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Trial Title:
A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)
NCT ID:
NCT06136598
Condition:
Prostatic Neoplasms
Metastatic Castration-Resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Dexamethasone
Dexamethasone acetate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Fludrocortisone
BB 1101
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:
Dexamethasone acetate
Intervention type:
Drug
Intervention name:
Fludrocortisone
Description:
Tablets to be taken orally.
Arm group label:
Opevesostat
Other name:
Fludrocortisone acetate
Intervention type:
Drug
Intervention name:
Hydrocortisone
Description:
Tablet to be taken orally as a rescue medication.
Arm group label:
Opevesostat
Other name:
Hydrocortisone acetate
Summary:
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.
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 prostate cancer while receiving androgen deprivation therapy (ADT), or
post-bilateral orchiectomy, within 6 months before screening.
- Has evidence of progression >4 weeks since last flutamide treatment or >6 weeks
since last bicalutamide or nilutamide treatment.
- Has evidence of metastatic disease documented by either bone lesions on bone scan
and/or soft tissue shown by CT/MRI.
- Has disease that progressed during or after treatment with at least 1 line of
next-generation hormonal agents (NHAs) for hormone-sensitive prostate cancer (HSPC)
or castration-resistant prostate cancer (CRPC) for at least 8 weeks (at least 14
weeks for participants with bone progression).
- Has received at least 1 line of taxane-based chemotherapy for HSPC or CRPC and have
had progressed disease during or on treatment, or refused or ineligible to receive
chemotherapy.
- Has a life expectancy of >3 months.
Exclusion Criteria:
- Has history of a second malignancy, unless potentially curative treatment has been
completed with no evidence of malignancy for 3 years.
- Has presence of gastrointestinal condition, e.g. malabsorption, that might affect
the adsorption of study intervention.
- Has a history of pituitary dysfunction.
- Has poorly controlled diabetes mellitus.
- Has active or unstable cardio/cerebro-vascular disease, including thromboembolic
events.
- Has undergone major surgery, including local prostate intervention (except prostate
biopsy), within 4 weeks of the date of allocation.
- Has received an anticancer monoclonal antibody (mAb) within 4 weeks of allocation,
or has not recovered from adverse events (AEs) due to mAbs administered more than 4
weeks before the date of allocation.
- Received prior systemic anticancer therapy including investigational agents within 4
weeks before the date of allocation.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any form of
immunosuppressive therapy within 7 days prior to the start of study intervention.
- Has a known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.
- Has an active autoimmune disease that has required systemic treatment in the past 2
years.
- Has a history of or current human immunodeficiency virus (HIV) infection.
- Has a concurrent Hepatitis B or Hepatitis C virus infection.
- Has a history of allogenic tissue or solid organ transplant.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University First Hospital-Urology ( Site 0001)
Address:
City:
Beijing
Zip:
100034
Country:
China
Facility:
Name:
Sun Yat-sen University Cancer Center-Neurosurgery department ( Site 0003)
Address:
City:
Guangzhou
Zip:
510700
Country:
China
Facility:
Name:
Tongji Hospital Tongji Medical,Science & Technology ( Site 0002)
Address:
City:
Wuhan
Zip:
430000
Country:
China
Start date:
January 30, 2024
Completion date:
March 14, 2027
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/NCT06136598
http://www.merckclinicaltrials.com
