EUCTR2017-000160-15-IT进行中（未招募）1 期
HERO - MVT -601-3201: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men with Advanced Prostate Cancer - HERO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Has voluntarily signed and dated the informed consent form prior to initiation of any screening or study-specific procedures; 2. Is a male aged 18 years or older on the day of signing and dating the informed consent form; 3. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate; 4. Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with one of the following clinical disease state presentations:
- •a. Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound and not a candidate for salvage treatment by surgery (radiotherapy, cryotherapy, or high frequency ultrasound are allowed after 2 months of androgen deprivation therapy); or b. Newly diagnosed androgen-sensitive metastatic disease; or c. Advanced localized disease unlikely to be cured by local primary surgical intervention with either surgery or radiation with curative intent (radiotherapy, cryotherapy, or high frequency ultrasound are allowed after 2 months of androgen deprivation therapy); 5. Has a serum testosterone at the Screening visit of = 150 ng/dL (1.5 ng/mL or 5.2 nmol/L); 6. Has a serum PSA concentration at the Screening visit of > 2.0 ng/mL (2.0 µg/L), or, when applicable, post radical prostatectomy of > 0.2 ng/mL (0.2 µg/L) or post radiotherapy, cryotherapy, or high frequency ultrasound > 2.0 ng/mL (2.0 µg/L) above the post interventional nadir; 7. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at initial screening and at baseline (refer to Appendix 1); 8. Is a male patient who, even if surgically sterilized (ie, status post vasectomy): a. Agrees to use a male condom if having sex with a woman of childbearing potential age or a pregnant woman, during the entire study Treatment Period and through 4 months after the last dose of study drug; or b. Agrees to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods for the female partner) and withdrawal are not acceptable methods of contraception; 9. Must agree not to donate sperm from first dose of study drug through 4 months after the last dose of study drug; 10. A randomization authorization form has been signed by a study medical monitor approving the patient for randomization into the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 550
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 550
排除标准
- •1. In the investigator's opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy; 2. Previously received GnRH analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for > 18 months total duration. If androgen deprivation therapy was received for = 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline; If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot.
- •3. Previous system treatment for prostate cancer with a taxane-based regimen; 4. Metastases to brain per prior clinical evaluation; 5. Scheduled for major surgery after baseline; 6. History of surgical castration; 7. residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. Patients with Stage 0 or Stage 1 melanoma or superficial Stage 0 or Stage 1 bladder cancer, if curatively managed prior to screening, are not excluded. The medical monitor should be contacted for any questions regarding this exclusion criterion; 9. Abnormal laboratory values at the Screening visit that suggest a clinically unstable underlying disease, or the following laboratory values: a. Serum gamma-glutamyl transferase > 2.0 x upper limit of normal (ULN); b. Serum ALT and/or AST > 1.0 x ULN; c. Total Bil. > 1.0 x ULN (unless secondary to Gilbert's syndrome or the pattern is consistent with a diagnosis of Gilbert's syndrome) or; d. Serum creatinine > 2.0 mg/dL; 10. Uncontrolled diabetes with HbA1c > 10% or previously undiagnosed diabetes mellitus with screening HbA1c > 8% (such excluded patients may be rescreened after referral and evidence of improved control of their condition);
- •11. Has jaundice or known current active liver disease from any cause, including hep. A (hep. A virus IgM positive), hep. B (hep. B virus surface antigen [HBsAg] positive), or hep. C (hep. C virus [HCV] antibody positive, confirmed by HCV ribonucleic acid); 12. Known human HIV infection;
- •13. Within 6 months before baseline, a history of myocardial infarction, angina, unstable symptomatic ischemic heart disease, or congestive heart failure, or any history of clinically significant ventricular arrhythmias such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes, or history of Mobitz II second degree or third degree heart block without permanent pacemaker in place or untreated supraventricular tachycardia (heart rate = 120 beats per minute); thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events); or any other significant cardiac condition (eg, pericardial effusion, restrictive cardiomyopathy). Patients with chronic stable atrial fibrillation on stable anticoagulant therapy or patients with stable cardiac rhythm controlled by a pacemaker are allowed; 14. The following ECG abnormalities are excluded: a. Q-wave infarction, unless identified 6 or more months before the Screening visit; b. QT interval corrected for heart rate (QTc) > 470 msec. If the QTc is prolonged in a patient with a pacemaker, the patient may be enrolled in the study upon discussion with the medical monitor; or c. Congenital long QT syndrome; 15. Uncontrolled hypertension despite
研究者
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