

  Approximately 3 years

Study Arms (1)

Dose Level

EXPERIMENTAL

Relacorilant will be given at a dose once daily. Enzalutamide will be given at a dose once daily.

Drug: Enzalutamide; Drug: Relacorilant

Interventions

Enzalutamide DRUG

Enzalutamide will be taken by mouth at assigned dose. Enzalutamide will be obtained as standard of care prescription (not provided by study).

Also known as: Xtandi(R)

Dose Level

Relacorilant DRUG

Relacorilant will be taken by mouth at assigned dose. Relacorilant will be provided by the study.

Also known as: CORT-125134

Dose Level

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed prostate cancer with documented metastatic disease
• Evidence of castrate testosterone level \<50ng/dl (or surgical castration)
• Evidence of disease progression:
• or more new lesions on bone scan or
• Progressive disease on CT/MRI according to Response Evaluation Criteria in Solid Tumors 1.1 criteria or
• Rising Prostate Specific Antigen (PSA): PSA evidence for progressive prostate cancer consists of a minimum PSA level of at least 2 ng/ml, which has subsequently risen on at least 2 successive occasions, at least 2 weeks apart.
• Prior treatment with at least one line of potent androgen receptor signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide) in either castration-sensitive or castration-resistant setting.
• Any prior therapy for castrate disease is acceptable except prior GR antagonist treatment (e.g. mifepristone or relacorilant).
• Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug.
• Denosumab or zoledronic acid are allowed.
• ECOG performance status ≤ 2.
• Patients must have normal hepatic function as defined below:
• Total bilirubin \</=1.5 x the upper limit of normal
• AST(SGOT)/ALT(SGPT) \</=2.5 X institutional upper limit of normal
• Albumin \>/=3.0 g/dL

You may not qualify if:

• Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid within 2 weeks prior to first dose of study drug.
• a.Patients who have been on systemic corticosteroids with prednisone equivalent of 10mg or greater for greater than 3 months immediately prior to participation in this study must have documented ability to tolerate cessation of corticosteroids prior to enrollment.
• Inability to swallow capsules or known gastrointestinal malabsorption.
• Evidence of visceral disease on imaging in a patient who is an appropriate candidate for cytotoxic chemotherapy (docetaxel or cabazitaxel).
• History of other malignancies, with the exception of: adequately treated non-melanoma skin cancer, adequately treated superficial bladder cancer, stage 1 or 2 malignancies who are without evidence of disease, or other cancers curatively treated with no evidence of disease for \> 5 years from enrollment.
• Blood pressure that is not controlled despite \> 2 oral agents (SBP \>160 and DBP \>90 documented during the screening period with no subsequent blood pressure readings \>160/100).
• History of seizure disorder or active use of anticonvulsants. Medications used to treat neuropathic pain such as gabapentin or pregabalin are allowed.
• Documented history of or current brain metastases due to seizure risk
• Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled.
• Active psychiatric illness/social situations that would limit compliance with protocol requirements.
• NYHA class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure).
• Concurrent therapy with strong inhibitors or inducers of CYP3A4 or CYP2C8 (See Section 9.12below for list of strong inhibitor or inducers) due to concerning possible drug-drug interactions
• Presence of concurrent medical conditions requiring systemic glucocorticoids for immunosuppression (e.g. Autoimmune diseases, organ transplantation) that is active and has required glucocorticoids in the last 6 months.

Sponsors & Collaborators

• University of Chicago: lead
• Corcept Therapeutics: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• Serritella AV, Shevrin D, Heath EI, Wade JL, Martinez E, Anderson A, Schonhoft J, Chu YL, Karrison T, Stadler WM, Szmulewitz RZ. Phase I/II Trial of Enzalutamide and Mifepristone, a Glucocorticoid Receptor Antagonist, for Metastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2022 Apr 14;28(8):1549-1559. doi: 10.1158/1078-0432.CCR-21-4049.

  PMID: 35110415 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide; relacorilant

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Russell Szmulewitz, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be sequentially enrolled to increasing dose escalation cohorts based on safety and PK.

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 18, 2018
• Study Start: October 23, 2018
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)