NCT01472783已完成1 期
Veliparib (ABT888) Monotherapy for Patients With BRCA Germline Mutation and Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Phase I: Maximum tolerated dose, dose limiting toxicity, recommended phase II dose.
研究概览
简要总结
The main purpose of this study is to investigate the effect of veliparib in ovarian cancer patients with known BRCA 1/2 mutations who do no longer respond to conventional chemotherapy.
详细描述
The side effects are modest, since PARP inhibitors affect cancer cells to a much larger extent than normal cells. The effect of this PARP-inhibiting treatment is evident although the greatest effect is seen in patients with mutations in BRCA genes. The reason for this is that BRCA deficient cancer cells are unable to repair both DNA double strand and single strand breaks and undergo apoptosis to a large extent.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. Stages I-IV.
- •Patients with known germline BRCA1/2 mutations
- •Verified progression by either RECIST criteria and/or GCIG CA125 criteria after previous first line chemotherapy or progression after later lines of cytotoxic treatment.
- •Platinum resistance or partially platinum sensitive disease (Relapsed within six months of prior first line/later lines of platinum-based therapy or relapsed within six to twelve months of prior first line/later lines of platinum-based therapy)
- •Age ≥ 18 years.
- •Performance status 0-
- •Measurable disease by RECIST 1.1 or evaluable by CA125 GCIG criteria
- •Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to randomization):
- •WBC ≥ 3.0 x 10^9/l or neutrophils (ANC) ≥ 1.5 x 10^9/l Platelet count ≥ 100 x 10^9/l Hemoglobin ≥ 9.7 g/dl (6 mmol/L) Serum bilirubin ≤ 1.5 x ULN Serum transaminases ≤ 2.5 x ULN Serum creatinine ≤ 1.5 x ULN
- •Written informed consent.
- •Tissue available for BRCAness analysis.
排除标准
- •Previous treatment with a PARP inhibitor.
- •Platinum-refractory disease (disease that progressed or was stable during prior platinum therapy)
- •Patients who have received (or are planning to receive) treatment with any other investigational regimen, or who have participated in another clinical trial within 28 days prior to entering this trial.
- •Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
- •Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months after treatment
- •Other present or previous malignancy except curatively treated cervical cancer stage I, non-melanotic skin cancer or other cancer with minimal risk of relapse.
- •Curatively treated prior breast cancer is allowed if no relapse is suspected at time of inclusion.
- •CNS metastasis.
- •History of any chronic medical or psychiatric condition or laboratory abnormality that is not medically controlled or in the opinion of the Investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension, renal or liver disease).
- •Allergy to the ingredients of the study medication.
研究组 & 干预措施
Veliparib
Experimental
干预措施: Veliparib (Drug)
结局指标
主要结局
Phase I: Maximum tolerated dose, dose limiting toxicity, recommended phase II dose.
时间窗: 6 months
Phase II: Response rate
时间窗: Every 3 months
次要结局
- Progression free survival(Every 3 months)
- Overall survival(Every 3 months)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
A study to investigate the effect of Veliparib® (ABT888) in patients with BRCA mutations and relapse of ovarian cancer.EUCTR2011-002099-18-DKVejle Hospital33
已完成
2 期
Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal CancerBRCA1 Mutation CarrierBRCA2 Mutation CarrierOvarian Epithelial TumorRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaNCT01540565National Cancer Institute (NCI)52
已完成
3 期
ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer PatientsFallopian Tube CancerPeritoneal CancerOvarian CancerEpithelial Ovarian CancerNCT02855944pharmaand GmbH349
进行中（未招募）
2 期
Pembrolizumab in Treating Participants With Recurrent Ovarian CancerRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaNCT03732950Jonsson Comprehensive Cancer Center5
已完成
2 期
Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases From Non-Small Cell Lung CancerBrain Metastases From Non-small Cell Lung CancerNCT01657799AbbVie (prior sponsor, Abbott)307