A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma
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
1 other identifier
interventional
250
2 countries
57
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pancreatic-cancer
Started Nov 2011
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 10, 2011
CompletedFirst Posted
Study publicly available on registry
November 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMarch 10, 2015
February 1, 2015
1.9 years
November 10, 2011
February 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
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.
Up to 3 years
Secondary Outcomes (2)
Overall survival
Up to 3 years
Objective response
Up to 3 years
Study Arms (4)
Simtuzumab (open-label)
EXPERIMENTALParticipants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Simtuzumab 200 mg (randomized)
EXPERIMENTALParticipants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Simtuzumab 700 mg (randomized)
EXPERIMENTALParticipants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Placebo (randomized)
PLACEBO COMPARATORParticipants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years.
Interventions
Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (57)
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36604, 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, 93720, 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, 91730, United States
Sharp Health Care
San Diego, California, 92123, United States
San Jose Medical Group
San Jose, California, 95116, 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, 33607, United States
Georgia Cancer Specialists, P.C.
Atlanta, Georgia, 30341, United States
Northwestern University
Chicago, Illinois, United States
Oncology Hematology Care, Inc.
Crestview Hills, Kentucky, 41017, 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, 48075, 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, 63108, United States
Montana Cancer Institute Foundation c/o Montana Cancer Specialists
Missoula, Montana, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Saint Luke's-Roosevelt Hospital Center
New York, New York, 10003, United States
Beth Israel Comprehensive Cancer Center
New York, New York, United States
Duke University Medical Center, Comprehensive Cancer Center
Durham, North Carolina, United States
Emerywood Hematology and Oncology
High Point, North Carolina, United States
Oncology Hematology Care, Inc.
Blue Ash, Ohio, 45242, United States
PinnacleHealth
Harrisburg, Pennsylvania, 17109, United States
Abington Hematology Oncology Associates, Inc.
Willow Grove, Pennsylvania, 19090, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37206, 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, 78234, 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, 84106, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
Ufa, Bashkortostan Republic, 450054, Russia
Regional Oncology Dispensary
Ivanovo, Ivanovo Oblast, 153040, Russia
Medical Radiological Research Center of Russian Academy of Medical Sciences, Obninsk
Obninsk, Kaluga Oblast, 249036, Russia
Kursk Regional Oncologic Dispensary
Kursk, Kursk Oblast, 305035, Russia
Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology
Moscow, Moscow, 115478, Russia
State Institution "Blokhin Cancer Research Centre RAMS"
Moscow, Moscow, 115478, Russia
Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD
Moscow, Moscow, 125367, Russia
Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
Moscow, Moscow, 129128, Russia
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
Arkhangelsk, Primorskiy (Maritime) Kray, 163045, Russia
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
Kazan', Tatarstan Republic, 420029, Russia
State Budgetary Healthcare Institution "Nizhny Novgorod Regional Oncological Dispensary"
Nizhny Novgorod, 603081, Russia
Budgetary Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
Omsk, 644013, Russia
Petrov Research Oncology Institute
Saint Petersburg, 197758, Russia
Related Publications (1)
Benson AB 3rd, Wainberg ZA, Hecht JR, Vyushkov D, Dong H, Bendell J, Kudrik F. A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Simtuzumab or Placebo in Combination with Gemcitabine for the First-Line Treatment of Pancreatic Adenocarcinoma. Oncologist. 2017 Mar;22(3):241-e15. doi: 10.1634/theoncologist.2017-0024. Epub 2017 Feb 28.
PMID: 28246206DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zung Thai, MD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2011
First Posted
November 16, 2011
Study Start
November 1, 2011
Primary Completion
October 1, 2013
Study Completion
February 1, 2015
Last Updated
March 10, 2015
Record last verified: 2015-02