A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma

Inclusion Criteria:

   - Initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior to
   the completion of screening.

   - The presence of measurable metastatic pancreatic cancer documented by contrast
   enhanced CT (or MRI) scan in addition to 1 of the following:

      1. Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR

      2. Pathologist confirmed histological/cytological diagnosis of adenocarcinoma
      consistent with pancreatic origin in conjunction with either:

         1. The presence of a mass in the pancreas OR

         2. A history of resected pancreatic carcinoma

   - Measurable disease per RECIST (ver. 1.1)

   - ECOG Performance Status of 0 or 1.

   - Adequate hepatic, hematologic and renal functions.

Exclusion Criteria:

   - A history or evidence of clinically significant disorder other than metastatic cancer
   of the pancreas.

   - A diagnosis of pancreatic islet neoplasms.

   - Subject has undergone major surgery other than diagnosis surgery within 4 weeks of
   randomization

   - Presence of biliary obstruction requiring external drainage

   - Brain metastases.

   - Unstable cardiovascular function within the last 6 months of screening

   - Clinically active liver disease, including active viral hepatitis (HBV or HCV) or
   cirrhosis

   - Known HIV infection.

   - Uncontrolled hypertension at Screening

   - History or presence of any form of cancer, other than pancreatic cancer, within the 3
   years prior to enrollment

   - Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular
   targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable
   locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy
   given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced
   pancreatic cancer are allowed.

   - Uncontrolled systemic fungal, bacterial or viral infection

   - Participation in an investigational drug or device trial with therapeutic intent
   within 30 days prior to study