A Phase 2 Evaluation of TRC105 In Combination With Bevacizumab for the Treatment Of Recurrent or Progressive Glioblastoma That Has Progressed on Bevacizumab
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Median Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with recurrent or progressive glioblastoma after prior antiangiogenic therapy (including anti-VEGF therapy)
详细描述
Angiogenesis plays a central role in the progression of solid cancer. TRC105 is an antibody to CD105, an important non-VEGF angiogenic target on proliferating endothelial cells. TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models. TRC105 has been well tolerated in patients with glioblastoma (GBM) as a single agent. The combination of TRC105 in combination with bevacizumab has demonstrated activity in bevacizumab refractory cancer patients. We hypothesize that TRC105 when administered with bevacizumab will have activity in GBM patients who progress on bevacizumab. By targeting a non-VEGF pathway, TRC105 has the potential to complement VEGF inhibition by bevacizumab, which could represent a major advance in GBM therapy.
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
- •Patients with histologically confirmed glioblastoma, recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy.
- •Patients with documented radiographic progression following bevacizumab therapy for treatment of glioblastoma.
- •Patients with up to 3 prior recurrences are allowed.
- •Karnofsky performance status ≥ 70%.
- •Age ≥ 18 years old.
- •Normal organ function
排除标准
- •Patients who have had previous treatment with TRC
- •Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
- •Patients with cirrhosis, or active viral or nonviral hepatitis.
- •Patients with active bleeding or pathologic conditions that carry a high risk of bleeding,(i.e. hereditary hemorrhagic telangiectasia).
- •Patients who are currently receiving anticoagulation treatment
- •Patients unwilling or unable to comply with the protocol
研究组 & 干预措施
TRC105, Bevacizumab
Single arm study
干预措施: TRC105 (Drug)
TRC105, Bevacizumab
Single arm study
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Median Overall Survival (OS)
时间窗: 6 Months
Overall survival assessed by determination from time of informed consent on trial to the date of death of each patient enrolled in the trial
次要结局
- Median Duration That Patients Remained Progression Free on Study(Patients are scanned every 8 weeks for approximately 6 months)
- Number of Participants With Adverse Events(Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, an average of 4 months)
- Number of Patients Who Respond to Study Treatment According to Modified RANO Criteria (Objective Response Rate (ORR)).(Patients are scanned every 8 weeks)