Phase 1 study of MK-5684 in Japanese Participants with mCRPC
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Registration Number
- JPRN-jRCT2031230431
- Lead Sponsor
- Koh Yasuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 8
Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology and Have received, or been intolerant to, all treatment known to confer clinical benefit.
- Have current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by CT/MRI.
- Have ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nmol/L).
- Participants receiving bone anti-resorptive therapy must have been on stable doses for >=4 weeks prior to the start of study intervention.
- Have progressed on or after treatment with at least 1 line of next generation hormonal agents (NHAs) in metastatic hormone-sensitive prostate cancer (mHSPC) or in 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.
- Have prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening, as determined by the investigator through one of the following:
- PSA progression
- Radiographic disease progression in soft tissue based on RECIST 1.1, with or without PSA progression
- Radiographic disease progression in bone per Prostate Cancer Working Group (PCWG) 3
- Have a performance status of 0 or 1 on the ECOG Performance Scale
- Have a life expectancy of at least 3 months, based on the investigator assessment.
- Have adequate organ function
- A male participant is eligible to participate if he agrees to use contraception during the intervention period and for at least 7 days after the last dose of MK-5684.
- Participants who have AEs due to previous anticancer therapies must have recovered to <=Grade 1 or baseline.
- 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 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 or uncontrolled hypertension.
- Has clinically significant abnormal serum potassium or sodium level.
- Has active or unstable cardio/cerebro-vascular disease, including thromboembolic events.
- 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 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 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.
- Has received other anticancer therapy (excluding LHRH agonists or antagonists) within 4 weeks prior to the start of the study intervention, or immune checkpoint inhibitor within 12 weeks prior to the start of the study intervention.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Dose limiting toxicities<br>- Adverse events(AEs)<br>- Study intervention discontinuation due to an AE
- Secondary Outcome Measures
Name Time Method - Plasma concentration of MK-5684 and derived PK parameters<br>- Prostate specific antigen (PSA)<br>- Time to PSA progression<br>- Radiographic progression-free survival (rPFS)<br>- Objective Response (OR)<br>- Duration of response (DOR)<br>- Overall survival (OS)<br>- Blood concentrations of steroids