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Colorectal CancerPhase 2NCT01479465

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

A Phase 2 study testing Simtuzumab, Leucovorin and Irinotecan in people with Colorectal Cancer, run by Gilead Sciences at 109 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Simtuzumab, Leucovorin and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
266 participants
Where
109 sitesin 7 countries
Study dates
Dec 2011to Feb 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

109 sites in 7 countries.

109 sites in 7 countries

United States56 sites

  • Central Hematology Oncology Medical Group, Inc.

    Alhambra, California

  • Peachtree Hematology Oncology Consultants, PC

    Atlanta, Georgia

  • Comprehensive Blood and Cancer Center

    Bakersfield, California

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Dana Farber Cancer Institute

    Boston, Massachusetts

  • Providence Saint Joseph Medical Center-Disney Family Cancer Center

    Burbank, California

  • Northwestern University

    Chicago, Illinois

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio

  • South Carolina Oncology Associates

    Columbia, South Carolina

  • Wilshire Oncology Medical Group, Inc.

    Corona, California

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas

  • Virginal Cancer Specialists, PC

    Fairfax, Virginia, 22033

  • Center for Cancer and Blood Disorders, PC

    Fort Worth, Texas

  • Saint Jude Heritage Healthcare

    Fullerton, California

  • Florida Cancer Specialists

    Gainesville, Florida

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada

  • Clearview Cancer Institute

    Huntsville, Alabama, 35801

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana

  • West Michigan Cancer Center

    Kalamazoo, Michigan

  • University of California San Diego Medical Center

    La Jolla, California

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada

  • Suburban Hematology Oncology Associates, PC

    Lawrenceville, Georgia

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska

  • Pacific Shores Medical Group

    Long Beach, California

  • Comprehensive Hematology Oncology Centers, Inc.

    Los Angeles, California

  • TORI Network (Translational Oncology Research Intl)

    Los Angeles, California

  • UCLA Community Oncology Practice

    Los Angeles, California

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas

  • University of Wisconsin

    Madison, Wisconsin

  • Signal Point Clinical Research Center, LLC

    Middletown, Ohio

  • Virginia Cancer Institute

    Midlothian, Virginia

  • Montana Cancer Institute

    Missoula, Montana, 59802

  • Tennessee Oncology, PLLC

    Nashville, Tennessee

  • Yale University Smilow Cancer Hospital

    New Haven, Connecticut, 06520

  • New York University Clinical Cancer Center

    New York, New York, 10016

  • MD Anderson Cancer Center

    Orlando, Florida

  • Stanford University Medical Center

    Palo Alto, California

  • Wilshire Oncology Medical Group, Inc.

    Pomona, California

  • Kaiser Permanente Northwest Region Oncology Hematology

    Portland, Oregon

  • Cancer Care Associates Medical Group

    Redondo Beach, California

  • Pacific Shores Medical Group

    Redondo Beach, California

  • Virginia Cancer Institute

    Richmond, Virginia

  • Saint Joseph Oncology, Inc.

    Saint Joseph, Missouri

  • Utah Cancer Specialists

    Salt Lake City, Utah

  • Sharp Health Care

    San Diego, California

  • San Jose Medical Group

    San Jose, California

  • Central Coast Medical Oncology Corp

    Santa Maria, California

  • Seattle Cancer Care Alliance

    Seattle, Washington

  • Intermountain Healthcare

    St. George, Utah

  • Florida Cancer Specialists

    St. Petersburg, Florida

  • Scott & White Memorial

    Temple, Texas, 76508

  • Hematology and Oncology Associates at BridgePoint

    Tupelo, Mississippi

  • Georgetown University

    Washington D.C., District of Columbia

  • The Center for Cancer and Blood Disorders

    Weatherford, Texas

  • Oncology Hematology Care, Inc.

    Wilmington, Ohio

Other trials in United States

Germany13 sites

  • Medizinische Universitätsklinik Bochum

    Bochum, North Rhine-Westphalia, 44892

  • Universitätsklinikum Dresden

    Dresden, Saxony, 01307

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45122

  • Städtisches Klinikum Frankfurt-Höchst

    Frankfurt

  • Katholisches Marienkrankenhaus gGmbH

    Hamburg, 22045

  • Klinikum Region Hannover GmbH, Krankenhaus Siloah

    Hanover, Lower Saxony, 30449

  • Universitätsklinikum der Friedrich-Schiller-Universität Jena

    Jena, Thuringia, 07747

  • University Magdeburg

    Magdeburg

  • Universitätsklinikums Mannheim

    Mannheim, Baden-Wuerttenberg, 68167

  • Ludwig-Maximilians-Universität München Klinikum Großhadern

    München, Bavaria, 81377

  • Universitätsklinikum Rostock

    Rostock, Mecklenburg-Vorpommern, 18055

  • Krankenanstalt Mutterhaus der Borromäerinnen e.V.

    Trier, Rhineland-Palatinate, 54290

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Spain11 sites

  • Centro Oncológico Regional de Galicia

    A Coruña, La Coruna, 15009

  • Hospital Nuestra Señora de Sonsoles

    Ávila, 05004

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario de Girona Doctor Josep Trueta

    Girona, 17007

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clinico Universitario San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro

    Madrid, 28050

  • Hospital Universitario La Paz

    Madrid

  • Instituto de Investigación Sanitaria

    Madrid

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Russia9 sites

  • State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"

    Arkhangelsk

  • Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan

    Kazan'

  • Kursk Regional Oncologic Dispensary

    Kursk

  • Cancer Research Center n.a. Blokhin, Chemotherapy Dept.

    Moscow

  • Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD"

    Moscow

  • State Institution "Blokhin Cancer Research Centre RAMS"

    Moscow

  • Nizhny Novgorod City Oncology Dispensary

    Nizhny Novgorod

  • State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"

    Omsk

  • N.N.Petrov Research Institute of Oncology

    Saint Petersburg

Other trials in Russia

France8 sites

  • Centre Hospitalier Universitaire Estaing

    Clermont-Ferrand, Auvergne, 63003

  • Centre Georges François Leclerc

    Dijon

  • Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique

    Lille

  • Centre Hospitalier Régional Universitaire Hôpital Saint Eloi

    Montpellier

  • Centre Antoine Lacassagne

    Nice

  • Centre Eugène Marquis

    Rennes, Brittany Region, 35042

  • Institut Paoli Calmettes Centre Régional de Lutte Contre le Cancer

    Rennes

  • Hôpital Trousseau - Service de Gastroenterologie

    Tours

Other trials in France

Italy6 sites

  • Ospedale Unico Versilia

    Lido di Camaiore, Lucca, 55043

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Ospedale Niguarda Cà Granda

    Milan, 20162

  • Azienda Ospedaliera San Gerardo di Monza

    Monza, Monza E Brianza, 20052

  • Arcispedale Santa Maria Nuova IRCCS

    Reggio Emilia, Reggio Nella Emilia, 42100

  • Ospedale Civile SS Annunziata ASL 1

    Sassari, 07100

Other trials in Italy

Poland6 sites

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

    Bydgoszcz

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-952

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o.

    Krakow, Lesser Poland Voivodeship, 31-826

  • Olsztynski Osrodek Onkologiczny "Kopernik" sp. z o. o.

    Olsztyn, Warmian-Masurian Voivodeship, 10-513

  • Centralny Szpital Kliniczny MSWiA

    Warsaw

  • Centrum Onkologii - Instytut im Marii Sklodowskiej-Curie

    Warsaw

Other trials in Poland

About this study

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

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.

Being tested
Simtuzumab, Placebo to match SIM, Leucovorin, Irinotecan, Fluorouracil
Keywords
GSI, Gilead, Gilead Sciences, GS-6624, Colorectal Cancer, KRAS, Oncology, monoclonal antibody
Medical subject headings
Colorectal Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SimtuzumabBiological

    Also called SIM; GS-6624

    SIM administered via intravenous infusion over 30 minutes

  • Placebo to match SIMDrug

    Placebo to match SIM administered via intravenous infusion over 30 minutes

  • LeucovorinDrug

    Also called Folinic acid

    l-Leucovorin 200 mg/m^2 or dl-leucovorin 400 mg/m^2 administered via intravenous infusion over 2 hours

  • IrinotecanDrug

    Irinotecan 180 mg/m^2 administered via intravenous infusion over 90 minutes

  • FluorouracilDrug

    Fluorouracil 400 mg/m^2 administered via intravenous bolus and 2400 mg/m^2 via intravenous infusion over 46 hours

Study groups in NCT01479465
Study groupRoleWhat they receive
FOLFIRI + SIM 700 mg (Part A)ExperimentalParticipants 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.
Receives: Biological: Simtuzumab; Drug: Leucovorin; Drug: Irinotecan; Drug: Fluorouracil
FOLFIRI + SIM 200 mg (Part B)ExperimentalParticipants 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.
Receives: Biological: Simtuzumab; Drug: Leucovorin; Drug: Irinotecan; Drug: Fluorouracil
FOLFIRI + SIM 700 mg (Part B)ExperimentalParticipants 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.
Receives: Biological: Simtuzumab; Drug: Leucovorin; Drug: Irinotecan; Drug: Fluorouracil
FOLFIRI + Placebo (Part B)ExperimentalParticipants 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.
Receives: Drug: Placebo to match SIM; Drug: Leucovorin; Drug: Irinotecan; Drug: Fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Randomization up to 27 months

Secondary outcomes (2)

  1. 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.

    Measured: Randomization up to 33 months

  2. 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.

    Measured: Randomization up to 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionOct 2014
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01479465
Sponsor's protocol ID
GS-US-295-0203
Other IDs
2011-003754-61
Status last verified
Mar 2019
First submitted
9 Nov 2011
Last updated
17 Apr 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28246207

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Simtuzumab, Leucovorin and Irinotecan in people with Colorectal Cancer, run by Gilead Sciences at 109 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States, Germany, Spain, Russia, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Randomization up to 27 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01479465, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.

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