EUCTR2012-002957-42-AT
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Merck KGaA
- Enrollment
- 660
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •\- 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.
Exclusion Criteria
- •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.
Investigators
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