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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT01472198

Run by

Gilead Sciences

People needed

250

Starts

2011-11-01

Expected to finish

2015-02-01

Last updated by the study team

2015-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR
• Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreatic origin in conjunction with either:
• The presence of a mass in the pancreas OR
• 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.

You may not qualify if…

• 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

Where it is running

• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
• Central Hematology Oncology Medical Group, Inc. — Alhambra, California, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• California Cancer Associates for Research and Excellence (CCARE) — Fresno, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• UCLA Community Oncology Practice — Los Angeles, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Wilshire Oncology Medical Group, Inc. — Rancho Cucamonga, California, United States
• Sharp Health Care — San Diego, California, United States
• San Jose Medical Group — San Jose, California, United States
• Saint Mary's Regional Cancer Center — Grand Junction, Colorado, United States
• Hematology Oncology Associates, PC — Stamford, Connecticut, United States
• Florida Cancer Specialists — Tampa, Florida, United States
• Georgia Cancer Specialists, P.C. — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Oncology Hematology Care, Inc. — Crestview Hills, Kentucky, United States
• Anne Arundel Medical Center, Annapolis Oncology Center — Annapolis, Maryland, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• Providence Cancer Center Oncology and Hematology Care Clinic-Eastside Portland — Southfield, Michigan, United States
• Hematology and Oncology Associates at BridgePoint — Tupelo, Mississippi, United States
• Saint Joseph Oncology, Inc. — Saint Joseph, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Montana Cancer Institute Foundation c/o Montana Cancer Specialists — Missoula, Montana, United States
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
• Birmingham Hematology and Oncology Associates, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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