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

March 26, 2019 updated by: Gilead Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
266

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France
        • Centre Georges Francois Leclerc
      • Lille Cedex, France
        • Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique
      • Montpellier Cedex 5, France
        • Centre Hospitalier Régional Universitaire Hôpital Saint Eloi
      • Nice Cedex 2, France
        • Centre Antoine Lacassagne
      • Rennes Cedex, France
        • Institut Paoli Calmettes Centre Régional de Lutte Contre le Cancer
      • Tours, France
        • Hôpital Trousseau - Service de Gastroenterologie
    • Auvergne
      • Clermont Ferrand, Auvergne, France, 63003
        • Centre Hospitalier Universitaire Estaing
    • Bretagne
      • Rennes Cedex, Bretagne, France, 35042
        • Centre Eugène Marquis
  • Germany
      • Frankfurt, Germany
        • Städtisches Klinikum Frankfurt-Höchst
      • Hamburg, Germany, 22045
        • Katholisches Marienkrankenhaus gGmbH
      • Magdeburg, Germany
        • University Magdeburg
    • Baden-Wuerttemberg
      • Ulm, Baden-Wuerttemberg, Germany, 89081
        • Universitätsklinikum Ulm
    • Baden-Wuerttenberg
      • Mannheim, Baden-Wuerttenberg, Germany, 68167
        • Universitätsklinikums Mannheim
    • Bayern
      • München, Bayern, Germany, 81377
        • Ludwig-Maximilians-Universität München Klinikum Großhadern
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18055
        • Universitätsklinikum Rostock
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30449
        • Klinikum Region Hannover GmbH, Krankenhaus Siloah
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44892
        • Medizinische Universitätsklinik Bochum
      • Essen, Nordrhein-Westfalen, Germany, 45122
        • Universitätsklinikum Essen
    • Rheinland-Pfalz
      • Trier, Rheinland-Pfalz, Germany, 54290
        • Krankenanstalt Mutterhaus der Borromäerinnen e.V.
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Universitätsklinikum Dresden
    • Thuringen
      • Jena, Thuringen, Germany, 07747
        • Universitätsklinikum der Friedrich-Schiller-Universität Jena
  • Italy
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia
      • Milano, Italy, 20162
        • Ospedale Niguarda CA Granda
      • Sassari, Italy, 07100
        • Ospedale Civile SS Annunziata ASL 1
    • Lucca
      • Lido di Camaiore, Lucca, Italy, 55043
        • Ospedale Unico Versilia
    • Monza E Brianza
      • Monza, Monza E Brianza, Italy, 20052
        • Azienda Ospedaliera San Gerardo di Monza
    • Reggio Nella Emilia
      • Reggio Emilia, Reggio Nella Emilia, Italy, 42100
        • Arcispedale Santa Maria Nuova IRCCS
  • Poland
      • Bydgoszcz, Poland
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
      • Warszawa, Poland
        • Centralny Szpital Kliniczny Mswia
      • Warszawa, Poland
        • Centrum Onkologii - Instytut im Marii Sklodowskiej-Curie
    • Malopolskie
      • Kraków, Malopolskie, Poland, 31-826
        • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o.
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
    • Warminsko-Mazurskie
      • Olsztyn, Warminsko-Mazurskie, Poland, 10-513
        • Olsztynski Osrodek Onkologiczny "Kopernik" sp. z o. o.
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
      • Kazan, Russian Federation
        • Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
      • Kursk, Russian Federation
        • Kursk Regional Oncologic Dispensary
      • Moscow, Russian Federation
        • Cancer Research Center n.a. Blokhin, Chemotherapy Dept.
      • Moscow, Russian Federation
        • Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD"
      • Moscow, Russian Federation
        • State Institution "Blokhin Cancer Research Centre RAMS"
      • Nizhny Novgorod, Russian Federation
        • Nizhny Novgorod City Oncology Dispensary
      • Omsk, Russian Federation
        • State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
      • Saint Petersburg, Russian Federation
        • N.N.Petrov Research Institute of Oncology
  • Spain
      • Avila, Spain, 05004
        • Hospital Nuestra Señora de Sonsoles
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Gerona, Spain, 17007
        • Hospital Universitario de Girona Doctor Josep Trueta
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain, 28040
        • Hospital Clinico Universitario San Carlos
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal, Hospital de Madrid Norte-San Chinarro
      • Madrid, Spain
        • Instituto de Investigacion Sanitaria
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
    • La Coruna
      • A Coruña, La Coruna, Spain, 15009
        • Centro Oncologico Regional de Galicia
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Clearview Cancer Institute
    • Arizona
      • Gilbert, Arizona, United States
        • Banner MD Anderson Cancer Center
    • California
      • Alhambra, California, United States
        • Central Hematology Oncology Medical Group, Inc.
      • Bakersfield, California, United States
        • Comprehensive Blood and Cancer Center
      • Burbank, California, United States
        • Providence Saint Joseph Medical Center-Disney Family Cancer Center
      • Corona, California, United States
        • Wilshire Oncology Medical Group, Inc.
      • Fullerton, California, United States
        • Saint Jude Heritage Healthcare
      • La Jolla, California, United States
        • University of California San Diego Medical Center
      • Long Beach, California, United States
        • Pacific Shores Medical Group
      • Los Angeles, California, United States
        • UCLA Community Oncology Practice
      • Los Angeles, California, United States
        • Comprehensive Hematology Oncology Centers, Inc.
      • Los Angeles, California, United States
        • TORI Network (Translational Oncology Research Intl)
      • Palo Alto, California, United States
        • Stanford University Medical Center
      • Pomona, California, United States
        • Wilshire Oncology Medical Group, Inc.
      • Redondo Beach, California, United States
        • Cancer Care Associates Medical Group
      • Redondo Beach, California, United States
        • Pacific Shores Medical Group
      • San Diego, California, United States
        • SHARP Health Care
      • San Jose, California, United States
        • San Jose Medical Group
      • Santa Maria, California, United States
        • Central Coast Medical Oncology Corp
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University Smilow Cancer Hospital
    • District of Columbia
      • Washington, District of Columbia, United States
        • Georgetown University
    • Florida
      • Gainesville, Florida, United States
        • Florida Cancer Specialists
      • Orlando, Florida, United States
        • MD Anderson Cancer Center
      • Saint Petersburg, Florida, United States
        • Florida Cancer Specialists
    • Georgia
      • Atlanta, Georgia, United States
        • Peachtree Hematology Oncology Consultants, PC
      • Lawrenceville, Georgia, United States
        • Suburban Hematology Oncology Associates, PC
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University Simon Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States
        • Dana Farber Cancer Institute
    • Michigan
      • Kalamazoo, Michigan, United States
        • West Michigan Cancer Center
    • Mississippi
      • Tupelo, Mississippi, United States
        • Hematology and Oncology Associates at BridgePoint
    • Missouri
      • Saint Joseph, Missouri, United States
        • Saint Joseph Oncology, Inc.
    • Montana
      • Missoula, Montana, United States, 59802
        • Montana Cancer Institute
    • Nebraska
      • Lincoln, Nebraska, United States
        • Southeast Nebraska Cancer Center
    • Nevada
      • Henderson, Nevada, United States
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States
        • Comprehensive Cancer Centers of Nevada
    • New York
      • New York, New York, United States, 10016
        • New York University Clinical Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States
        • Oncology Hematology Care, Inc.
      • Middletown, Ohio, United States
        • Signal Point Clinical Research Center, LLC
      • Wilmington, Ohio, United States
        • Oncology Hematology Care, Inc.
    • Oregon
      • Portland, Oregon, United States
        • Kaiser Permanente Northwest Region Oncology Hematology
    • South Carolina
      • Columbia, South Carolina, United States
        • South Carolina Oncology Associates
    • Tennessee
      • Nashville, Tennessee, United States
        • Tennessee Oncology, PLLC
    • Texas
      • Dallas, Texas, United States
        • University of Texas Southwestern Medical Center at Dallas
      • Fort Worth, Texas, United States
        • Center for Cancer and Blood Disorders, PC
      • Lubbock, Texas, United States
        • Joe Arrington Cancer Research and Treatment Center
      • Temple, Texas, United States, 76508
        • Scott & White Memorial
      • Weatherford, Texas, United States
        • The Center for Cancer and Blood Disorders
    • Utah
      • Saint George, Utah, United States
        • Intermountain Healthcare
      • Salt Lake City, Utah, United States
        • Utah Cancer Specialists
    • Virginia
      • Fairfax, Virginia, United States, 22033
        • Virginal Cancer Specialists, PC
      • Midlothian, Virginia, United States
        • Virginia Cancer Institute
      • Richmond, Virginia, United States
        • Virginia Cancer Institute
    • Washington
      • Seattle, Washington, United States
        • Seattle Cancer Care Alliance
    • Wisconsin
      • Madison, Wisconsin, United States
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FOLFIRI + SIM 700 mg (Part A)
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.
Biological: Simtuzumab
SIM administered via intravenous infusion over 30 minutes
Other Names:
  • SIM; GS-6624
Drug: Leucovorin
l-Leucovorin 200 mg/m^2 or dl-leucovorin 400 mg/m^2 administered via intravenous infusion over 2 hours
Other Names:
  • Folinic acid
Drug: Irinotecan
Irinotecan 180 mg/m^2 administered via intravenous infusion over 90 minutes
Drug: Fluorouracil
Fluorouracil 400 mg/m^2 administered via intravenous bolus and 2400 mg/m^2 via intravenous infusion over 46 hours
Experimental: FOLFIRI + SIM 200 mg (Part B)
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.
Biological: Simtuzumab
SIM administered via intravenous infusion over 30 minutes
Other Names:
  • SIM; GS-6624
Drug: Leucovorin
l-Leucovorin 200 mg/m^2 or dl-leucovorin 400 mg/m^2 administered via intravenous infusion over 2 hours
Other Names:
  • Folinic acid
Drug: Irinotecan
Irinotecan 180 mg/m^2 administered via intravenous infusion over 90 minutes
Drug: Fluorouracil
Fluorouracil 400 mg/m^2 administered via intravenous bolus and 2400 mg/m^2 via intravenous infusion over 46 hours
Experimental: FOLFIRI + SIM 700 mg (Part B)
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.
Biological: Simtuzumab
SIM administered via intravenous infusion over 30 minutes
Other Names:
  • SIM; GS-6624
Drug: Leucovorin
l-Leucovorin 200 mg/m^2 or dl-leucovorin 400 mg/m^2 administered via intravenous infusion over 2 hours
Other Names:
  • Folinic acid
Drug: Irinotecan
Irinotecan 180 mg/m^2 administered via intravenous infusion over 90 minutes
Drug: Fluorouracil
Fluorouracil 400 mg/m^2 administered via intravenous bolus and 2400 mg/m^2 via intravenous infusion over 46 hours
Experimental: FOLFIRI + Placebo (Part B)
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.
Drug: Leucovorin
l-Leucovorin 200 mg/m^2 or dl-leucovorin 400 mg/m^2 administered via intravenous infusion over 2 hours
Other Names:
  • Folinic acid
Drug: Irinotecan
Irinotecan 180 mg/m^2 administered via intravenous infusion over 90 minutes
Drug: Fluorouracil
Fluorouracil 400 mg/m^2 administered via intravenous bolus and 2400 mg/m^2 via intravenous infusion over 46 hours
Drug: Placebo to match SIM
Placebo to match SIM administered via intravenous infusion over 30 minutes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Randomization up to 27 months
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.
Randomization up to 27 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Randomization up to 33 months
The OS is measured as time from date of randomization to death regardless of cause. The OS was analyzed using KM estimates.
Randomization up to 33 months
Objective Response Rate (ORR)
Time Frame: Randomization up to 27 months
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.
Randomization up to 27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-295-0203
  • 2011-003754-61 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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