NCT03032484已完成2 期
A Phase 2 Investigator Initiated Study to Determine the Efficacy and Safety of TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma
The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年5月18日最近更新:
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
- 25
- 试验地点
- 1
- 主要终点
- Progression Free Survival at 6 Months (PFS6)
研究概览
简要总结
Randomized phase 2 study TVB-2640 in combination with Bevacizumab versus Bevacizumab alone.
详细描述
Eligible patients will be randomized into 2 separate arms:
- Arm number one will receive Bevacizumab every 2 weeks in combination with TVB-2640 from day 1 until day 28 of the first cycle.
- Arm number two will receive Bevacizumab alone every 2 weeks, from on days 1 and 15 of the first until day 28 of the first cycle.
- MR-Spectroscopy will be obtained on all patients (both arms) at day 28 of first cycle.
- Starting on cycle 2 day 1, all patients will converge to a single arm and will continue to receive bevacizumab every 2 weeks in combination with TVB-2640. Every cycle will last 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 high-grade astrocytoma
- •Progression following standard combined modality treatment with radiation and temozolomide chemotherapy
- •Recovered from reversible toxicities of prior therapy to Grade 0 or Grade 1
- •ECOG Performance Status of 0 to 2
- •Life expectancy of at least 3 months
- •Adequate renal and liver function: AST/ALT ≤ 3 x ULN, Bilirubin ≤ 1.5 times ULN, Creatinine ≤ ULN
- •Adequate hematologic status (without hematologic support): Hemoglobin ≥ 9 g/dL, ANC ≥ 1500 cells/ml, Platelets ≥ 100,000 cells/ml
- •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 (for example, surgical sterilization or the use of 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 six months after the last dose.
排除标准
- •Receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug
- •Evidence of acute intracranial or intratumoral hemorrhage either by MRI or CT scan. Subjects with resolving hemorrhage changes punctuate hemorrhage, or hemosiderin are eligible
- •Unable to undergo MRI scan (e.g., pacemaker)
- •Received enzyme-inducing anti-epileptic agents within 14 days of study drug (e.g., carbamazepine, phenytoin, phenobarbital, primidone)
- •Not recovered to a NCI CTCAE v.4.03 Grade ≤ 1 from AEs (except alopecia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug
- •Evidence of wound dehiscence
- •Pregnant or breast-feeding
- •Clinically significant Dry Eye or necessary contact lens use
- •Serious intercurrent illness such as: Hypertension (two or more blood pressure readings performed at screening of > 150 mmHg systolic or > 100 mmHg diastolic) despite optimal treatment, Non-healing wound or ulcer, Uncontrolled life threatening cardiac arrhythmias, Untreated hypothyroidism, Uncontrolled active infection, Symptomatic congestive heart failure or unstable angina pectoris within 3 months prior to study drug, Gastrointestinal perforation, abdominal fistula, intra-abdominal abscess within 1 year
- •Inherited bleeding diathesis or coagulopathy with the risk of bleeding
- •HIV , Hepatitis B or C documented infections
- •Received any of the following prior anticancer therapy: Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed, Non-antiangiogenic therapy (including investigational agents and small molecular kinase inhibitors) within 7 days or 5 half-lives, whichever is shorter, prior to the 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
研究组 & 干预措施
Bevacizumab and TVB-2640
Experimental
Bevacizumab every 2 weeks in combination with TVB-2640 dosed at 100mg/m2 daily (rounded to 50mg tab dose), from day 1 until day 28 of the first cycle.
干预措施: Bevacizumab (Drug)
Bevacizumab and TVB-2640
Experimental
Bevacizumab every 2 weeks in combination with TVB-2640 dosed at 100mg/m2 daily (rounded to 50mg tab dose), from day 1 until day 28 of the first cycle.
干预措施: TVB-2640 (Drug)
Bevacizumab for Cycle 1, then Bevacizumab and TVB-2640
Experimental
Bevacizumab alone every 2 weeks, on days 1 and 15 until day 28 of the first cycle, and then receive both Bevacizumab and TVB-2640 for the remainder of their participation in this study.
干预措施: Bevacizumab (Drug)
Bevacizumab for Cycle 1, then Bevacizumab and TVB-2640
Experimental
Bevacizumab alone every 2 weeks, on days 1 and 15 until day 28 of the first cycle, and then receive both Bevacizumab and TVB-2640 for the remainder of their participation in this study.
干预措施: TVB-2640 (Drug)
结局指标
主要结局
Progression Free Survival at 6 Months (PFS6)
时间窗: 6 months
Survival of participants at 6 months after the start of treatment without their condition becoming any worse. Brain magnetic resonance imaging (MRI) was performed after every even cycle (e.g., C2, C4) during treatment, with tumor response assessed by the investigator for complete response (CR), partial response (PR) and PD according to the Response Assessment in Neuro-oncology (RANO) criteria.
次要结局
- Incidence, Nature and Severity of Adverse Events and Serious Adverse Events, Graded According to NCI - Common Toxicity Criteria for Adverse Events Version (4.03)(Up to 6 28-day cycles)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or GliosarcomaAdult GlioblastomaAdult GliosarcomaRecurrent Adult Brain NeoplasmNCT00433381National Cancer Institute (NCI)123
终止
2 期
Trial of the Combination of Bevacizumab and Everolimus in Patients With Refractory, Progressive Intracranial MeningiomaIntracranial MeningiomaNCT00972335SCRI Development Innovations, LLC18
已完成
2 期
Bevacizumab Combined With Fractionated Stereotactic Radiotherapy for 1 to 10 Brain Metastases From NSCLCNon-small Cell Lung CancerNCT04345146Sun Yat-sen University100
进行中（未招募）
1 期
Estudio abierto fase II de bevacizumab en combinación con paclitaxel y gemcitabina como tratamiento de primera línea en pacientes diagnosticados de carcinoma de mama metastasico o localmente avanzado HER-2 negativo - AvaluzEUCTR2008-003657-32-ESRoche Farma S.A.85
已完成
2 期
A Study of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous NSCLC (PASSPORT)Brain NeoplasmsNon-Small Cell Lung CancerNCT00312728Genentech, Inc.115