NCT01908478已完成1 期
A Phase I Study of Veliparib (ABT-888) in Combination With Gemcitabine and Intensity Modulated Radiation Therapy in Patients With Locally Advanced, Unresectable Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Maximum-tolerated dose (MTD) of veliparib based on the incidence of dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
研究概览
简要总结
This is a Phase I Study of veliparib (ABT-888) in combination with Gemcitabine and Intensity Modulated Radiation Therapy in Patients with Locally Advanced, Unresectable Pancreatic Cancer.
Primary Objectives:
- Determine the maximum tolerable dose of veliparib in combination with gemcitabine and intensity modulated radiation therapy in patients with locally advanced pancreatic cancer.
- Determine the safety and toxicity of the combination of veliparib with gemcitabine and radiation therapy in patients with locally advanced pancreatic cancer
详细描述
Gemcitabine will be administered by intravenous infusion of 1000 mg/m2 over 30 minutes on days 1, 8, 15 of the cycle. Intensity modulated radiation therapy (IMRT) will be given to a total dose of 36 Gy in 15 fractions (2.4 Gy per fraction, one fraction per day, 5 fractions per week, Monday through Friday) beginning on day 1. Veliparib will be administered per a dose escalation schema. The starting dose of veliparib is 20 mg BID based upon safety/efficacy data available. Dose escalation will continue in 20 mg increments until the maximum tolerated dose (MTD) is reached. Intra-patient dose escalation will not be allowed.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histopathological or cytological diagnosis of adenocarcinoma of the pancreas, as well as those with high clinical suspicion of adenocarcinoma, which is deemed locally advanced unresectable or borderline resectable as determined by a pancreatic cancer surgeon and/or following evaluation by a GI oncology tumor board.
- •Age 18 years or older
排除标准
- •Patients who have had prior anti-cancer treatment for their disease
- •Patients who are currently receiving any other investigational agents
- •Metastatic disease
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to PARP [Poly (ADP-ribosome) polymerase] inhibitors or gemcitabine
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
Combination: veliparib, gemcitabine, and IMRT
Experimental
干预措施: Intensity modulated radiation therapy (Radiation)
Combination: veliparib, gemcitabine, and IMRT
Experimental
干预措施: Veliparib (Drug)
Combination: veliparib, gemcitabine, and IMRT
Experimental
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Maximum-tolerated dose (MTD) of veliparib based on the incidence of dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
时间窗: Days 1-70
次要结局
- Assessment of objective response rates measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)(From baseline to Week 26)
- Evaluation of pre-treatment biopsy specimens for levels of various DNA repair proteins(Baseline only)
- Change in PAR [Poly(ADP-ribosyl)ation] levels in peripheral blood mononuclear cells(Baseline, Weekly for 6 weeks, and at Weeks 10, 18, and 26)
研究者
Richard Tuli, MD
Assistant Professor, Radiation Oncology
Cedars-Sinai Medical Center
研究点 (1)
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