A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005)

Trial Title: A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005)

NCT ID: NCT06104449

Condition: Prostatic Neoplasms
Metastatic Castration-Resistant Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms
Dexamethasone
Hydrocortisone
Fludrocortisone

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Opevesostat
Description: Tablets to be taken orally.
Arm group label: Opevesostat

Other name: MK-5684

Intervention type: Drug
Intervention name: Dexamethasone
Description: Tablets to be taken orally.
Arm group label: Opevesostat

Other name: Decadron

Intervention type: Drug
Intervention name: Fludrocortisone acetate
Description: Tablet to be taken orally.
Arm group label: Opevesostat

Intervention type: Drug
Intervention name: Hydrocortisone
Description: Tablets to be taken orally as a recue medication.
Arm group label: Opevesostat

Summary: The purpose of this study is to assess the efficacy and safety of opevesostat in the treatment of Japanese men with metastatic castration-resistant prostate cancer (mCRPC) previously treated with Next Generation Hormonal Agent (NHA) and taxane-based chemotherapy.

Criteria for eligibility:
Criteria:
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: - Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology - Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI) - Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nmol/L) - Participants receiving bone anti-resorptive therapy (including, but not limited to bisphosphonate or denosumab) must have been on stable doses for ≥4 weeks prior to the start of study intervention. - Has progressed on or after treatment with at least 1 line of NHAs in metastatic hormone-sensitive prostate cancer (mHSPC) or in castration-resistant prostate cancer (CRPC) for a minimum of 12 weeks (e.g. abiraterone, enzalutamide, darolutamide, apalutamide), and with at least 1 line of taxane-based chemotherapy in mHSPC or in CRPC, or ineligibility for chemotherapy - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to allocation - If capable of producing sperm, participant must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat: Refrain from donating sperm, plus EITHER be abstinent OR must agree to use male condom. Exclusion Criteria: - Has a history of pituitary dysfunction - Has brain metastases - History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years - Has an active or uncontrolled autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) - Has an active infection or other medical condition that would make corticosteroid contraindicated - Has serious persistent infection within 2 weeks prior to the start of the study intervention - Participants on an unstable dose of thyroid hormone therapy within 6 months prior to the start of the study intervention - Has poorly controlled diabetes mellitus - Hypotension: systolic blood pressure (BP) < 110 mmHg, or uncontrolled hypertension: systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg, in 2 out of 3 recordings with optimized antihypertensive therapy - Has active or unstable cardio/cerebro-vascular disease, including thromboembolic event - Is unable to swallow orally administered medication or known gastrointestinal (GI) disease or GI procedure that may interfere with absorption of study intervention - Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to the start of the study intervention and not adequately recovered from the toxicities and/or complications - Has received aldosterone antagonist (e.g. spironolactone, eplerenone) and phenytoin within 4 weeks prior to the start of the study intervention - Has received radiotherapy within 4 weeks prior to the start of the study intervention, or radiation related toxicities, requiring corticosteroids - Has received chemotherapy within the last 4 weeks (2 weeks for oral or weekly chemotherapy; 6 weeks for nitrosoureas and mitomycin C) prior to the start of the study intervention - Has received prior enzalutamide and apalutamide within 3 weeks, or abiraterone and darolutamide within 2 weeks prior to the start of the study intervention - Systemic use of the following medications within 2 weeks prior to the start of study intervention: strong cytochrome P450 (CYP)3A4 inducers: e.g., carbamazepine, rifampicin, phenobarbital, phenytoin, St John's Wort) and strong CYP3A4 inhibitors: e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, grapefruit juice - Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. - Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (eg, saw palmetto) within 4 weeks prior to the start of the study intervention - Has received treatment with 5-α reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to the start of the study intervention - Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration - History of human immunodeficiency virus (HIV) infection - Has a history of Hepatitis B or active Hepatitis C virus - Has a "superscan" bone scan - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the start of the study intervention

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: National Cancer Center Hospital East ( Site 0001)

Address:
City: Kashiwa
Zip: 277-8577
Country: Japan

Facility:
Name: Toho University Sakura Medical Center ( Site 0003)

Address:
City: Sakura
Zip: 285-8741
Country: Japan

Facility:
Name: Yokohama City University Medical Center ( Site 0002)

Address:
City: Yokohama
Zip: 232-0024
Country: Japan

Start date: November 14, 2023

Completion date: January 12, 2026

Lead sponsor:
Agency: Merck Sharp & Dohme LLC
Agency class: Industry

Collaborator:
Agency: Orion Corporation, Orion Pharma
Agency class: Industry

Source: Merck Sharp & Dohme LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06104449
http://www.merckclinicaltrials.com