A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Pr… (NCT06104449) | Clinical Trial Compass
CompletedPhase 1
A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005)
Japan7 participantsStarted 2023-11-14
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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 met…
What they're measuring
1
Number of Participants Who Experience a Dose-limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 by the Investigator
Timeframe: Up to 28 days
2
Number of Participants Who Experience an Adverse Event (AE)
Timeframe: Up to approximately 24 months
3
Number of Participants Who Discontinue Study Intervention Due to an AE