JPRN-jRCT2080222461已完成3 期
A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH-302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma(EMR 200592-001)
Merck KGaA, (in all countries except the US and Japan), EMD Serono, Inc., (in the US), Meck Serono Co., Ltd. (in Japan)0 个研究点目标入组 660 人开始时间: 2014年4月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 660
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.At least 18 years of age (At least 20 years of age in Japan)
- •2.Locally advanced unresectable or metastatic pancreatic ductal 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;
- •3.Measurable disease (at least one target lesion outside of previous radiation fields) or non-measurable disease by RECIST v.1.1 criteria
- •4.Documentation of disease progression since any prior therapy
- •5.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •6.Life expectancy of at least 3 months
- •7.Acceptable liver, renal function and acceptable hematological status
- •8.Other protocol defined inclusion criteria may apply
排除标准
- •- New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction within 6 months prior to the date of randomization, unstable arrhythmia or symptomatic peripheral arterial vascular disease
- •- Symptomatic ischemic heart disease
- •- Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
- •- Previous malignancy other than pancreatic cancer in the last 5 years, except for adequately treated non-melanoma skin cancer or pre-invasive cancer of the cervix
- •- Severe chronic obstructive or other pulmonary disease with hypoxemia
- •- Major surgery, other than diagnostic surgery, less than or equal to 28 days prior to the date of randomization. Subject must have completely recovered from surgery
- •- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- •- Treatment of pancreatic cancer with radiation therapy or surgery less than or equal to 28 days prior to the date of randomization
- •- Prior therapy with a hypoxic cytotoxin
- •- Subjects who participated in an investigational drug or device trial less than or equal to 28 days prior to Day 1 of the first cycle
- •- Known infection with Human Immunodeficiency Virus (HIV), or an active infection with Hepatitis B or Hepatitis C
- •- Subjects who have exhibited allergic reactions to a structural compound similar to TH-302 or the drug product excipients or to gemcitabine or its excipients
- •- Other protocol defined exclusion criteria may apply
研究者
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