NCT02326844终止2 期
A Phase 2 Pilot Study of BMN 673 (Talazoparib), an Oral PARP Inhibitor, in Patients With Deleterious BRCA1/2 Mutation-Associated Ovarian Cancer Who Have Had Prior PARP Inhibitor Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Objective Response (Complete Response (CR) + Partial Response (PR))
研究概览
简要总结
Background:
- The new drug BMN 673 (talazoparib) has been shown to fight tumor cells in animals and some people. It is a poly (ADP-ribose) polymerase (PARP) inhibitor. It works on tumor cell deoxyribonucleic acid (DNA) damage repair process. Researchers want to see if BMN 673 shrinks cancer again in women with ovarian cancer and whose cancer initially got shrunk but grew back on the first PARP inhibitor.
Objective:
- To study BMN 673 (talazoparib) in people with ovarian cancer born with a breast cancer (BRCA) mutation and whose cancer got shrunk but became worse after they took a similar drug.
Eligibility:
- Women at least 18 years old:
- with recurrent and/or metastatic germline breast cancer mutation (gBRCAm)-associated ovarian cancer AND
- whose disease is growing after already being treated with PARP inhibitors AND
- with no other treatment(s) in between the first PARP inhibitors and a screening visit.
Design:
- Participants will be screened with medical history, physical exam, and heart and blood tests.
- Participants will take the study drug by mouth once daily. They will take the drug in 28-day cycles.
- They will keep a diary of doses and any side effects.
- Participants will have 4 study visits in cycle 1, then 1 visit every cycle. Visits may include:
- Blood tests
- Physical exam
- Computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants will lie in a machine that takes pictures of their body.
- Ultrasound
- Participants will have a biopsy before starting the study drug. A small piece of tumor tissue will be removed by needle, guided by a scan. They may have two more biopsies later.
- Participants will be followed for 30 days after taking the last dose of study drug. A physical exam, blood tests, and CT or other scans will be done.
- Participants will have follow-up calls to ask about any side effects.
详细描述
Background:
- Patients with germline BRCA1/2 mutations (gBRCAm) demonstrate repeated therapeutic susceptibility to deoxyribonucleic acid (DNA) damaging agents, especially platinums, even if they have previously progressed on a similar (platinum-based) regimen.
- Poly (ADP-ribose) polymerase (PARP) inhibitors (PARPi) have clinical activity in gBRCAm-associated malignancies, although patients eventually develop progressive disease.
- BMN 673 (talazoparib) is a novel PARPi, with excellent oral bioavailability and greater anti-tumor activity in vitro and in vivo at lower concentrations than first generation PARPi.
- It is unknown whether secondary BRCA mutations or other potential mechanisms of clinical resistance portend cross-resistance to a highly potent PARPi.
Objectives:
-To determine the objective response rate (complete response (CR)+partial response (PR)) of single agent BMN 673 (talazoparib) in ovarian cancer patients with gBRCAm who have progressed on prior PARPi therapy.
Eligibility:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ovarian Cancer Patients
Experimental
Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy
干预措施: BMN 673 (talazoparib) (Drug)
结局指标
主要结局
Objective Response (Complete Response (CR) + Partial Response (PR))
时间窗: Every 2 cycles, an average of 64 days
Objective response (complete response (CR) + partial response (PR)) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
次要结局
- Number of Participants With Serious and Non-serious Adverse Events(15 months)
- Duration of Response(3 months)
- Progression Free Survival (PFS) on BMN673 (Talazoparib) to PFS From First Poly (ADP-ribose) Polymerase Inhibitor (PARPPi) Exposure(3 months)
研究者
Jung-Min Lee, M.D.
Principal Investigator
National Cancer Institute (NCI)
研究点 (1)
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