Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

Exclusion Criteria

• •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