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

Merck KGaA0 个研究点目标入组 660 人开始时间: 2013年12月20日最近更新: 2016年8月8日

适应症

试验速览

暂无简介。

•- At least 18 years of age.
•- Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven by
•histology or cytology and previously untreated with chemotherapy or systemic therapy
•- Measurable disease (at least one target lesion outside of previous radiation fields) or
•non-measurable disease by RECIST 1.1 criteria (see Appendix III).
•- Documentation of disease progression since any prior therapy.
•- Life expectancy of at least 3 months.
•- Acceptable liver function.
•- Acceptable renal function.
•- Acceptable hematologic status.
•- Other protocol defined inclusion criteria may applied
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 260
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 400

•1. 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.
•2. Symptomatic ischemic heart disease.
•3. Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at
•least 3 months).
•4. 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.
•5. Severe chronic obstructive or other pulmonary disease with hypoxemia
•6. Major surgery, other than diagnostic surgery, =28 days prior to the date of randomization.
•Subject must have completely recovered from surgery.
•7. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
•8. Treatment of pancreatic cancer with radiation therapy or surgery =28 days prior to the date of
•randomization.
•9. Prior therapy with a hypoxic cytotoxin.
•10. Subjects who participated in an investigational drug or device trial =28 days prior to Day 1 of
•the first cycle.
•11. Known infection with HIV, or an active infection with hepatitis B or hepatitis C.
•12. 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.
•13. Other protocol defined exclusion criteria may applied.

发起方