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

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 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
• Measurable disease (at least one target lesion outside of previous radiation fields) or non-measurable disease by RECIST v.1.1 criteria
• Documentation of disease progression since any prior therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least 3 month
• Acceptable liver, renal function and acceptable hematological status
• Other protocol defined inclusion criteria may apply

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
• Other protocol defined exclusion criteria may apply