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Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Simtuzumab
Placebo to match SIM
Leucovorin
Irinotecan
Fluorouracil
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring GSI, Gilead, Gilead Sciences, GS-6624, Colorectal Cancer, KRAS, Oncology, monoclonal antibody

Eligibility Criteria

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

Inclusion Criteria:

  • Metastatic colorectal carcinoma with KRAS mutation
  • Received first line therapy and discontinued part or all of first line therapy
  • Estimated life expectancy > 3 months
  • Stage IV disease
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
  • Adequate hepatic and hematologic function
  • No major operations within 4 weeks prior to treatment start

Exclusion Criteria:

  • More than 1 prior chemotherapy regimen for Stage 4 colorectal cancer
  • Experimental medical treatment within 30 days prior to study entry
  • Known or suspected cerebral metastases
  • History or presence of any form of cancer, other that colorectal cancer, within the 3 years prior to enrollment
  • Known dihydropyrimidine dehydrogenase-deficiency (special screening not required)
  • Subjects with angina pectoris, poorly controlled ventricular arrhythmias (does not include asymptomatic, occasional premature ventricular contractions), history of clinically significant coronary heart disease or cardiomyopathy, or electrocardiogram (ECG) abnormalities consistent with ischemia
  • Uncontrolled hypertension (seated systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg) at screening
  • Clinically active liver disease, including active hepatitis (any etiology) or cirrhosis
  • Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 21 days prior to randomization
  • Prior irinotecan therapy for metastatic disease is not permitted
  • Systemic fungal, bacterial, viral, or other infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Clearview Cancer Institute
  • Banner MD Anderson Cancer Center
  • Central Hematology Oncology Medical Group, Inc.
  • Comprehensive Blood and Cancer Center
  • Providence Saint Joseph Medical Center-Disney Family Cancer Center
  • Wilshire Oncology Medical Group, Inc.
  • Saint Jude Heritage Healthcare
  • University of California San Diego Medical Center
  • Pacific Shores Medical Group
  • Comprehensive Hematology Oncology Centers, Inc.
  • TORI Network (Translational Oncology Research Intl)
  • UCLA Community Oncology Practice
  • Stanford University Medical Center
  • Wilshire Oncology Medical Group, Inc.
  • Cancer Care Associates Medical Group
  • Pacific Shores Medical Group
  • Sharp Health Care
  • San Jose Medical Group
  • Central Coast Medical Oncology Corp
  • Yale University Smilow Cancer Hospital
  • Georgetown University
  • Florida Cancer Specialists
  • MD Anderson Cancer Center
  • Florida Cancer Specialists
  • Peachtree Hematology Oncology Consultants, PC
  • Suburban Hematology Oncology Associates, PC
  • Northwestern University
  • Indiana University Simon Cancer Center
  • Tufts Medical Center
  • Dana Farber Cancer Institute
  • West Michigan Cancer Center
  • Hematology and Oncology Associates at BridgePoint
  • Saint Joseph Oncology, Inc.
  • Montana Cancer Institute
  • Southeast Nebraska Cancer Center
  • Comprehensive Cancer Centers of Nevada
  • Comprehensive Cancer Centers of Nevada
  • New York University Clinical Cancer Center
  • Oncology Hematology Care, Inc.
  • Signal Point Clinical Research Center, LLC
  • Oncology Hematology Care, Inc.
  • Kaiser Permanente Northwest Region Oncology Hematology
  • South Carolina Oncology Associates
  • Tennessee Oncology, PLLC
  • University of Texas Southwestern Medical Center at Dallas
  • Center for Cancer and Blood Disorders, PC
  • Joe Arrington Cancer Research and Treatment Center
  • Scott & White Memorial
  • The Center for Cancer and Blood Disorders
  • Intermountain Healthcare
  • Utah Cancer Specialists
  • Virginal Cancer Specialists, PC
  • Virginia Cancer Institute
  • Virginia Cancer Institute
  • Seattle Cancer Care Alliance
  • University of Wisconsin
  • Centre Hospitalier Universitaire Estaing
  • Centre Eugène Marquis
  • Centre Georges François Leclerc
  • Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique
  • Centre Hospitalier Régional Universitaire Hôpital Saint Eloi
  • Centre Antoine Lacassagne
  • Institut Paoli Calmettes Centre Régional de Lutte Contre le Cancer
  • Hôpital Trousseau - Service de Gastroenterologie
  • Universitätsklinikum Ulm
  • Universitätsklinikums Mannheim
  • Ludwig-Maximilians-Universität München Klinikum Großhadern
  • Universitätsklinikum Rostock
  • Klinikum Region Hannover GmbH, Krankenhaus Siloah
  • Medizinische Universitätsklinik Bochum
  • Universitätsklinikum Essen
  • Krankenanstalt Mutterhaus der Borromäerinnen e.V.
  • Universitätsklinikum Dresden
  • Universitätsklinikum der Friedrich-Schiller-Universität Jena
  • Städtisches Klinikum Frankfurt-Höchst
  • Katholisches Marienkrankenhaus gGmbH
  • University Magdeburg
  • Ospedale Unico Versilia
  • Azienda Ospedaliera San Gerardo di Monza
  • Arcispedale Santa Maria Nuova IRCCS
  • Istituto Europeo di Oncologia
  • Ospedale Niguarda Cà Granda
  • Ospedale Civile SS Annunziata ASL 1
  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o.
  • Uniwersyteckie Centrum Kliniczne
  • Olsztynski Osrodek Onkologiczny "Kopernik" sp. z o. o.
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
  • Centralny Szpital Kliniczny MSWiA
  • Centrum Onkologii - Instytut im Marii Sklodowskiej-Curie
  • State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
  • Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
  • Kursk Regional Oncologic Dispensary
  • Cancer Research Center n.a. Blokhin, Chemotherapy Dept.
  • Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD"
  • State Institution "Blokhin Cancer Research Centre RAMS"
  • Nizhny Novgorod City Oncology Dispensary
  • State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
  • N.N.Petrov Research Institute of Oncology
  • Centro Oncológico Regional de Galicia
  • Hospital Nuestra Señora de Sonsoles
  • Hospital Universitario Vall d'Hebron
  • Hospital Universitario de Girona Doctor Josep Trueta
  • Hospital Universitario Ramón y Cajal
  • Hospital Clinico Universitario San Carlos
  • Hospital Universitario 12 de Octubre
  • Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
  • Hospital Universitario La Paz
  • Instituto de Investigación Sanitaria
  • Hospital Clinico Universitario de Valencia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

FOLFIRI + SIM 700 mg (Part A)

FOLFIRI + SIM 200 mg (Part B)

FOLFIRI + SIM 700 mg (Part B)

FOLFIRI + Placebo (Part B)

Arm Description

Participants will receive SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.

Participants will receive SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.

Participants will receive SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.

Participants will receive placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
The PFS was defined as the time from the date of randomization to the earliest event time of: a) death regardless of cause, or b) first indication of disease progression. PFS was analyzed using Kaplan-Meier (KM) estimates.

Secondary Outcome Measures

Overall Survival (OS)
The OS is measured as time from date of randomization to death regardless of cause. The OS was analyzed using KM estimates.
Objective Response Rate (ORR)
Objective response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). The ORR was defined as the percentage of participants who achieved a CR or PR.

Full Information

First Posted
November 9, 2011
Last Updated
March 26, 2019
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01479465
Brief Title
Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma
Official Title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With FOLFIRI as Second Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma That Has Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Study Start Date
December 2011 (Actual)
Primary Completion Date
October 2014 (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
The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
GSI, Gilead, Gilead Sciences, GS-6624, Colorectal Cancer, KRAS, Oncology, monoclonal antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FOLFIRI + SIM 700 mg (Part A)
Arm Type
Experimental
Arm Description
Participants will receive SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
Arm Title
FOLFIRI + SIM 200 mg (Part B)
Arm Type
Experimental
Arm Description
Participants will receive SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
Arm Title
FOLFIRI + SIM 700 mg (Part B)
Arm Type
Experimental
Arm Description
Participants will receive SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
Arm Title
FOLFIRI + Placebo (Part B)
Arm Type
Experimental
Arm Description
Participants will receive placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
Simtuzumab
Other Intervention Name(s)
SIM; GS-6624
Intervention Description
SIM administered via intravenous infusion over 30 minutes
Intervention Type
Drug
Intervention Name(s)
Placebo to match SIM
Intervention Description
Placebo to match SIM administered via intravenous infusion over 30 minutes
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
Folinic acid
Intervention Description
l-Leucovorin 200 mg/m^2 or dl-leucovorin 400 mg/m^2 administered via intravenous infusion over 2 hours
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Irinotecan 180 mg/m^2 administered via intravenous infusion over 90 minutes
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Intervention Description
Fluorouracil 400 mg/m^2 administered via intravenous bolus and 2400 mg/m^2 via intravenous infusion over 46 hours
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
The PFS was defined as the time from the date of randomization to the earliest event time of: a) death regardless of cause, or b) first indication of disease progression. PFS was analyzed using Kaplan-Meier (KM) estimates.
Time Frame
Randomization up to 27 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
The OS is measured as time from date of randomization to death regardless of cause. The OS was analyzed using KM estimates.
Time Frame
Randomization up to 33 months
Title
Objective Response Rate (ORR)
Description
Objective response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). The ORR was defined as the percentage of participants who achieved a CR or PR.
Time Frame
Randomization up to 27 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Metastatic colorectal carcinoma with KRAS mutation Received first line therapy and discontinued part or all of first line therapy Estimated life expectancy > 3 months Stage IV disease Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 Adequate hepatic and hematologic function No major operations within 4 weeks prior to treatment start Exclusion Criteria: More than 1 prior chemotherapy regimen for Stage 4 colorectal cancer Experimental medical treatment within 30 days prior to study entry Known or suspected cerebral metastases History or presence of any form of cancer, other that colorectal cancer, within the 3 years prior to enrollment Known dihydropyrimidine dehydrogenase-deficiency (special screening not required) Subjects with angina pectoris, poorly controlled ventricular arrhythmias (does not include asymptomatic, occasional premature ventricular contractions), history of clinically significant coronary heart disease or cardiomyopathy, or electrocardiogram (ECG) abnormalities consistent with ischemia Uncontrolled hypertension (seated systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg) at screening Clinically active liver disease, including active hepatitis (any etiology) or cirrhosis Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 21 days prior to randomization Prior irinotecan therapy for metastatic disease is not permitted Systemic fungal, bacterial, viral, or other infection Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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
Clearview Cancer Institute
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
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
Providence Saint Joseph Medical Center-Disney Family Cancer Center
City
Burbank
State/Province
California
Country
United States
Facility Name
Wilshire Oncology Medical Group, Inc.
City
Corona
State/Province
California
Country
United States
Facility Name
Saint Jude Heritage Healthcare
City
Fullerton
State/Province
California
Country
United States
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
Country
United States
Facility Name
Comprehensive Hematology Oncology Centers, Inc.
City
Los Angeles
State/Province
California
Country
United States
Facility Name
TORI Network (Translational Oncology Research Intl)
City
Los Angeles
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
Pomona
State/Province
California
Country
United States
Facility Name
Cancer Care Associates Medical Group
City
Redondo Beach
State/Province
California
Country
United States
Facility Name
Pacific Shores Medical Group
City
Redondo Beach
State/Province
California
Country
United States
Facility Name
Sharp Health Care
City
San Diego
State/Province
California
Country
United States
Facility Name
San Jose Medical Group
City
San Jose
State/Province
California
Country
United States
Facility Name
Central Coast Medical Oncology Corp
City
Santa Maria
State/Province
California
Country
United States
Facility Name
Yale University Smilow Cancer Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Florida Cancer Specialists
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
MD Anderson Cancer Center
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
Country
United States
Facility Name
Peachtree Hematology Oncology Consultants, PC
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Suburban Hematology Oncology Associates, PC
City
Lawrenceville
State/Province
Georgia
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
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
Montana Cancer Institute
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Southeast Nebraska Cancer Center
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
New York University Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Signal Point Clinical Research Center, LLC
City
Middletown
State/Province
Ohio
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Wilmington
State/Province
Ohio
Country
United States
Facility Name
Kaiser Permanente Northwest Region Oncology Hematology
City
Portland
State/Province
Oregon
Country
United States
Facility Name
South Carolina Oncology Associates
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
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
Scott & White Memorial
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
The Center for Cancer and Blood Disorders
City
Weatherford
State/Province
Texas
Country
United States
Facility Name
Intermountain Healthcare
City
Saint George
State/Province
Utah
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Virginal Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Facility Name
Virginia Cancer Institute
City
Midlothian
State/Province
Virginia
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
Centre Hospitalier Universitaire Estaing
City
Clermont Ferrand
State/Province
Auvergne
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes Cedex
State/Province
Bretagne
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
Country
France
Facility Name
Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique
City
Lille Cedex
Country
France
Facility Name
Centre Hospitalier Régional Universitaire Hôpital Saint Eloi
City
Montpellier Cedex 5
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice Cedex 2
Country
France
Facility Name
Institut Paoli Calmettes Centre Régional de Lutte Contre le Cancer
City
Rennes Cedex
Country
France
Facility Name
Hôpital Trousseau - Service de Gastroenterologie
City
Tours
Country
France
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitätsklinikums Mannheim
City
Mannheim
State/Province
Baden-Wuerttenberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Ludwig-Maximilians-Universität München Klinikum Großhadern
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitätsklinikum Rostock
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18055
Country
Germany
Facility Name
Klinikum Region Hannover GmbH, Krankenhaus Siloah
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30449
Country
Germany
Facility Name
Medizinische Universitätsklinik Bochum
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44892
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Krankenanstalt Mutterhaus der Borromäerinnen e.V.
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54290
Country
Germany
Facility Name
Universitätsklinikum Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum der Friedrich-Schiller-Universität Jena
City
Jena
State/Province
Thuringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
Städtisches Klinikum Frankfurt-Höchst
City
Frankfurt
Country
Germany
Facility Name
Katholisches Marienkrankenhaus gGmbH
City
Hamburg
ZIP/Postal Code
22045
Country
Germany
Facility Name
University Magdeburg
City
Magdeburg
Country
Germany
Facility Name
Ospedale Unico Versilia
City
Lido di Camaiore
State/Province
Lucca
ZIP/Postal Code
55043
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo di Monza
City
Monza
State/Province
Monza E Brianza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova IRCCS
City
Reggio Emilia
State/Province
Reggio Nella Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Ospedale Niguarda Cà Granda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Ospedale Civile SS Annunziata ASL 1
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o.
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Olsztynski Osrodek Onkologiczny "Kopernik" sp. z o. o.
City
Olsztyn
State/Province
Warminsko-Mazurskie
ZIP/Postal Code
10-513
Country
Poland
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
City
Bydgoszcz
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA
City
Warszawa
Country
Poland
Facility Name
Centrum Onkologii - Instytut im Marii Sklodowskiej-Curie
City
Warszawa
Country
Poland
Facility Name
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
City
Arkhangelsk
Country
Russian Federation
Facility Name
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
City
Kazan
Country
Russian Federation
Facility Name
Kursk Regional Oncologic Dispensary
City
Kursk
Country
Russian Federation
Facility Name
Cancer Research Center n.a. Blokhin, Chemotherapy Dept.
City
Moscow
Country
Russian Federation
Facility Name
Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD"
City
Moscow
Country
Russian Federation
Facility Name
State Institution "Blokhin Cancer Research Centre RAMS"
City
Moscow
Country
Russian Federation
Facility Name
Nizhny Novgorod City Oncology Dispensary
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
City
Omsk
Country
Russian Federation
Facility Name
N.N.Petrov Research Institute of Oncology
City
Saint Petersburg
Country
Russian Federation
Facility Name
Centro Oncológico Regional de Galicia
City
A Coruña
State/Province
La Coruna
ZIP/Postal Code
15009
Country
Spain
Facility Name
Hospital Nuestra Señora de Sonsoles
City
Avila
ZIP/Postal Code
05004
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario de Girona Doctor Josep Trueta
City
Gerona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Instituto de Investigación Sanitaria
City
Madrid
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28246207
Citation
Hecht JR, Benson AB 3rd, Vyushkov D, Yang Y, Bendell J, Verma U. A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Simtuzumab in Combination with FOLFIRI for the Second-Line Treatment of Metastatic KRAS Mutant Colorectal Adenocarcinoma. Oncologist. 2017 Mar;22(3):243-e23. doi: 10.1634/theoncologist.2016-0479. Epub 2017 Feb 28.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

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