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

Not Recruiting

Trial ID: NCT01472198


This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.

Official Title

A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma

Stanford Investigator(s)

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine


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

   - 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

   - 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


drug: Gemcitabine

drug: Simtuzumab

drug: Placebo to match simtuzumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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