NCT01589419已完成1 期
An Open-Label Phase 1b Study of the Safety and Tolerability of Veliparib in Combination With Capecitabine and Radiation in Subjects With Locally Advanced Rectal Cancer (LARC)
AbbVie (prior sponsor, Abbott)6 个研究点 分布在 2 个国家目标入组 32 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 6
- 主要终点
- Determine the maximum tolerated dose (MTD) and/or establish the recommended phase two dose (RPTD)
研究概览
简要总结
An open-label, Phase 1b, dose escalation study evaluating the safety and tolerability of the PARP inhibitor Veliparib in combination with capecitabine and radiation in subjects with locally advanced rectal cancer (LARC).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be ≥ 18 years of age
- •All subjects must have newly diagnosed, histologically proven adenocarcinoma of the rectum
- •All subjects must have an abdominal/pelvis computed tomography (CT ) scan or magnetic resonance imaging (MRI) confirming no evidence of distant metastases
- •Distal border of tumor < 12 cm from anal verge
- •Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 to 2
- •No prior treatment for LARC however prior treatments for other cancers are acceptable as long as they are considered curative
排除标准
- •Subject is an unsuitable candidate for TME surgery
- •Subject has received anticancer therapy
- •Subject has received prior radiation therapy
- •Subject has had major surgery within 28 days prior to the first dose of study drug
- •History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption
研究组 & 干预措施
veliparib and capecitabine and radiation
Experimental
Veliparib on days 1-7, capecitabine and radiation on days 1-5
干预措施: veliparib (Drug)
veliparib and capecitabine and radiation
Experimental
Veliparib on days 1-7, capecitabine and radiation on days 1-5
干预措施: capecitabine (Drug)
veliparib and capecitabine and radiation
Experimental
Veliparib on days 1-7, capecitabine and radiation on days 1-5
干预措施: radiation (Radiation)
结局指标
主要结局
Determine the maximum tolerated dose (MTD) and/or establish the recommended phase two dose (RPTD)
时间窗: From first study drug dose and at each weekly treatment visit until dose-limiting toxicities (DLT) observed or completion of dosing period (anticipated to be approximately 5 weeks).
次要结局
- Assess the pharmacokinetic profile by area under the curve vs. dose of veliparib(Multiple measurements over time points (0, .5, 1, 2, 3, 4, 6 hours post dose) Day 1, Day 2 and at the pre-dose time point on Day 5 and week 2 visit.)
- Assess the safety (number of participants with adverse events and types of adverse events observed)(From screening and ongoing at each weekly treatment visit through dosing period (anticipated to be approximately 5 weeks), prior to surgery and at the final visit.)
- Assess the tolerability (number of participants with adverse events and types of adverse events observed)(From first study drug dose and ongoing at each weekly treatment visit, through completion of dosing period (anticipated to be approximately 5 weeks).)
研究者
研究点 (6)
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