ISRCTN16103425进行中（未招募）1 期
An open-label, multicenter, 2-arm, phase Ib study to evaluate the pharmacokinetic drug- drug interaction between darolutamide and ipatasertib and the safety of the combination in castration-resistant prostate cancer
Roche (United States) (Genentech, Inc)0 个研究点目标入组 30 人开始时间: 2020年11月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- 性别
- Male
入选标准
- •General Inclusion Criteria:
- •1. Age =18 years
- •2. Eastern Collaborative Oncology Group performance status of 0 or 1 at screening
- •3. Adequate hematologic and organ function
- •4. Ability to comply with the study protocol, per Investigator judgment
- •5. Life expectancy of at least 6 months
- •6. Agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
- •Disease-Specific Inclusion Criteria:
- •7. Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features and has progressed during treatment of at least one hormonal therapy
- •8.Asymptomatic or mildly symptomatic form of prostate cancer
- •9. Progressive disease before initiating study treatment
排除标准
- •General Exclusion Criteria:
- •1. History of malabsorption syndrome or other condition that would interfere with enteral absorption or other impairment of gastrointestinal (GI) function
- •2. Liver cirrhosis, current alcohol abuse, or current known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), or other clinically significant history of liver disease
- •3. Need of more than 10 mg/day of prednisone or an equivalent dose of other corticosteroids as a current systemic corticosteroid therapy to treat a chronic disease
- •4. History of another malignancy within 5 years prior, unless the patient has undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to have a recurrence rate of < 5% at 5 years
- •5. Any other diseases; cardiovascular, pulmonary, or metabolic dysfunction; physical examination finding; or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications
- •Disease-Specific Exclusion Criteria:
- •6. Pathologic findings consistent with small-cell or neuroendocrine carcinoma of the prostate
- •7. Any therapy including chemotherapy or biological therapy for the treatment of CRPC In the case of hormone-sensitive prostate cancer, chemotherapy is permitted provided that it is initiated within 6 months from the time of first castration
- •8. Known untreated or active central nervous system (CNS) metastases
- •9. Use of any medications (only for the first 12 days of Arm 1) that may have the potential to affect heart rate or QTc Interval
- •Darolutamide-Specific Exclusion Criteria:
- •10. Uncontrolled hypertension, recent stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure New York Heart Association (NYHA) Class III or IV
- •11. Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of darolutamide
- •12. Known hypersensitivity to darolutamide or any of its ingredients
- •Ipatasertib-Specific Exclusion Criteria:
- •13. Type 1 or Type 2 diabetes mellitus requiring insulin at study entry
- •14. History of inflammatory bowel disease
- •15. Any ongoing cardiac arrhythmias (including uncontrolled atrial fibrillation) that require medical therapy
- •16. Uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia
- •17. Lung disease
研究者
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