EUCTR2016-002057-38-GB进行中（未招募）1 期
A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 289
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
- •2. >18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
- •3. Signed main study ICF indicating that the subject understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •4. Histologically confirmed prostate cancer (mixed histology is acceptable,with the exception of the small cell pure phenotype, which to be excluded).
- •5.3. Criterion modified per Amendment 6
- •5.4. Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer with evidence of disease progression on or after treatment, or discontinued from a taxane-based chemotherapy due to an adverse event
- •6.4. Criterion modified per Amendment 7.
- •6.5. Received a second-generation or later AR-targeted therapy (for example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the treatment of metastatic prostate cancer with evidence of disease progression or non-metastatic castration-resistant prostate cancer with evidence of subsequent metastasis.
- •7.1. Criterion modified per Amendment 7
- •7.2 Biomarker-positive by at least one of the following criteria:
- •a. Biallelic DNA-repair anomaly (refer to Table 5) based on a sponsor-validated blood or tissue assay.
- •b. Germline pathogenic BRCA1 or BRCA2 by any test (somatic local results must be confirmed as positive by the sponsor-validated assay before dosing).
- •8. Progression of metastatic prostate cancer in the setting of castrate levels of testosterone =50 ng/dL on a gonadotropin releasing hormone analog (GnRHa), or history of bilateral orchiectomy at study entry defined as having one or more of the following:
- •a. PSA progression defined by a minimum of 2 rising PSA levels with an interval of =1 week between each determination (per Prostate Cancer Working Group 3 [PCWG3] criteria). The PSA level at the screening visit should be =1 µg/L (1 ng/mL).
- •b. Radiographic progression of soft tissue by RECIST 1.1 or bone disease by PCWG3 criteria as defined below:
- •I. Soft disease (measurable) by RECIST 1.1 defined as having one or more of the following:
- •i. Nodal disease (pelvic or extrapelvic [retroperitoneal, mediastinal, thoracic, other]) with lesions =1.5 cm in the short axis.
- •ii. Visceral disease (lung, liver, adrenal) with lesions =1 in the long axis.
- •II. Bone disease (non-measurable) defined as having bone lesions in the absence of measurable soft tissue disease
- •9. Must be able to continue GnRHa during the course of the study if not surgically castrate.
- •10. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of =2.
- •11. Must be able to swallow whole capsules.
- •12. Subject must agree to use medically accepted and highly effective methods of contraception during the course of the study and for 3 months after the last dose of study drug.
- •13. To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must agree while on study drug and for 3 months following the last dose of study drug to:
- •a. Use a condom during sexual activity.
- •b. Not donate sperm.
- •14.3. Criterion modified per Amendment 6
- •14.4. At screening,the following laboratory parameters must be met:
- •a. Absolute neutrophil count (ANC) =1.5 x 10^9/L
- •b. Hemoglobin =9.0 g/dL
- •c. Platelet count =100 x 10^9/L
- •d. Serum albumin =3 g/dL
- •e. Creatinine clearance =30 mL/min
- •f. Criterion deleted per Amendment 5.
- •g. Serum total bilirubin =1.5 x upper limit of normal (ULN) or direct bilirubin =1 x ULN (Note: in subjects with Gilber
排除标准
- •1. Prior treatment with a PARP inhibitor.
- •2. Prior platinum-based chemotherapy for the treatment of prostrate cancer.
- •3. Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
- •4. Symptomatic or impending cord compression, except if subject has received definitive treatment for this and demonstrates evidence of clinically stable disease.
- •5. Symptomatic brain metastases.
- •6. Known allergies, hypersensitivity, or intolerance to niraparib or its excipients (refer to Investigator's Brochure).
- •7. Any condition for which, in the opinion of the investigator or sponsor, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •8. Known disorder affecting gastrointestinal absorption.
- •9. Active cancer (other than prostate cancer; or basal cell or squamous cell skin cancer, non-muscle invasive bladder cancer [stages pTaG1 and pTaG2], or any other cancer in situ currently in complete remission) within 2 years prior to Cycle 1 Day 1.
- •10.Prior palliative radiotherapy =7 days prior to Cycle 1 Day 1 Radiotherapy given >7 days prior to Cycle 1 Day 1 is permitted as long as any AEs associated with radiotherapy have resolved to Grade 1 or
- •11. Criterion deleted per Amendment 5
- •12. Criterion deleted per Amendment 3.
- •13. History of clinically significant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, torsades de pointes).
- •14. HIV positive subjects with 1 or more of the following:
- •a. Not receiving highly active antiretroviral therapy
- •b. A change in antiretroviral therapy within 6 months of the start of screening(except if, after consultation with the sponsor on exclusion criterion 14.c, a change is made to avoid a potential drug-drug interaction with the study drug)
- •c. Receiving antiretroviral therapy that may interfere with the study drug consult the sponsor for review of medication prior to enrollment)
- •d. CD4 count <350 at screening
- •e. An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening
- •15.1. Criterion modified per Amendment 6.
- •15.1. =14 days prior to Cycle 1 Day 1 had:
- •a. a transfusion (platelets or red blood cells)
- •b. chemotherapy
- •c. hematopoietic growth factors
- •16. Criterion deleted per Amendment 5.
- •17. Subjects with uncontrolled (persistent) hypertension defined as systolic blood pressure =160 mm Hg or diastolic blood pressure =100 mm Hg despite medical management.
研究者
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