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

Trial ID or NCT#

NCT01472198

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

George A. Fisher Jr.
George A. Fisher Jr.
Medical oncologist, Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine

Contact us to find out if this trial is right for you.

Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov