A Master Protocol Evaluating the Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) -

AMGEN INC.0 个研究点目标入组 105 人开始时间: 2021年6月8日最近更新: 2023年1月9日

适应症

试验速览

暂无简介。

•All Subprotocols
•- Subjects with mCRPC with histologically or cytologically confirmed adenocarcinoma of the prostate without pure neuroendocrine differentiation or small cell features
•- Subjects should have undergone bilateral orchiectomy or should be on continuous androgen deprivation therapy with a gonadotropin releasing hormone agonist or antagonist
•- Total serum testosterone should be <= 50 ng/dL (or 1.7 nmol/L)
•- Eastern Cooperative Oncology Group (ECOG) performance status of 0 – 1
•- Life expectancy of > 3 months
•*Please refer to protocol for the full list
•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 53
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 52

•All Subprotocols
•- Pathological finding consistent with pure small cell, neuroendocrine carcinoma of the prostate or any other histology different from adenocarcinoma
•- CNS metastases or leptomeningeal disease
•- Symptomatic peripheral sensory or motor neuropathy >= grade 3
•- History or presence of clinically relevant CNS pathology
•- Confirmed history/current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy
•- Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials (Subprotocol A&B) / active fungal, bacterial, viral, or other infection requiring systemic therapy (Subprotocol C) within 7 days of dosing
•- History/evidence of inflammatory bowel disease or any other GI disorder causing chronic nausea, vomiting, or diarrhea
•- History of arterial or venous thrombosis within 12 months of first dose
•- Myocardial infarction, uncontrolled hypertension (Subprotocol A&C), unstable angina, cardiac arrhythmia requiring medication, and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months (Subprotocol A&B) / within 6 months (Subprotocol C) of first dose of AMG 160
•*Please refer to protocol for the full list

发起方

AMGEN INC.