Clinical trial NCT01472198: A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: GSI
Gilead
Gilead Sciences
Pancreatic Cancer
PC
Gemcitabine
Phase 2
Phase II
GS-6624
Oncology
Monoclonal Antibody
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-11-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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

Primary outcomes:
measure: Progression free survival
timeFrame: Up to 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 3 years
measure: Objective response
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology Associates, LLC
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama Mitchell Cancer Institute
state: Alabama
city: Alhambra
country: United States
facility: Central Hematology Oncology Medical Group, Inc.
state: California
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Fresno
country: United States
facility: California Cancer Associates for Research and Excellence (CCARE)
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: UCLA Community Oncology Practice
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Rancho Cucamonga
country: United States
facility: Wilshire Oncology Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Sharp Health Care
state: California
city: San Jose
country: United States
facility: San Jose Medical Group
state: California
city: Grand Junction
country: United States
facility: Saint Mary's Regional Cancer Center
state: Colorado
city: Stamford
country: United States
facility: Hematology Oncology Associates, PC
state: Connecticut
city: Tampa
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Atlanta
country: United States
facility: Georgia Cancer Specialists, P.C.
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Crestview Hills
country: United States
facility: Oncology Hematology Care, Inc.
state: Kentucky
city: Annapolis
country: United States
facility: Anne Arundel Medical Center, Annapolis Oncology Center
state: Maryland
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Southfield
country: United States
facility: Providence Cancer Center Oncology and Hematology Care Clinic-Eastside Portland
state: Michigan
city: Tupelo
country: United States
facility: Hematology and Oncology Associates at BridgePoint
state: Mississippi
city: Saint Joseph
country: United States
facility: Saint Joseph Oncology, Inc.
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Missoula
country: United States
facility: Montana Cancer Institute Foundation c/o Montana Cancer Specialists
state: Montana
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: New York
country: United States
facility: Saint Luke's-Roosevelt Hospital Center
state: New York
city: New York
country: United States
facility: Beth Israel Comprehensive Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center, Comprehensive Cancer Center
state: North Carolina
city: High Point
country: United States
facility: Emerywood Hematology and Oncology
state: North Carolina
city: Blue Ash
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Harrisburg
country: United States
facility: PinnacleHealth
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Hematology Oncology Associates, Inc.
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, PA
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncology Associates
state: South Carolina
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Corpus Christi
country: United States
facility: Coastal Bend Cancer Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Fort Sam Houston
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Center for Cancer and Blood Disorders, PC
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Ufa
country: Russian Federation
facility: Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
state: Bashkortostan
city: Obninsk
country: Russian Federation
facility: Medical Radiological Research Center of Russian Academy of Medical Sciences, Obninsk
state: Kaluga
city: Arkhangelsk
country: Russian Federation
facility: State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
state: Primorskiy
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
state: Tatarstan
city: Ivanovo
country: Russian Federation
facility: Regional Oncology Dispensary
city: Kursk
country: Russian Federation
facility: Kursk Regional Oncologic Dispensary
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology
city: Moscow
country: Russian Federation
facility: State Institution "Blokhin Cancer Research Centre RAMS"
city: Moscow
country: Russian Federation
facility: Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD
city: Moscow
country: Russian Federation
facility: Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
city: Nizhny Novgorod
country: Russian Federation
facility: State Budgetary Healthcare Institution "Nizhny Novgorod Regional Oncological Dispensary"
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
city: Saint Petersburg
country: Russian Federation
facility: Petrov Research Oncology Institute
Study officials:
affiliation: Gilead Sciences
name: Zung Thai, MD
role: STUDY_DIRECTOR
References:
citation: 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.