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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Simtuzumab
Gemcitabine
Placebo to match simtuzumab
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring GSI, Gilead, Gilead Sciences, Pancreatic Cancer, PC, Gemcitabine, Phase 2, Phase II, GS-6624, Oncology, Monoclonal Antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birmingham Hematology and Oncology Associates, LLC
  • University of South Alabama Mitchell Cancer Institute
  • Central Hematology Oncology Medical Group, Inc.
  • Comprehensive Blood and Cancer Center
  • California Cancer Associates for Research and Excellence (CCARE)
  • Pacific Shores Medical Group
  • UCLA Community Oncology Practice
  • Stanford University Medical Center
  • Wilshire Oncology Medical Group, Inc.
  • Sharp Health Care
  • San Jose Medical Group
  • Saint Mary's Regional Cancer Center
  • Hematology Oncology Associates, PC
  • Florida Cancer Specialists
  • Georgia Cancer Specialists, P.C.
  • Northwestern University
  • Oncology Hematology Care, Inc.
  • Anne Arundel Medical Center, Annapolis Oncology Center
  • West Michigan Cancer Center
  • Providence Cancer Center Oncology and Hematology Care Clinic-Eastside Portland
  • Hematology and Oncology Associates at BridgePoint
  • Saint Joseph Oncology, Inc.
  • Washington University School of Medicine
  • Montana Cancer Institute Foundation c/o Montana Cancer Specialists
  • Comprehensive Cancer Centers of Nevada
  • Saint Luke's-Roosevelt Hospital Center
  • Beth Israel Comprehensive Cancer Center
  • Duke University Medical Center, Comprehensive Cancer Center
  • Emerywood Hematology and Oncology
  • Oncology Hematology Care, Inc.
  • PinnacleHealth
  • Abington Hematology Oncology Associates, Inc.
  • Charleston Hematology Oncology Associates, PA
  • South Carolina Oncology Associates
  • Tennessee Cancer Specialists
  • Tennessee Oncology, PLLC
  • Coastal Bend Cancer Center
  • University of Texas Southwestern Medical Center at Dallas
  • San Antonio Military Medical Center
  • Center for Cancer and Blood Disorders, PC
  • Joe Arrington Cancer Research and Treatment Center
  • Utah Cancer Specialists
  • Virginia Cancer Specialists, PC
  • Virginia Cancer Institute
  • Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
  • Medical Radiological Research Center of Russian Academy of Medical Sciences, Obninsk
  • State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
  • Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
  • Regional Oncology Dispensary
  • Kursk Regional Oncologic Dispensary
  • Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology
  • State Institution "Blokhin Cancer Research Centre RAMS"
  • Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD
  • Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
  • State Budgetary Healthcare Institution "Nizhny Novgorod Regional Oncological Dispensary"
  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
  • Petrov Research Oncology Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Simtuzumab (open-label)

Simtuzumab 200 mg (randomized)

Simtuzumab 700 mg (randomized)

Placebo (randomized)

Arm Description

Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.

Participants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years.

Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.

Participants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival
Overall survival is measured as time from date of randomization to death regardless of cause.
Objective response
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.

Full Information

First Posted
November 10, 2011
Last Updated
February 19, 2015
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01472198
Brief Title
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

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
GSI, Gilead, Gilead Sciences, Pancreatic Cancer, PC, Gemcitabine, Phase 2, Phase II, GS-6624, Oncology, Monoclonal Antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simtuzumab (open-label)
Arm Type
Experimental
Arm Description
Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Arm Title
Simtuzumab 200 mg (randomized)
Arm Type
Experimental
Arm Description
Participants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Arm Title
Simtuzumab 700 mg (randomized)
Arm Type
Experimental
Arm Description
Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Arm Title
Placebo (randomized)
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years.
Intervention Type
Drug
Intervention Name(s)
Simtuzumab
Other Intervention Name(s)
GS-6624
Intervention Description
Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar®
Intervention Description
Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Placebo to match simtuzumab
Intervention Description
Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
Primary Outcome Measure Information:
Title
Progression free survival
Description
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.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival is measured as time from date of randomization to death regardless of cause.
Time Frame
Up to 3 years
Title
Objective response
Description
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.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zung Thai, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Hematology and Oncology Associates, LLC
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
University of South Alabama Mitchell Cancer Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Central Hematology Oncology Medical Group, Inc.
City
Alhambra
State/Province
California
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
Country
United States
Facility Name
California Cancer Associates for Research and Excellence (CCARE)
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
Country
United States
Facility Name
UCLA Community Oncology Practice
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
Country
United States
Facility Name
Wilshire Oncology Medical Group, Inc.
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Sharp Health Care
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
San Jose Medical Group
City
San Jose
State/Province
California
ZIP/Postal Code
95116
Country
United States
Facility Name
Saint Mary's Regional Cancer Center
City
Grand Junction
State/Province
Colorado
Country
United States
Facility Name
Hematology Oncology Associates, PC
City
Stamford
State/Province
Connecticut
Country
United States
Facility Name
Florida Cancer Specialists
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Georgia Cancer Specialists, P.C.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Anne Arundel Medical Center, Annapolis Oncology Center
City
Annapolis
State/Province
Maryland
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
Country
United States
Facility Name
Providence Cancer Center Oncology and Hematology Care Clinic-Eastside Portland
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Hematology and Oncology Associates at BridgePoint
City
Tupelo
State/Province
Mississippi
Country
United States
Facility Name
Saint Joseph Oncology, Inc.
City
Saint Joseph
State/Province
Missouri
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Montana Cancer Institute Foundation c/o Montana Cancer Specialists
City
Missoula
State/Province
Montana
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
Country
United States
Facility Name
Saint Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Beth Israel Comprehensive Cancer Center
City
New York
State/Province
New York
Country
United States
Facility Name
Duke University Medical Center, Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Emerywood Hematology and Oncology
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Blue Ash
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
PinnacleHealth
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17109
Country
United States
Facility Name
Abington Hematology Oncology Associates, Inc.
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Charleston Hematology Oncology Associates, PA
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
South Carolina Oncology Associates
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Tennessee Cancer Specialists
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37206
Country
United States
Facility Name
Coastal Bend Cancer Center
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
Country
United States
Facility Name
San Antonio Military Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Center for Cancer and Blood Disorders, PC
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
City
Ufa
State/Province
Bashkortostan
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Medical Radiological Research Center of Russian Academy of Medical Sciences, Obninsk
City
Obninsk
State/Province
Kaluga
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
City
Arkhangelsk
State/Province
Primorskiy
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Regional Oncology Dispensary
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
Kursk Regional Oncologic Dispensary
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
State Institution "Blokhin Cancer Research Centre RAMS"
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Nizhny Novgorod Regional Oncological Dispensary"
City
Nizhny Novgorod
ZIP/Postal Code
603081
Country
Russian Federation
Facility Name
Budgetary Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Petrov Research Oncology Institute
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
28246206
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.
Results Reference
derived

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

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