NCT01063816已完成1 期
A Phase 1 Study of Veliparib in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors
AbbVie (prior sponsor, Abbott)0 个研究点目标入组 79 人开始时间: 2010年1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
- 79
- 主要终点
- Determine the maximum tolerated dose and recommended Phase 2 dose
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose of veliparib (ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when administered in combination with carboplatin and gemcitabine in subjects with advanced solid tumors.
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
- •Histologically or cytologically confirmed solid tumors that are metastatic or unrespectable for which carboplatin/gemcitabine is a treatment option.
- •Eastern Cooperative Group performance score of 0 to
- •Adequate hematologic, hepatic and renal function
- •Subject has received up to 2 DNA damaging or cytotoxic regimens in the past five years
排除标准
- •Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within 28 days prior to study administration.
- •Subjects with known history of brain metastases and primary CNS tumors.
- •Hypersensitivity reactions to platinum compounds or gemcitabine.
- •Clinically significant and uncontrolled major medical conditions
- •Active malignancy within the past 5 years except for any cancer in situ cured or non-melanoma carcinoma of the skin.
研究组 & 干预措施
Arm 1
Experimental
干预措施: veliparib (ABT-888) (Drug)
Arm 1
Experimental
干预措施: carboplatin (Drug)
Arm 1
Experimental
干预措施: gemcitabine (Drug)
结局指标
主要结局
Determine the maximum tolerated dose and recommended Phase 2 dose
时间窗: ABT-888 will be dose escalated until the largest dose is reached based on the probability of dose, limiting toxicities is based per continual reassessment method (CRM).
次要结局
- Safety assessment: Clinical Laboratory Tests(Screening, Day 1 and Day 8 of each cycle, Final Visit and 30 Day Follow-up Visit)
- Safety assessment: Adverse event assessments(All study visits)
- Pharmacokinetics Area Under the Curve (AUC)(Timepoints: 30 and 45 minutes, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5,6,6.5, 7 and 8 hours past dose)
- Tumor assessment(Screening, every nine weeks and Final Visit)
- Safety assessment: Electrocardiogram(Screening, Day 8 of each Cycle of drug and Final Visit)
- Physical exam including vital signs(Screening, Cycle 1 Day 8, Day 1 of all cycles starting with Cycle2, Final Visit and 30 Day Follow-up Visit)
研究者
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