PER-048-23尚未招募3 期
A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)0 个研究点目标入组 0 人开始时间: 2024年6月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Type of Participant and Disease Characteristics: Have histologically or cytologically confirmed (if acceptable according to local health authority regulations) adenocarcinoma of the prostate without small cell histology. The diagnosis must be stated in a pathology report and confirmed by the investigator.
- •Type of Participant and Disease Characteristics: Have prostate cancer progression while receiving ADT (or post bilateral orchiectomy) within 6 months before Screening. Prostate cancer progression will be determined by the investigator, defined as 1 of the following:
- •-PSA progression shown by local laboratory values, as defined by a minimum of 2 consecutive rising PSA levels with an interval of =1 week between each assessment, where PSA at screening should be =1 ng/mL. Refer to Section 8.2.2 for further details.
- •Note: A PSA level obtained during the screening period can count as the confirmatory second rising PSA.
- •-Radiographic disease progression in soft tissue based on RECIST 1.1, with or without PSA progression.
- •-Radiographic disease progression in bone per PCWG, defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression.
- •Type of Participant and Disease Characteristics: Have disease progression under the following conditions if the participant received first generation anti-androgen therapy before screening:
- •- Evidence of progression >4 weeks since the last flutamide treatment.
- •- Evidence of progression >6 weeks since the last bicalutamide or nilutamide treatment.
- •Type of Participant and Disease Characteristics: Have current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease shown by CT/MRI.
- •Type of Participant and Disease Characteristics: Have disease that progressed during or after treatment with 1 NHA (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide) for nmHSPC, nmCRPC, mHSPC, or mCRPC for at least 8 weeks (at least 14 weeks for participants with bone progression).
- •Participants that received NHA for nmHSPC, nmCRPC, mHSPC, mCRPC may not have received another NHA treatment before enrollment.
- •Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for nmHSPC, mHSPC, or nmCRPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel.
- •Type of Participant and Disease Characteristics: Have received 1 but no more than 2 taxane-based chemotherapy regimens for mCRPC and have had PD during or after treatment. If docetaxel chemotherapy has been used more than once (eg, once for mHSPC and once for mCRPC), it will be considered as 1 taxane-based chemotherapy for mCRPC. Prior docetaxel and/or cabazitaxel for mCRPC is allowed if =4 weeks have elapsed from the last dose of most recent t
排除标准
- •Medical Conditions: Clinically significant abnormal serum potassium or sodium level.
- •Medical Conditions: History of pituitary dysfunction.
- •Note: Exceptions may be considered after Sponsor consultation.
- •Medical Conditions: Poorly controlled diabetes mellitus.
- •Medical Conditions: Has presence of gastrointestinal condition, eg, malabsorption, that might affect the absorption of study medication.
- •Medical Conditions: Is unable to swallow capsules/tablets.
- •Medical Conditions: Has any of the following at Screening Visit:
- •- Hypotension: systolic BP <110 mm Hg.
- •- Uncontrolled hypertension: systolic BP =160 mm Hg or diastolic BP =90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy.
- •Medical Conditions: Has active or unstable cardio/cerebro-vascular disease, including thromboembolic events.
- •Examples: recent (within 6 months) myocardial infarction, coronary artery bypass graft or symptomatic cerebrovascular accident or congestive heart failure (New York Heart Association Class III-IV).
- •Medical Conditions: History or family history of long QTc syndrome.
- •Medical Conditions: Has a resting ECG indicating uncontrolled, potentially reversible cardiac conditions as judged by the investigator (eg, unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >470 msec, electrolyte disturbances, etc), or has congenital long QT syndrome.
- •Medical Conditions: Has a history of seizure(s) within 6 months of providing documented informed consent or
- •has any condition that may predispose to seizures within 12 months before the date of randomization including but not limited to loss of consciousness or prior cerebrovascular accident, transient ischemic attack, or brain arteriovenous malformation, or intracranial masses such as a schwannoma or meningioma that is causing edema or mass effect.
研究者
相似试验
招募中
1 期
A clinical trial comparing a new treatment (MK-5684) to approved medication for advanced prostate cancer after prior hormonal therapy and chemotherapyMetastatic castration resistant prostate cancerMedDRA version: 21.1Level: LLTClassification code: 10076506Term: Castration-resistant prostate cancer Class: 10029104CTIS2023-504899-25-00Merck Sharp & Dohme LLC1,246
招募中
1 期
A clinical trial comparing a new treatment (MK-5684) to approved medication for advanced prostate cancer after prior hormonal therapyMetastatic castration resistant prostate cancerMedDRA version: 21.1Level: LLTClassification code: 10076506Term: Castration-resistant prostate cancer Class: 10029104CTIS2023-504957-11-00Merck Sharp & Dohme LLC1,476
尚未招募
3 期
Phase 3 Study of MK-5684 Versus Alternative Treatment with an NHA in mCRPC After Treatment with an NHAD075 ProstateProstateD075PER-047-23Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
进行中（未招募）
1 期
An Open-label, Randomized Phase 3 Study of MK-6482 versus Everolimus in Participants with Advanced Renal Cell Carcinoma that has Progressed After Prior TherapyAdvanced Renal Cell CarcinomaMedDRA version: 21.1Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-003444-72-ESMerck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc736
进行中（未招募）
1 期
An Open-label, Randomized Phase 3 Study of MK-6482 versus Everolimus in Participants with Advanced Renal Cell Carcinoma that has Progressed After Prior TherapyAdvanced Renal Cell CarcinomaMedDRA version: 21.1Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-003444-72-FRMerck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc736