NCT02047500终止1 期
An Open-Label, Phase I Dose Escalation Trial of TH-302 in Combination With Gemcitabine and Nab-Paclitaxel in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- Number of Subjects Experiencing Dose Limiting Toxicity (DLT)
研究概览
简要总结
This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma.
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
- •Subjects greater than or equal to (>=) 18 years of age with locally advanced unresectable or metastatic pancreatic adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than:
- •Radiosensitizing doses of 5-fluorouracil;
- •Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
- •Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection;
- •Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy
- •Subjects may have measurable or non-measurable disease according to RECIST 1.
- •Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- •Acceptable hematological status, liver and renal function as defined in the protocol
- •Other protocol defined inclusion criteria could apply
排除标准
- •Significant cardiac or peripheral vascular arterial disease
- •Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
- •Severe chronic obstructive or other pulmonary disease with hypoxemia
- •Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- •Subjects receiving concomitant treatment with radiotherapy or other investigational drugs
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
TH-302 plus Nab-paclitaxel plus Gemcitabine
Experimental
干预措施: TH-302 (Drug)
TH-302 plus Nab-paclitaxel plus Gemcitabine
Experimental
干预措施: Nab-paclitaxel (Drug)
TH-302 plus Nab-paclitaxel plus Gemcitabine
Experimental
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Number of Subjects Experiencing Dose Limiting Toxicity (DLT)
时间窗: Up to Day 28 of Cycle 1
次要结局
- Percentage of Subjects With Disease Control According to RECIST Version 1.1 Criteria(Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment)
- Tumor Metabolic Response Assessed by Positron Emission Tomography (PET) Scans According to European Organization for Research and Treatment of Cancer (EORTC) Criteria(Baseline and 8 weeks after Day 1 of Cycle 1)
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs)(Baseline up to Day 30 after the last dose of study treatment)
- Duration of Overall Response According to RECIST Version 1.1 Criteria(Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment)
- Progression Free Survival (PFS) Time(Time from enrollment to progressive disease (PD) or occurrence of death due to any cause within 120 days of either first administration of study drug or the last tumor assessment)
- Percentage of Subjects With Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1) Criteria(Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment)
研究者
研究点 (5)
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