Spots Global Cancer Trial Database for A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer
Official Title: A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer
Study ID: NCT04322539
Study Description
Brief Summary: This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.
Detailed Description: This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib in combination with BSC versus placebo in combination with BSC in metastatic colorectal cancer participants who have progressed on, or were intolerant to, chemotherapy, anti-VEGF and anti-EGFR biologics, and TAS-102 or regorafenib. Participants with MSI-H/MMR deficient tumors must have also received an immune checkpoint inhibitor if approved and available and if deemed appropriate. Subjects with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available and if deemed appropriate. Metastatic colorectal cancer cannot be cured by surgery. Therefore, treatment principals are primarily aimed at controlling disease progression and prolonging survival. Standard first- and second-line therapy includes cytotoxic drugs such as 5-fluorouracil, oxaliplatin, and irinotecan; anti-VEGF therapy; and, if RAS wild type, anti-EGFR therapy. After the first two lines of chemotherapy, standard third-line treatment is either TAS-102 or regorafenib. There are currently no effective treatments for patients who have progressed on standard, approved therapies, and treatment options include reuse of prior therapies, clinical trials or BSC. Consequently, there is an unmet medical need for additional safe and effective treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Arizona, Phoenix, Arizona, United States
Arizona Oncology Associates, PC-HOPE, Tucson, Arizona, United States
California Research Institute (CRI), Los Angeles, California, United States
City of Hope Comprehensive Cancer Center, Los Angeles, California, United States
Rocky Mountain Cancer Center, Aurora, Colorado, United States
The George Washington University Medical Center, Washington, District of Columbia, United States
Sarah Cannon Research Institute-S-Ft. Myers (FCS South), Fort Myers, Florida, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
Cancer Care Centers of Brevard, Inc., Palm Bay, Florida, United States
Sarah Cannon Research Institute-N-St Pete (FCS North), Saint Petersburg, Florida, United States
Sarah Cannon Research Institute-Pan-Tallahassee (FCS Panhandle), Tallahassee, Florida, United States
Sarah Cannon Research-E-WPB (Florida Cancer Specialists-FCS East), West Palm Beach, Florida, United States
Emory Winship Cancer Institute, Atlanta, Georgia, United States
Illinois Cancer Specialists, Arlington Heights, Illinois, United States
Affiliated Oncologists, Chicago Ridge, Illinois, United States
University of Chicago Medical Center, Chicago, Illinois, United States
XCancer / Central Care Cancer Center, Garden City, Kansas, United States
University of Louisville - James Brown Cancer Center, Louisville, Kentucky, United States
Norton Cancer Institute Audubon, Louisville, Kentucky, United States
Hematology Oncology Clinic, Baton Rouge, Louisiana, United States
XCancer / Pontchartrain Cancer Center, Hammond, Louisiana, United States
Maryland Oncology Hematology, P.A., Columbia, Maryland, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Minnesota Oncology, Minneapolis, Minnesota, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Center for Pharmaceutical Research, Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
XCancer / New Mexico Oncology & Hematology Consultants, Albuquerque, New Mexico, United States
Charleston Oncology, Charleston, South Carolina, United States
Sarah Cannon Tennessee Oncology, Nashville, Tennessee, United States
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
Texas Oncology - Austin, Austin, Texas, United States
Texas Oncology Baylor Sammons, Dallas, Texas, United States
Texas Oncology-El Paso, El Paso, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Texas Oncology-McAllen, McAllen, Texas, United States
Texas Oncology-San Antonio, San Antonio, Texas, United States
Texas Oncology-Tyler, Tyler, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Providence Regional Cancer Partnership, Everett, Washington, United States
Northwest Cancer Specialists, P.C., Vancouver, Washington, United States
Medical College of Wisconsin/ Froedtert Hospital, Milwaukee, Wisconsin, United States
Integrated Clinical Oncology Network Pty Ltd (Icon), Brisbane, Queensland, Australia
The Queen Elizabeth Hospital, Adelaide, South Australia, Australia
Flinders Medical Centre, Adelaide, South Australia, Australia
Western Health, Melbourne, Victoria, Australia
Austin Hopistal Medical Oncology Unit, Melbourne, Victoria, Australia
Monash Health, Melbourne, Victoria, Australia
Ordensklinikum Linz Barmherzige Schwestern, Linz, AUT, Austria
Schwerpunktkrankenhaus Feldkirch, Rankweil, AUT, Austria
Klinikum Steyr, Steyr, AUT, Austria
Klinikum Wels-Grieskirchen GmbH, Wels, AUT, Austria
Landesklinikum Wiener Neustadt, Wiener Neustadt, AUT, Austria
Wiener Gesundheitsverbund - Klinik Ottakring, Wien, AUT, Austria
Onze-Lieve-Vrouwziekenhuis OLV - Campus Aalst, Aalst, BEL, Belgium
UCL St-Luc, Brussels, BEL, Belgium
Grand Hopital de Charleroi, Charleroi, BEL, Belgium
UZ Antwerpen, Edegem, BEL, Belgium
Centres Hospitaliers Jolimont, Haine-Saint-Paul, BEL, Belgium
UZ Leuven, Leuven, BEL, Belgium
AZ Delta Roeselare, Roeselare, BEL, Belgium
AZ Turnhout, Turnhout, BEL, Belgium
CHU Mont-Godinne, Yvoir, BEL, Belgium
Clinique CHC MontLegia, Liège, Wallonia, Belgium
CHU de Lige - Domaine Universitaire du Sart Tilman, Liège, Wallonia, Belgium
Masaryk Memorial Cancer Institute, Hematoonkologie, Brno, Moravia, Czechia
Fakultni nemocnice Olomouc, Onkologicka klinika, Olomouc, Moravia, Czechia
Vseobecna Fakultni Nemocnice VFN, Onkologicka Klinika, Prague, , Czechia
East Tallinn Central Hospital Centre of Oncology, Tallinn, Harju, Estonia
Sihtasutus Pohja-Eesti Regionaalhaigla (PERH) (North Estonia Medical Centre), Tallinn, Harju, Estonia
Tartu University Hospital Clinic of Haematology and Oncology, Tartu, , Estonia
CHU Besancon, Besançon, Franche-Comte, France
Institut Bergonie, Bordeaux, FRA, France
Unicancer, Caen, FRA, France
Centre Georges-Francois Leclerc, Dijon, FRA, France
ICM-Val d'Aurelle, Montpellier, FRA, France
Saint-Louis Hospital, Paris, FRA, France
Hopital St Antoine, Paris, FRA, France
Hopital Pitie Salptriere, Paris, FRA, France
CHU Poitiers, Poitiers, FRA, France
Centre hospitalier Annecy Genevois, Pringy, FRA, France
Centre Hospitalier Universitaire CHU de Rennes - Hopital de Pontchaillou, Rennes, FRA, France
Institut de cancerologie Strasbourg-Europe, Strasbourg, FRA, France
Institut Gustave Roussy, Villejuif, Paris, France
Universitaetsklinikum Erlangen, Erlangen, Bavaria, Germany
HELIOS Klinikum Berlin-Buch Saarow, Berlin, DEU, Germany
Charite - Universitaetsmedizin Berlin, Berlin, DEU, Germany
Universitaetsklinik Dresden, Dresden, DEU, Germany
University Hospital Essen, Essen, DEU, Germany
Institut fr Klinisch Onkologische ForschungKrankenhaus Nordwest GmbH, Frankfurt Am Main, DEU, Germany
Haematologisch-Onkologische Praxis Hamburg Eppendorf, Hamburg, DEU, Germany
Asklepios Tumorzentrum Hamburg AK Altona, Hamburg, DEU, Germany
Universitaeres Krebszentrum Leipzig, Leipzig, DEU, Germany
RKH Kliniken, Ludwigsburg, DEU, Germany
Universitaetsmedizin Mannheim- III. Medizinische Klinik, Mannheim, DEU, Germany
Klinikum Neuperlach, Muenchen, DEU, Germany
Zentrum für Hämatologie und Onkologie MVZ GmbH, Porta Westfalica, DEU, Germany
Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet, Szent Laszlo Korhaz, Budapest, HUN, Hungary
National Institute of Oncology, Budapest, HUN, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, HUN, Hungary
Debreceni Egyetem Klinikai Kozpont, Debrecen, HUN, Hungary
Bacs- Kiskun Megyei Korhaz, Kecskemét, HUN, Hungary
Szabolcs-Szatmar-Bereg megyei Korhazak es Egyetemi Oktatokorhaz, Nyiregyhaza, HUN, Hungary
Hetenyi G Korhaz, Onkologiai Kozpont, Szolnok, HUN, Hungary
Szent Borbala Korhaz, Tatabanya, HUN, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz, Klinikai Onkologiai Osztaly, Kaposvár, Somogy, Hungary
Zala Megyei Szent Rafael Korhaz, Onkologiai Osztaly, F epulet 3. em., Zalaegerszeg, Zala, Hungary
Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Megyei Onkologiai Kozpont, Gyula, , Hungary
Fondazione Poliambulanza Hospital, Brescia, ITA, Italy
Policlinico San Martino di Genova, Genova, ITA, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, ITA, Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, ITA, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, ITA, Italy
Istituto Oncologico Veneto Irccs, Padova, ITA, Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, ITA, Italy
Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, ITA, Italy
AO Card G Panico, Tricase, ITA, Italy
Ospedale San Bortolo Azienda ULSS8 Berica - Distretto Est, Vicenza, ITA, Italy
Istituto Clinico Humanitas, Rozzano MI, Lombardy, Italy
Aichi Cancer Center, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
Shikoku Cancer Center, Matsuyama City, Ehime, Japan
Kyushu Cancer Center, Fukuoka-shi, Fukuoka, Japan
Hokkaido University Hospital, Sapporo-shi, Hokkaido, Japan
St. Marianna University School of Medicine Hospital, Kawasaki-shi, Kanagawa, Japan
Kindai University Hospital, Osakasayama-shi, Osaka, Japan
Osaka University Hospital, Suita-shi, Osaka, Japan
Shizuoka Cancer Center, Shizuoka, Sunto-gun, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
M Sklodowska Curie Memorial Cancer Center, Klinika Gastroenterologii Onkologicznej, Warszawa, Masovia, Poland
Bialostockie Centrum Onkologii im. Marii Skodowskiej-Curie, Bialystok, Podlaskie, Poland
Hospital Universitari Vall dHebron, Barcelona, ESP, Spain
Hospital Universitario Reina Sofa, Córdoba, ESP, Spain
Hospital General Universitario de Elche, Elche, ESP, Spain
Hospital Universitario Ramón y Cajal, Madrid, ESP, Spain
Hospital Clinico San Carlos, Madrid, ESP, Spain
Hospital Universitario 12 de Octubre, Madrid, ESP, Spain
Hospital Universitario La Paz, Madrid, ESP, Spain
Hospital Universitario HM Sanchinarro, Madrid, ESP, Spain
Hospital Universitario Puerta de Hierro, Majadahonda, ESP, Spain
Hospital Regional Universitario Carlos Haya, Malaga, ESP, Spain
Hospital Universitario Central de Asturias, Oviedo, ESP, Spain
Hospital Universitario Marques de Valdecilla, Santander, ESP, Spain
Hospital ClÃ-nico Universitario de Santiago-CHUS, Santiago De Compostela, ESP, Spain
Hospital General Universitario Gregorio Maranon HGUGM, Madrid, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Aberdeen Royal Infirmary, Aberdeen, GBR, United Kingdom
The Royal Marsden Hospital, London, GBR, United Kingdom
Sarah Cannon Research Institute UK, London, Middlesex, United Kingdom
Contact Details
Name: William Schelman, MD, PhD
Affiliation: HUTCHMED International Corporation
Role: STUDY_DIRECTOR
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