NL-OMON54909撤回不适用
A Master Protocol Evaluating the Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC);-Subprotocol A: A Phase 1b Study Evaluating the Safety and Efficacy of AMG 160 in Combination With Enzalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC) -Subprotocol B: A Phase 1b Study Evaluating the Safety and Efficacy of AMG 160 in Combination With Abiraterone in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC) - 20190505 AMG 160 combination therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Amgen
- 入组人数
- 6
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Subject has provided informed consent prior to initiation of any study
- •specific activities/procedures.
- •- Age * 18 years at the time of signing the informed consent.
- •- 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
- •- Adequate organ function, defined as follows:
- •* absolute neutrophil count * 1.5 x 10^9/L (without growth factor support
- •within 7 days from screening assessment)
- •* platelet count * 100 x 10^9/L (without platelet transfusion within 7 days
- •from screening assessment)
- •* hemoglobin > 9 g/dL (90 g/L) (subprotocol A) / > 10 g/dL (100g/L)
- •(subprotocol B) (without blood transfusion within 7 days from screening
- •assessment)
- •* estimated glomerular filtration rate based on Modification of Diet in Renal
- •Disease (MDRD) calculation * 30 mL/min/1.73 m2
- •* AST and ALT < 3 x upper limit of normal (ULN) (or < 5 x ULN for subjects with
- •liver involvement)
- •* total bilirubin (TBL) < 1.5 x ULN (or < 2 x ULN for subjects with liver
- •metastases)
- •* left ventricular ejection fraction (LVEF) > 50% (2-D transthoracic
- •echocardiogram [ECHO] is the preferred method of evaluation; multi-gated
- •acquisition scan is acceptable if ECHO is not available)
- •- Baseline electrocardiogram (ECG) QTc * 470 msec
- •- Subjects planning to receive enzalutamide (subprotocol A) / abiraterone
- •(subprotocol B) for the first time for mCRPC (subjects who received prior
- •enzalutamide (subprotocol A) / abiraterone (subprotocol B) are not eligible).
排除标准
- •Applicable for both 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 within 7 days of dosing
- •- History/evidence of inflammatory bowel disease or any other gastrointestinal
- •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), unstable
- •angina, cardiac arrhythmia requiring medication, and/or symptomatic congestive
- •heart failure (New York Heart Association > class II) within 12 months of first
- •dose of AMG 160
- •- Unresolved toxicities from prior anti-tumor therapy not having resolved to
- •CTCAE version 5.0 grade 1, with the exception of alopecia or toxicities that
- •are stable and well-controlled AND there is agreement to allow by both the
- •investigator and sponsor
- •- Known HIV infection, hepatitis C or hepatitis B infection
- •- History of other malignancy within the past 2 years, with the following
- •exceptions:
- •* Malignancy treated with curative intent and with no known active disease
- •present for * 3 years before enrollment and felt to be at low risk for
- •recurrence by the treating physician.
- •* Adequately treated non-melanoma skin cancer or lentigo maligna without
- •evidence of disease.
- •* Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in
- •- Prior treatment with a taxane for mCRPC.
- •- Radiation therapy within 4 weeks of first dose (or local or focal
- •radiotherapy within 2 weeks)
- •- Any anticancer therapy or immunotherapy within 4 weeks of start of first
- •dose, not including LHRH/GnRH analogue. Subjects on a stable bisphosphonate or
- •denosumab regimen for * 30 days prior to enrollment are eligible
- •- Prior PSMAxCD3 bispecific therapy
- •- Requiring chronic systemic corticosteroid therapy or any other
- •immunosuppressive therapies. Low dose corticosteroids permitted.
- •- Prior major surgery within 4 weeks of first dose
- •- Currently receiving treatment in another investigational device or drug
- •study, or less than 4 weeks since ending treatment on another investigational
- •device or drug study(ies).
- •- Male subjects with a female partner of childbearing potential or pregnant
- •partner who are unwilling to practice sexual abstinence or use contraception
- •during treatment and for an additional 4 months after the last dose
- •- Male subjects unwilling to abstain from donating sperm during treatment and
- •for an additional 4 months after the last dose.
- •- Subject has known sensitivity to any of the products (or components) to be
- •administered during dosing.
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