NCT02034916终止2 期
A PHASE 2, 2-STAGE, 2-COHORT STUDY OF TALAZOPARIB (BMN 673) ADMINISTERED TO GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 84
- 试验地点
- 70
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:
- Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or
- Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed carcinoma of the breast
- •Locally advanced and/or metastatic disease
- •Deleterious or pathogenic germline BRCA 1 or BRCA 2 mutation
- •Prior chemotherapy: Cohort 1) PR or CR to prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or Cohort 2) > 2 prior chemotherapy regimens for metastatic disease and no prior platinum for metastatic disease
- •ECOG performance status ≤ 1
- •Have adequate organ function
排除标准
- •Prior enrollment into a clinical trial of a PARP inhibitor
- •CNS metastasis except adequately treated brain metastasis documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids for management of CNS symptoms
- •Prior malignancy except for prior BRCA-associated cancer as long as there is no current evidence of the prior cancer, carcinoma in situ of the cervix or non-melanoma skin cancer, and a cancer diagnosed and definitively treated >5 years prior to study enrollment with no subsequent evidence of recurrence
- •Known to be HIV positive, active hepatitis C virus, or active hepatitis B virus
- •Known hypersensitivity to any of the components of talazoparib
研究组 & 干预措施
talazoparib
Experimental
Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum
Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease
干预措施: talazoparib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From randomization until data cutoff date (01 Sep 2016)
ORR: Percentage of participants with a confirmed best overall complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1). CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to less than (\<) 10 millimeter (mm) in short axis. PR: Greater than or equal to (\>=) 30 percent (%) decrease in sum of diameters of target lesions, compared to the sum at baseline. Response evaluation was done by an independent radiology facility (IRF).
次要结局
- Number of Participants With Outcome in Response to Adverse Events (AEs)(Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018))
- Number of Participants With Toxicity Grades Increase of 2 or More in Laboratory Parameter (Hematology Parameter)(Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018))
- Clinical Benefit Rate-24 (CBR-24)(From randomization until data cutoff date (01 Sep 2016))
- Duration of Response (DOR)(From first documentation of CR or PR until PD, last tumor assessment without PD before new anticancer treatment initiation or death due to any cause, whichever occurred first (up to the data cutoff date [01 Sep 2016]))
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018))
- Progression Free Survival (PFS)(From first dose of study drug until PD, last tumor assessment without PD before new anticancer treatment initiation or death due to any cause, whichever occurred first (up to the data cutoff date [01 Sep 2016]))
- Overall Survival (OS)(From first dose of study drug until death due to any cause (up to the data cutoff date [01 Sep 2016]))
- Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018))
- Trough Concentration Versus Time Summary of Talazoparib(Predose on Day 1 of Cycle 1, 2, 3, and 4 (data cutoff date: 01 Sep 2016))
- Number of Participants With Toxicity Grades Increase of 2 or More in Laboratory Parameter (Chemistry Parameter)(Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016]))
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs(Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018))
- Number of Participants With Clinically Significant Change From Baseline in Physical Findings(Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018))
- Number of Participants With At Least 1 Concomitant Medication(Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018))
研究者
研究点 (70)
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