CompletedPhase 1

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

United States42 participantsStarted 2018-10-23

Plain-language 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).

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Histologically or cytologically confirmed prostate cancer with documented metastatic disease
✓. Evidence of castrate testosterone level \<50ng/dl (or surgical castration)
✓. Evidence of disease progression:
✓. 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.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

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

Timeframe: 28 days after start of dosing

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

Timeframe: 28 days after start of dosing

Trial details

NCT IDNCT03674814

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-10

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