Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
2019年10月4日 更新者：Tracon Pharmaceuticals Inc.
A Phase 1b Dose-escalation Study of TRC105 in Combination With Paclitaxel/Carboplatin and Bevacizumab in Patients With Stage 4 Non-Squamous Cell Lung Cancer
This is a single center, open-label, nonrandomized, phase 1b, dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
研究概览
详细说明
Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in non-squamous non-small cell lung cancer (NSCLC) patients when given with carboplatin and paclitaxel.
TRC105 is an antibody to endoglin, an essential angiogenic target expressed on proliferating endothelial cells that is distinct from the VEGFR and overexpressed in response to VEGF inhibition.
TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models and complements the activity of antibodies and small molecules that target the VEGFR.
In a phase 1b study, the combination of TRC105 and bevacizumab produced radiographic reductions in tumor volume in bevacizumab-refractory patients, and was well tolerated.
TRC105 was also well tolerated with chemotherapy in a trial with capecitabine in breast cancer patients.
The use of TRC105 with bevacizumab and paclitaxel/carboplatin may result in more effective angiogenesis inhibition and improved clinical efficacy over that seen with bevacizumab and paclitaxel/carboplatin alone.
研究类型
介入性
注册 (实际的)
15
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Key Inclusion Criteria:
- Stage 4 Non-Squamous Cell Lung Cancer that has not been treated previously with systemic chemotherapy or bevacizumab, but may have received prior targeted treatment (e.g., alk1 inhibitor)
- ECOG performance status ≤ 1
- Measurable disease by RECIST
Key Exclusion Criteria:
- Non-small cell lung cancer of squamous histology
- Current treatment on another therapeutic clinical trial
- Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy
- Active bleeding or pathologic condition that carries a high risk of bleeding (e.g. hereditary hemorrhagic telangiectasia). Patients who have been uneventfully anti-coagulated with low molecular weight heparin are eligible.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：TRC105 + B + P + C
TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
|
Dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Treatment-Emergent Adverse Events
大体时间：from screening until completion of follow-up, on average 6 months
|
Incidence of treatment-emergent (i.e.
TRC105, bevacizumab, paclitaxel and/or carboplatin) adverse events by CTCAE v4.03
|
from screening until completion of follow-up, on average 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall RECIST 1.1 Response Rate
大体时间：6 months
|
Response rate determined according to RECIST 1.1 criteria
|
6 months
|
|
Percent of Patients With Progression-free Survival (PFS) at 6 Months
大体时间：6 months
|
Number of patients with progression-free survival at 6 months determined according to RECIST 1.1 criteria
|
6 months
|
|
Median Progression Free Survival
大体时间：months
|
Median duration of progression free survival according to RECIST 1.1 criteria
|
months
|
|
Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin
大体时间：3 months
|
Trough serum TRC105 pharmacokinetic concentrations at steady state (cycle 3 day 1) will be measured using validated ELISA methods.
|
3 months
|
|
Number of Patients Who Have TRC105 Positive Anti-Product Antibodies
大体时间：6 months
|
Anti-product antibody concentrations will be measured using validated ELISA methods.
Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles.
|
6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Charles Theuer, MD、TRACON Pharmaceuticals
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年9月1日
初级完成 (实际的)
2019年6月1日
研究完成 (实际的)
2019年6月1日
研究注册日期
首次提交
2018年11月13日
首先提交符合 QC 标准的
2018年12月17日
首次发布 (实际的)
2018年12月19日
研究记录更新
最后更新发布 (实际的)
2019年10月28日
上次提交的符合 QC 标准的更新
2019年10月4日
最后验证
2019年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
TRC105的临床试验
-
National Cancer Institute (NCI)完全的
-
National Cancer Institute (NCI)完全的
-
University of Alabama at BirminghamTracon Pharmaceuticals Inc.完全的
-
Tracon Pharmaceuticals Inc.完全的