NCT02342379已完成2 期
A Phase 2, Investigator Initiated Study to Determine the Safety and Efficacy of TH-302 in Combination With Bevacizumab for Glioblastoma Following Bevacizumab Failure
The University of Texas Health Science Center at San Antonio2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Number of Patients With Adverse Events
研究概览
简要总结
Dual center, single arm, two-stage, non-blinded, prospective study of combination therapy bevacizumab at 10mg/kg and TH-302 at 670mg/m2 every 2 weeks (6 week cycle) until disease progression.
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
- •At least 18 years of age
- •Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
- •Histologically confirmed glioblastoma
- •Progression following both standard combined modality treatment with radiation and temozolomide chemotherapy, as well as bevacizumab
- •Recovered from toxicities of prior therapy to grade 0 or 1
- •ECOG performance status ≤ 2
- •Life expectancy of at least 3 months
- •Acceptable liver function:
- •Bilirubin ≤ 1.5 times upper limit of normal
- •AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN);
- •Acceptable renal function:
- •a. Serum creatinine ≤ULN
- •Acceptable hematologic status (without hematologic support):
- •ANC ≥1500 cells/uL
- •Platelet count ≥100,000/uL
- •Hemoglobin ≥9.0 g/dL
- •All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose
排除标准
- •The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.
- •The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage, punctate hemorrhage, or hemosiderin are eligible.
- •The subject is unable to undergo MRI scan (eg, has pacemaker).
- •The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
- •The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade ≤ 1 from AEs (except alopecia, anemia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug.
- •The subject has evidence of wound dehiscence
- •Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause normal tissue hypoxia
- •The subject is pregnant or breast-feeding.
- •The subject has serious intercurrent illness, such as:
- •hypertension (two or more blood pressure [BP] readings performed at screening of > 150 mmHg systolic or > 100 mmHg diastolic) despite optimal treatment
- •non-healing wound, ulcer, or bone fracture
- •significant cardiac arrhythmias
- •untreated hypothyroidism
- •uncontrolled active infection
- •symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug
- •myocardial infarction, stroke, transient ischemic attack within 6 months
- •gastrointestinal perforation, abdominal fistula, intra- abdominal abscess within 1 year
- •history or clinical evidence of pancreatitis within 2 years
- •The subject has inherited bleeding diathesis or coagulopathy with the risk of bleeding.
- •The subject has received any of the following prior anticancer therapy:
- •Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed
- •Non-bevacizumab systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior first dose of study drug
- •Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug
- •Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug
- •Prior treatment with carmustine wafers
- •Prior treatment with TH-302
研究组 & 干预措施
Bevacizumab and TH-302
Experimental
Patients will be treated with combination of bevacizumab and TH-302.
干预措施: Bevacizumab (Drug)
Bevacizumab and TH-302
Experimental
Patients will be treated with combination of bevacizumab and TH-302.
干预措施: TH-302 (Drug)
结局指标
主要结局
Number of Patients With Adverse Events
时间窗: 4 months
Safety lab tests and adverse event assessment
次要结局
- Progression Free Survival(4 months)
研究者
研究点 (2)
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