NCT00649207已完成1 期
A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of ABT-888 in Combination With Whole Brain Radiation Therapy in Subjects With Brain Metastases
AbbVie (prior sponsor, Abbott)9 个研究点 分布在 3 个国家目标入组 80 人开始时间: 2008年3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
- 80
- 试验地点
- 9
- 主要终点
- Determine the maximum tolerated dose of ABT-888 in combination with whole brain radiation therapy
研究概览
简要总结
This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given together with Whole Brain Radiation Therapy (WBRT) in treating patients with brain metastases.
详细描述
This is a Phase 1, multicenter, dose-escalation study evaluating the safety, tolerability and pharmacokinetics of the PARP inhibitor ABT-888 in combination with conventional whole brain radiation therapy (WBRT) in the treatment of subjects with solid tumors metastatic to the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age is greater than or equal to 18 years.
- •Histologically or cytologically confirmed non-CNS primary solid malignancy.
- •Pathologically or radiographically confirmed metastatic disease in the brain. Subjects with non-measurable lesions, including leptomeningeal carcinomatosis, are eligible.
- •WBRT is clinically indicated, with the exception of prophylactic treatment.
- •Karnofsky Performance Status (KPS) greater than or equal to a score of
- •Adequate hematology, renal and hepatic function.
- •Both men and women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and up to 2 months following completion of protocol therapy.
- •Total abstinence from sexual intercourse (minimum one complete menstrual cycle)
- •A vasectomized partner * Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration
- •Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
- •Subject is capable of understanding and complying with parameters as outlined in the protocol.
- •Subject or the subject's legally acceptable representative has voluntarily signed and dated the informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
排除标准
- •Brain metastases secondary to germ cell tumor or lymphoma malignancy.
- •Primary central nervous system (CNS) neoplasm.
- •Prior or concurrent administration of the following therapies or treatments:
- •Prior treatment with WBRT
- •SRS performed less than 14 days prior to WBRT D1, or is scheduled to occur within 30 days of the last WBRT session
- •Last dose of chemotherapy, immunotherapy, biologic therapy, or investigational therapy was less than 14 days prior to WBRT D
- •Bisphosphonates, hormone modification therapy, and trastuzumab are permitted without restriction
- •Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment.
- •Known seizure disorder (status epileptics) that is uncontrolled, or seizures occurring greater than or equal to 3 times a week over the past month.
- •If female, subject is pregnant or breast-feeding.
- •Clinically significant and uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or neurological/psychiatric disease or disorder, including but not limited to:
- •Active uncontrolled infection
- •Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- •Any other illness condition(s) that could exacerbate potential toxicities, confound safety assessments, require excluded therapy for management, or limit compliance with study requirements
- •Unable to swallow and retain oral medications.
- •Known contraindication to enhanced MRI and CT, including but not limited to:
- •Presence of metal objects within the body such as a cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel
- •History of immediate or delayed hypersensitivity reaction or other contraindication to contrast agents including but not limited to gadolinium and iodine
- •Previous enrollment in this study or another study involving the investigation of ABT-888, with the exception of receiving a single dose of study drug.
- •Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-888 and/or WBRT.
研究组 & 干预措施
1
Experimental
This is an open label study; therefore, there are no numbered/labeled study arms.
This is a dose escalation study, ABT-888 dose will be escalated in conjunction with two schedules of whole brain radiation therapy (WBRT). Subjects may be treated WBRT for 3 weeks (15 days) or 2 weeks (10 days).
干预措施: Whole Brain Radiation Therapy (Radiation)
1
Experimental
This is an open label study; therefore, there are no numbered/labeled study arms.
This is a dose escalation study, ABT-888 dose will be escalated in conjunction with two schedules of whole brain radiation therapy (WBRT). Subjects may be treated WBRT for 3 weeks (15 days) or 2 weeks (10 days).
干预措施: ABT-888 (Drug)
结局指标
主要结局
Determine the maximum tolerated dose of ABT-888 in combination with whole brain radiation therapy
时间窗: ABT-888 will be dose escalated until the largest dose is reached that is felt to be safe based on safety information from all subjects.
次要结局
- Safety Assessment Mini-Mental State Examination(be performed at all study visits, final and follow-up visit)
- Safety Assessment Laboratory testing(be performed at all study visits, final and follow-up visit)
- Safety Assessment Physical and Neurological Exam(be performed at all study visits, final and follow-up visit)
研究者
研究点 (9)
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