NCT07723248招募中3 期
A Phase 3, Randomized, Open-Label Study of Rinzimetostat (ORIC-944) in Combination With Darolutamide Compared With ARPI or Docetaxel in Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Abiraterone Acetate (Himalayas-1)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 7
- 主要终点
- Radiographic Progression Free Survival assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
研究概览
简要总结
Himalayas-1 is a randomized, open-label, global, multicenter phase 3 study evaluating whether the combination of rinzimetostat with darolutamide is more effective compared to physician's choice of control; ARPI (darolutamide or enzalutamide) or docetaxel for treating patients with metastatic castration resistant prostate cancer (mCRPC) who were previously treated with abiraterone acetate.
The primary objective of this study is to demonstrate superiority in radiographic progression free survival (rPFS) of the investigational arm of rinzimetostat + darolutamide combination versus physician's choice of control: ARPI (darolutamide or enzalutamide) or docetaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features
- •Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required
- •Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ function
排除标准
- •Prior treatment for prostate cancer at any stage with cytotoxic chemotherapy, radioligand therapy (ie, 177Lu -PSMA-617, radium-223), ARPIs including apalutamide, darolutamide, and enzalutamide, PARP monotherapy or other systemic anticancer treatment (approved drugs or experimental compounds such as, antibody therapy, immunotherapy, gene or cell therapy, angiogenesis inhibitors, CDK4/6 inhibitors, PRC2 inhibitors) with the following exceptions:
- •Treatment with first-generation antiandrogen agents (eg, bicalutamide, flutamide, nilutamide), but must be discontinued prior to the first dose of study medication
- •Docetaxel treatment is allowed for mCSPC, as long as no signs of failure or disease progression occurred during treatment or within 3 months of treatment completion
- •Any other anticancer therapy (drug or vaccine which does not meet exclusion criterion 1 above) within 28 days or 5 half-lives (whichever is longer) prior to randomization
- •Known or suspected brain metastasis or active leptomeningeal disease
- •Clinically significant cardiovascular disease defined as:
- •Any medical (including active or clinically significant bacterial, fungal, or viral infection) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the patient inappropriate for the study
- •Active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery are excluded
研究组 & 干预措施
Physician's Choice
Active Comparator
Control Arm
干预措施: Darolutamide (Drug)
Physician's Choice
Active Comparator
Control Arm
干预措施: Docetaxel (Drug)
Physician's Choice
Active Comparator
Control Arm
干预措施: Enzalutamide (Drug)
Investigational Arm
Active Comparator
Rinzimetostat + darolutamide
干预措施: Darolutamide (Drug)
Investigational Arm
Active Comparator
Rinzimetostat + darolutamide
干预措施: Rinzimetostat (Drug)
结局指标
主要结局
Radiographic Progression Free Survival assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
时间窗: Randomization up to ~2 years
Radiographic Progression Free Survival is defined as the time from the date of randomization to first evidence of radiographic progression as assessed in soft tissue by RECIST 1.1 or in bone per PCWG3 guideline by BICR, or death, whichever occurs first
次要结局
- Overall Survival (OS)(5 years)
- Objective response rate (ORR)(Randomization up to ~2 years)
- Duration of Response (DoR)(Randomization up to ~2 years)
- Prostate Specific Antigen (PSA) response(Randomization up to ~2 years)
- Time to PSA progression(Randomization up to ~2 years)
- Time to initiation of antineoplastic therapy(Randomization up to ~4 years)
- Time to first symptomatic skeletal event(Randomization up to ~4 years)
- Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF)(Randomization up to ~4 years)
- Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P)(Randomization up to ~4 years)
- Change from baseline in social/family well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)(Randomization up to ~4 years)
- Change from baseline in functioning well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)(Randomization up to ~4 years)
- Change from baseline in physical well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)(Randomization up to ~4 years)
- Change from baseline in symptoms per Functional Assessment of Cancer Therapy - Prostate (FACT-P)(Randomization up to ~4 years)
- Change from baseline in patient reported health status per European Quality of Life 5-Dimension 5 Level (EQ-5D-5L)(Randomization up to ~4 years)
- Symptomatic toxicity as measured by items from the Patient-Reported Outcome CTCAE (PRO-CTCAE)(Randomization up to ~2 years)
- Overall side effect burden as measured by the FACT- GP5(Randomization up to ~2 years)
- Time to confirmatory deterioration in patient-reported pain symptoms per BPI-SF Item 3 "worst pain in 24 hours"(Randomization up to ~4 years)
- Time to definitive deterioration in patient-reported health related quality of life (HRQoL) per FACT-P(Randomization up to ~4 years)
- Time to definitive deterioration in patient-reported physical well-being per FACT-P(Randomization up to ~4 years)
- Incidence of Adverse Events (AEs)(Randomization up to ~2 years)
- Evaluate the pharmacokinetics (PK) of rinzimetostat in combination with darolutamide(Randomization up to ~1 year)
研究者
研究点 (7)
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