Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dermatologic Agents

Anti-Infective Agents

Dexamethasone

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Dexamethasone acetate

BB 1101

Fludrocortisone

Hydrocortisone-17-butyrate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Participants will receive opevesostat by oral tablets twice daily plus dexamethasone and fludrocortisone by oral tablets once daily continuously until unacceptable toxicity or documented progression. Hydrocortisone will also be provided to participants for use as rescue medication.

Opevesostat

Tablet to be taken orally as a rescue medication.

Toll Free Number

Study Coordinator

Medical Director

The primary objectives of this study are to evaluate the safety and tolerability of opevesostat in the treatment of male Chinese participants with metastatic castration-resistant prostate cancer (mCRPC) and to characterize the pharmacokinetic profile of opevesostat. There are no formal hypotheses to be tested in this study.

A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)

A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in China Participants With Metastatic Castration-Resistant Prostate Cancer

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.

Blood samples will be collected at pre-specified timepoints to determine the Cmax of opevesostat.

Blood samples will be collected at pre-specified timepoints to determine the Tmax of opevesostat.

Blood samples will be collected at pre-specified timepoints to determine the AUC0-12 of opevesostat.

Blood samples will be collected at pre-specified timepoints to determine the Vz/F of opevesostat.

Blood samples will be collected at pre-specified timepoints to determine the CL/F of opevesostat.

Blood samples will be collected at pre-specified timepoints to determine the t1/2 of opevesostat.

The PSA response rate is defined as the percentage of participants in the analysis population with a reduction in PSA level of ≥50% measured twice ≥3 weeks apart.

rPFS is defined as the time from first dose of study intervention to radiographic progression per PCWG-modified RECIST 1.1 as assessed by the investigator OR death due to any cause, whichever occurs first.

ORR is defined as the percentage of participants who have a best overall response of either confirmed Complete Response (CR: disappearance of all target lesions) or a confirmed Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per PCWG-modified RECIST 1.1 as assessed by the investigator.

For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per PCWG-modified RECIST 1.1, DOR is defined as the time from first documented evidence of confirmed CR or PR until disease progression or death from any cause, whichever occurs first.

OS is defined as time from first dose of study intervention to death due to any cause.

Blood samples collected at multiple timepoints after the administration of opevesostat will be used to determine the blood concentrations of steroids.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)	NCT06136598	Prostatic Neopl... Metastatic Cast...	Opevesostat Dexamethasone Fludrocortisone Hydrocortisone	18 Years -	Merck Sharp & Dohme LLC
A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)	NCT06136598	Prostatic Neopl... Metastatic Cast...	Opevesostat Dexamethasone Fludrocortisone Hydrocortisone	18 Years -	Merck Sharp & Dohme LLC

Spots Global Cancer Trial Database for fludrocortisone