A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT01472198
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (randomized) Placebo to match simtuzumab Participants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years. Simtuzumab 700 mg (randomized) Gemcitabine Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years. Simtuzumab (open-label) Simtuzumab Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years. Simtuzumab 200 mg (randomized) Simtuzumab Participants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years. Simtuzumab (open-label) Gemcitabine Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years. Simtuzumab 700 mg (randomized) Simtuzumab Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years. Simtuzumab 200 mg (randomized) Gemcitabine Participants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years. Placebo (randomized) Gemcitabine Participants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years.
- Primary Outcome Measures
Name Time Method Progression free survival Up to 3 years Progression free survival is measured as time from date of randomization to the earliest event time of death regardless of cause or first indication of disease progression.
- Secondary Outcome Measures
Name Time Method Overall survival Up to 3 years Overall survival is measured as time from date of randomization to death regardless of cause.
Objective response Up to 3 years Objective response is assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as complete response, partial response, stable disease, or progressive disease.
Trial Locations
- Locations (56)
UCLA Community Oncology Practice
🇺🇸Los Angeles, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Henderson, Nevada, United States
Montana Cancer Institute Foundation c/o Montana Cancer Specialists
🇺🇸Missoula, Montana, United States
South Carolina Oncology Associates
🇺🇸Columbia, South Carolina, United States
Regional Oncology Dispensary
🇷🇺Ivanovo, Russian Federation
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
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
Georgia Cancer Specialists, P.C.
🇺🇸Atlanta, Georgia, United States
Anne Arundel Medical Center, Annapolis Oncology Center
🇺🇸Annapolis, Maryland, United States
Providence Cancer Center Oncology and Hematology Care Clinic-Eastside Portland
🇺🇸Southfield, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Hematology and Oncology Associates at BridgePoint
🇺🇸Tupelo, Mississippi, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Saint Joseph Oncology, Inc.
🇺🇸Saint Joseph, Missouri, United States
Beth Israel Comprehensive Cancer Center
🇺🇸New York, New York, United States
Saint Luke's-Roosevelt Hospital Center
🇺🇸New York, New York, United States
Duke University Medical Center, Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
PinnacleHealth
🇺🇸Harrisburg, Pennsylvania, United States
Tennessee Cancer Specialists
🇺🇸Knoxville, Tennessee, United States
Abington Hematology Oncology Associates, Inc.
🇺🇸Willow Grove, Pennsylvania, United States
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
Coastal Bend Cancer Center
🇺🇸Corpus Christi, Texas, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
San Antonio Military Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Center for Cancer and Blood Disorders, PC
🇺🇸Fort Worth, Texas, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Virginia Cancer Specialists, PC
🇺🇸Fairfax, Virginia, United States
Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
🇷🇺Ufa, Bashkortostan, Russian Federation
Medical Radiological Research Center of Russian Academy of Medical Sciences, Obninsk
🇷🇺Obninsk, Kaluga, Russian Federation
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
🇷🇺Arkhangelsk, Primorskiy, Russian Federation
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
🇷🇺Kazan, Tatarstan, Russian Federation
Kursk Regional Oncologic Dispensary
🇷🇺Kursk, Russian Federation
Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology
🇷🇺Moscow, Russian Federation
State Institution "Blokhin Cancer Research Centre RAMS"
🇷🇺Moscow, Russian Federation
Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD
🇷🇺Moscow, Russian Federation
Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
🇷🇺Moscow, Russian Federation
State Budgetary Healthcare Institution "Nizhny Novgorod Regional Oncological Dispensary"
🇷🇺Nizhny Novgorod, Russian Federation
Budgetary Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
🇷🇺Omsk, Russian Federation
Petrov Research Oncology Institute
🇷🇺Saint Petersburg, Russian Federation
Florida Cancer Specialists
🇺🇸Tampa, Florida, United States
Oncology Hematology Care, Inc.
🇺🇸Blue Ash, Ohio, United States
Birmingham Hematology and Oncology Associates, LLC
🇺🇸Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
Emerywood Hematology and Oncology
🇺🇸High Point, North Carolina, United States
Charleston Hematology Oncology Associates, PA
🇺🇸Charleston, South Carolina, United States