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