ARMOR2: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 126
- 试验地点
- 23
- 主要终点
- Confirmation of recommended dose and patient population for Part 2 of the study.
研究概览
简要总结
A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration resistant prostate cancer (CRPC) patients.
详细描述
This trial will be split into two parts. The purpose of Part 1 will be to confirm dose and target patient population and Part 2 will be expansion of the dose and patient population selected in Part 1. For eligible patients, there will be an optional extension dosing following the completion of Part 1 or Part 2 of the trial.
Obtaining of informed consent and screening may be performed up to 28 days prior to enrollment. Each patient will be able to receive his specified regimen for 3 consecutive cycles. Each cycle consists of 28 days (approximately 1 mo.). End of Cycle 3 visit assessments will be used to determine outcome and dosing may continue up to an additional 2 weeks until the results of all assessments are obtained. Eligible patients may continue treatment in an optional extension period following the completion of the primary parts of this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Ongoing androgen blockade demonstrated by serum testosterone concentration of less than 50 ng/dL
- •Demonstration of progression while on androgen blockade
- •Eastern Cooperative Oncology Group (ECOG) Performance Status <2
排除标准
- •Depending upon patient prior treatment the following apply:
- •Prior treatment with CYP17 inhibitors or AR antagonists (e.g. abiraterone, TAK-700, ARN-509, ketoconazole*, enzalutamide, or galeterone) - Treatment naïve only
- •Prior treatment with CYP17 inhibitors (e.g. TAK-700, ketoconazole*) or AR antagonists (e.g. enzalutamide, ARN-509,) or galeterone - abiraterone refractory only
- •Prior treatment with CYP17 inhibitors (e.g. abiraterone, TAK-700, ketoconazole*) or AR antagonists (e.g. ARN -509) or galeterone - enzalutamide refractory only
- •Prior chemotherapy (unless allowed for some study arms)
- •Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment
- •Prior use of any chronic systemic glucocorticoids .
- •Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment
- •Prior treatment with Alpharadin® (Xofigo®)
- •Treatment with anti arrhythmia therapy for ventricular arrhythmia < 4 weeks prior to enrollment
- •Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) < 4 weeks prior to enrollment
- •Severe systemic diseases or active uncontrolled illnesses.
- •Abnormal heart function
- •Liver metastases
- •Brain metastases (unless stable disease >3 mos. by scan without additional CNS-directed therapy)
- •The patient has known allergy to any of the treatment components
- •Any physical or mental condition or social situation that in the opinion of the Investigator may interfere with the patient's ability to comply with the trial procedures
- •History of excessive alcohol consumption
- •Use of any substance known to cause AME
研究组 & 干预措施
Dose Confirmation
Dose A - galeterone tablets once daily PO for three months + extension
Dose B - galeterone tablets once daily PO for three months + extension
Dose C - galeterone tablets once daily PO for three months + extension
干预措施: galeterone (Drug)
Dose Expansion
Single dose expansion (from part 1) of galeterone tablets once daily PO for three months + extension
干预措施: galeterone (Drug)
结局指标
主要结局
Confirmation of recommended dose and patient population for Part 2 of the study.
时间窗: 3 months
Confirmation of recommended dose and patient population for Part 2 of the study.
Assessment of efficacy by means of PSA response.
时间窗: 3 months
Assessment of efficacy by means of PSA response.
次要结局
未报告次要终点