Clinical trial NCT04322539: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Colorectal Cancer
Metastatic Colon Cancer
Keywords: colon
colorectal
mcrc
crc
metastatic colon
metastatic colorectal
VEGF
VEGFR
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2020-03-26
Enrollment: 691
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: Inclusion Criteria:

* Provide written informed consent;
* Age ≥18 years;
* Histologically and/or cytologically documented metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability microsatellite instability (MSI)/mismatch repair (MMR) status for each patient must be documented, according to country level guidelines;
* Participants must have progressed on or been intolerant to treatment with either trifluridine/tipiracil (TAS-102) or regorafenib. Participants are considered intolerant to TAS-102 or regorafenib if they have received at least 1 dose of either agents and were discontinued from therapy for reasons other than disease progression. Participants who have been treated with both TAS-102 and regorafenib are permitted. Participants must also have been previously treated with standard approved therapies: fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy;
* Participants with microsatellite-high (MSI-H) or mismatch repair deficient (dMMR) tumors must have been treated with immune checkpoint inhibitors if approved and available in the participant's country unless the patient is ineligible for treatment with a checkpoint inhibitor;
* Participants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxaliplatin in the metastatic setting. Participants who developed metastatic disease more than 6 months after completion of oxaliplatin-containing adjuvant treatment must be treated with oxaliplatin-based therapy in the metastatic setting to be eligible;
* Body weight ≥40kg;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
* Have measurable disease according to RECIST Version 1.1, assessed locally. Tumors that were treated with radiotherapy are not measurable per RECIST Version 1.1, unless there has been documented progression of those lesions;
* Expected survival \>12 weeks.
* For female participants of childbearing potential and male participants with partners of childbearing potential, agreement to use a highly effective form(s) of contraception, that results in a low failure rate (\<1% per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire study period, and for 90 days after taking the last dose of study drug. Such methods include: oral hormonal contraception (combined estrogen/ progestogen, or progestogen-only) associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the participant. Highly effective contraception should always be combined with an additional barrier method (eg, diaphragm, with spermicide). The same criteria are applicable to male participants involved in this clinical trial if they have a partner of childbirth potential, and male participants must always use a condom.
* Participants with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available in the participant's home country unless the patient is ineligible for treatment with a BRAF inhibitor.

Exclusion Criteria:

* Absolute neutrophil count (ANC) \<1.5×109/L, platelet count \<100×109/L, or hemoglobin \<9.0 g/dL. Blood transfusion within 1 week prior to enrollment for the purpose of increasing the likelihood of eligibility is not allowed;
* Serum total bilirubin \>1.5 × the upper limit of normal (ULN). Participants with Gilbert syndrome, bilirubin \<2 X ULN, and normal AST/ALT are eligible;
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 × ULN in participants without hepatic metastases; ALT or AST \>5 × ULN in participants with hepatic metastases;
* Serum creatinine \>1.5 × ULN or creatinine clearance \<60 mL/min. Creatinine clearance can either be measured in a 24-hour urine collection or estimated by the Cockroft-Gault equation.
* Urine dipstick protein ≥2+ or 24-hour urine protein ≥1.0 g/24-h. Participants with greater than 2+ proteinuria by dipstick must undergo a 24-hour urine collection to assess urine protein level;
* Uncontrolled hypertension, defined as: systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg despite optimal medical management. Participants were required to have blood pressure values below both limits. Repeated assessments were permitted;
* International Normalized Ratio (INR) \>1.5 x ULN or activated partial thromboplastin time (aPTT) \>1.5 × ULN, unless the patient is currently receiving or intended to receive anticoagulants for prophylactic purposes;
* History of, or active gastric/duodenal ulcer or ulcerative colitis, active hemorrhage of an unresected gastrointestinal tumor, history of perforation or fistulas; or any other condition that could, in the investigator's judgment, result in gastrointestinal hemorrhage or perforation; within the 6 months prior to screening;
* History or presence of hemorrhage from any other site (eg, hemoptysis or hematemesis) within 2 months prior to screening;
* History of a thromboembolic event, including deep vein thrombosis (DVT), pulmonary embolism (PE), or arterial embolism within 6 months prior to screening.
* Stroke and/or transient ischemic attack within 12 months prior to screening;
* Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass surgery within 6 months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment, or left ventricular ejection fraction (LVEF) \<50% by echocardiogram;
* Mean corrected QT interval using the Fridericia method (QTcF) \>480 msec or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in a first-degree relative.
* Concomitant medications with a known risk of causing QT prolongation and/or Torsades de Pointes.
* Systemic anti-neoplastic therapies (except for those described in Exclusion 18) or any investigational therapy within 4 weeks prior to the first dose of study drug, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy and immunotherapy;
* Systemic small molecule targeted therapies (eg, tyrosine kinase inhibitors) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug;
* Palliative radiotherapy for bone metastasis/lesion within 2 weeks prior to the initiation of study drug;
* Brachytherapy (i.e., implantation of radioactive seeds) within 60 days prior to the first dose of study drug.
* Use of strong inducers or inhibitors of CYP3A4 within 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study drug;
* Surgery or invasive procedure (i.e., a procedure that includes a biopsy; central venous catheter placement is allowed) within 60 days prior to the first dose of study drug or unhealed surgical incision;
* Any unresolved toxicities from a previous antitumor treatment greater than CTCAE v5.0 Grade 1 (except for alopecia or neurotoxicity grade≤2);
* Known human immunodeficiency virus (HIV) infection;
* Known history of active viral hepatitis. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
* Clinically uncontrolled active infection requiring IV antibiotics;
* Tumor invasion of a large vascular structure, eg, pulmonary artery, superior or inferior vena cava;
* Women who are pregnant or lactating;
* Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease for 14 days or longer; participants requiring steroids within 4 weeks prior to start of study treatment are excluded;
* Other malignancy, except for non-melanoma skin cancer, in situ cervical ca or bladder ca (Tis and T1) that have been adequately treated during the 5 years prior to screening;
* Inability to take medication orally, dysphagia or an active gastric ulcer resulting from previous surgery (eg, gastric bypass) or a severe gastrointestinal disease, or any other condition that investigators believe may affect absorption of the investigational product;
* Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition (e.g., current alcohol or drug abuse) that investigators suspect may prohibit use of the investigational product, affect interpretation of study results, or put the patient at undue risk of harm based on the investigator's assessment;
* Known hypersensitivity to fruquintinib (or placebo) or any of its inactive ingredients including the azo dyes Tartrazine - FD\&C Yellow 5 and Sunset yellow FCF - FD\&C Yellow 6;
* Participants who have received prior fruquintinib;
* Live vaccine \<28days before the first dose of study drug(s). Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From date of randomization to death from any cause (up to 22 months)
Secondary outcomes:
measure: Progression Free Survival (PFS), as Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
timeFrame: From randomization until the first documentation of objective progression or death, whichever comes first (up to 22 months)
measure: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: From randomization until the first documentation of best overall response (up to 22 months)
measure: Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: From randomization until the first documentation of best overall response (up to 22 months)
measure: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: From first occurrence of PR or CR until the first documentation progression or death, whichever comes first (up to 22 months
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: From start of study drug administration up to approximately 40 months
measure: Observed Plasma Concentrations of Fruquintinib and Metabolite M11
timeFrame: Cycle 1 (Day 1 and 21): Pre-dose, 1, 2, 3 and 4 hours; Cycle 2 (Day 21): Predose and 2 hours, Cycle 3 (Day 1): Pre-dose, Cycle 3 (Day 21): Pre-dose and 2 hours, Cycle 5, 7, 9, 11, 13, 15 and 17 (Day 1): Pre-dose (Each cycle = 28 days)
measure: Change From Baseline of Electrocardiogram (ECG) Results - QTcF Intervals Using Fridericia's Formula
timeFrame: Baseline, Cycle 1 (Day 1 and 21): Pre-dose, 1, 2, 3 and 4 hours; Cycle 2 and 3 (Day 21): Pre-dose (Each cycle = 28 days)
measure: Change From Baseline of ECG Results -QTcB Intervals Using Bazzett's Formula
timeFrame: Baseline, Cycle 1 (Day 1 and 21): Pre-dose, 1, 2, 3 and 4 hours; Cycle 2 and 3 (Day 21): Pre-dose (Each cycle = 28 days)
measure: Correlation Between Fruquintinib Exposure (CminSS) and Efficacy Parameters (OS)
timeFrame: Up to 22 months
measure: Correlation Between Fruquintinib Exposure (CmaxSS) and Safety Parameters (Any Grade [Gr] and Grade 3+ (Gr3+): Dermatological Toxicity, Proteinuria and Gr Hemorrhage)
timeFrame: Up to 22 months
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale Score
timeFrame: Baseline, Cycle 2, 3 and 4 (Each cycle=28 days)
measure: Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
timeFrame: Baseline, Cycle 2, 3 and 4 (Each cycle=28 days)
measure: Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Health Utility Index Scores
timeFrame: Baseline, Cycle 2, 3 and 4 (Each cycle=28 days)
measure: Health Care Resource Utilization: Duration of Hospital Visits by Participants
timeFrame: From start of study drug administration up to 22 months
measure: Health Care Resource Utilization: Number of Participants With Any Concomitant Medications Prescribed
timeFrame: From start of study drug administration up to 22 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC-HOPE
state: Arizona
city: Los Angeles
country: United States
facility: California Research Institute (CRI)
state: California
city: Los Angeles
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Washington
country: United States
facility: The George Washington University Medical Center
state: District of Columbia
city: Fort Myers
country: United States
facility: Sarah Cannon Research Institute-S-Ft. Myers (FCS South)
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Palm Bay
country: United States
facility: Cancer Care Centers of Brevard, Inc.
state: Florida
city: Saint Petersburg
country: United States
facility: Sarah Cannon Research Institute-N-St Pete (FCS North)
state: Florida
city: Tallahassee
country: United States
facility: Sarah Cannon Research Institute-Pan-Tallahassee (FCS Panhandle)
state: Florida
city: West Palm Beach
country: United States
facility: Sarah Cannon Research-E-WPB (Florida Cancer Specialists-FCS East)
state: Florida
city: Atlanta
country: United States
facility: Emory Winship Cancer Institute
state: Georgia
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Chicago Ridge
country: United States
facility: Affiliated Oncologists
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Garden City
country: United States
facility: XCancer / Central Care Cancer Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville - James Brown Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute Audubon
state: Kentucky
city: Baton Rouge
country: United States
facility: Hematology Oncology Clinic
state: Louisiana
city: Hammond
country: United States
facility: XCancer / Pontchartrain Cancer Center
state: Louisiana
city: Columbia
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Albuquerque
country: United States
facility: XCancer / New Mexico Oncology & Hematology Consultants
state: New Mexico
city: Charleston
country: United States
facility: Charleston Oncology
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Tennessee Oncology
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Austin
state: Texas
city: Dallas
country: United States
facility: Texas Oncology Baylor Sammons
state: Texas
city: El Paso
country: United States
facility: Texas Oncology-El Paso
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: McAllen
country: United States
facility: Texas Oncology-McAllen
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology-San Antonio
state: Texas
city: Tyler
country: United States
facility: Texas Oncology-Tyler
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/ Froedtert Hospital
state: Wisconsin
city: Brisbane
country: Australia
facility: Integrated Clinical Oncology Network Pty Ltd (Icon)
state: Queensland
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Melbourne
country: Australia
facility: Western Health
state: Victoria
city: Melbourne
country: Australia
facility: Austin Hopistal Medical Oncology Unit
state: Victoria
city: Melbourne
country: Australia
facility: Monash Health
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz Barmherzige Schwestern
state: AUT
city: Rankweil
country: Austria
facility: Schwerpunktkrankenhaus Feldkirch
state: AUT
city: Steyr
country: Austria
facility: Klinikum Steyr
state: AUT
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
state: AUT
city: Wiener Neustadt
country: Austria
facility: Landesklinikum Wiener Neustadt
state: AUT
city: Wien
country: Austria
facility: Wiener Gesundheitsverbund - Klinik Ottakring
state: AUT
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis OLV - Campus Aalst
state: BEL
city: Brussels
country: Belgium
facility: UCL St-Luc
state: BEL
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi
state: BEL
city: Edegem
country: Belgium
facility: UZ Antwerpen
state: BEL
city: Haine-Saint-Paul
country: Belgium
facility: Centres Hospitaliers Jolimont
state: BEL
city: Leuven
country: Belgium
facility: UZ Leuven
state: BEL
city: Roeselare
country: Belgium
facility: AZ Delta Roeselare
state: BEL
city: Turnhout
country: Belgium
facility: AZ Turnhout
state: BEL
city: Yvoir
country: Belgium
facility: CHU Mont-Godinne
state: BEL
city: Liège
country: Belgium
facility: Clinique CHC MontLegia
state: Wallonia
city: Liège
country: Belgium
facility: CHU de Lige - Domaine Universitaire du Sart Tilman
state: Wallonia
city: Brno
country: Czechia
facility: Masaryk Memorial Cancer Institute, Hematoonkologie
state: Moravia
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc, Onkologicka klinika
state: Moravia
city: Prague
country: Czechia
facility: Vseobecna Fakultni Nemocnice VFN, Onkologicka Klinika
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital Centre of Oncology
state: Harju
city: Tallinn
country: Estonia
facility: Sihtasutus Pohja-Eesti Regionaalhaigla (PERH) (North Estonia Medical Centre)
state: Harju
city: Tartu
country: Estonia
facility: Tartu University Hospital Clinic of Haematology and Oncology
city: Besançon
country: France
facility: CHU Besancon
state: Franche-Comte
city: Bordeaux
country: France
facility: Institut Bergonie
state: FRA
city: Caen
country: France
facility: Unicancer
state: FRA
city: Dijon
country: France
facility: Centre Georges-Francois Leclerc
state: FRA
city: Montpellier
country: France
facility: ICM-Val d'Aurelle
state: FRA
city: Paris
country: France
facility: Saint-Louis Hospital
state: FRA
city: Paris
country: France
facility: Hopital St Antoine
state: FRA
city: Paris
country: France
facility: Hopital Pitie Salptriere
state: FRA
city: Poitiers
country: France
facility: CHU Poitiers
state: FRA
city: Pringy
country: France
facility: Centre hospitalier Annecy Genevois
state: FRA
city: Rennes
country: France
facility: Centre Hospitalier Universitaire CHU de Rennes - Hopital de Pontchaillou
state: FRA
city: Strasbourg
country: France
facility: Institut de cancerologie Strasbourg-Europe
state: FRA
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Paris
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
state: Bavaria
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch Saarow
state: DEU
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin
state: DEU
city: Dresden
country: Germany
facility: Universitaetsklinik Dresden
state: DEU
city: Essen
country: Germany
facility: University Hospital Essen
state: DEU
city: Frankfurt Am Main
country: Germany
facility: Institut fr Klinisch Onkologische ForschungKrankenhaus Nordwest GmbH
state: DEU
city: Hamburg
country: Germany
facility: Haematologisch-Onkologische Praxis Hamburg Eppendorf
state: DEU
city: Hamburg
country: Germany
facility: Asklepios Tumorzentrum Hamburg AK Altona
state: DEU
city: Leipzig
country: Germany
facility: Universitaeres Krebszentrum Leipzig
state: DEU
city: Ludwigsburg
country: Germany
facility: RKH Kliniken
state: DEU
city: Mannheim
country: Germany
facility: Universitaetsmedizin Mannheim- III. Medizinische Klinik
state: DEU
city: Muenchen
country: Germany
facility: Klinikum Neuperlach
state: DEU
city: Porta Westfalica
country: Germany
facility: Zentrum für Hämatologie und Onkologie MVZ GmbH
state: DEU
city: Budapest
country: Hungary
facility: Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet, Szent Laszlo Korhaz
state: HUN
city: Budapest
country: Hungary
facility: National Institute of Oncology
state: HUN
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
state: HUN
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
state: HUN
city: Kecskemét
country: Hungary
facility: Bacs- Kiskun Megyei Korhaz
state: HUN
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg megyei Korhazak es Egyetemi Oktatokorhaz
state: HUN
city: Szolnok
country: Hungary
facility: Hetenyi G Korhaz, Onkologiai Kozpont
state: HUN
city: Tatabanya
country: Hungary
facility: Szent Borbala Korhaz
state: HUN
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Klinikai Onkologiai Osztaly
state: Somogy
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz, Onkologiai Osztaly, F epulet 3. em.
state: Zala
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Megyei Onkologiai Kozpont
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Hospital
state: ITA
city: Genova
country: Italy
facility: Policlinico San Martino di Genova
state: ITA
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: ITA
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: ITA
city: Naples
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
state: ITA
city: Padova
country: Italy
facility: Istituto Oncologico Veneto Irccs
state: ITA
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: ITA
city: Reggio Emilia
country: Italy
facility: Azienda USL-IRCCS di Reggio Emilia
state: ITA
city: Tricase
country: Italy
facility: AO Card G Panico
state: ITA
city: Vicenza
country: Italy
facility: Ospedale San Bortolo Azienda ULSS8 Berica - Distretto Est
state: ITA
city: Rozzano MI
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardy
city: Nagoya
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama City
country: Japan
facility: Shikoku Cancer Center
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kyushu Cancer Center
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kawasaki-shi
country: Japan
facility: St. Marianna University School of Medicine Hospital
state: Kanagawa
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
state: Sunto-gun
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Warszawa
country: Poland
facility: M Sklodowska Curie Memorial Cancer Center, Klinika Gastroenterologii Onkologicznej
state: Masovia
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii im. Marii Skodowskiej-Curie
state: Podlaskie
city: Barcelona
country: Spain
facility: Hospital Universitari Vall dHebron
state: ESP
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofa
state: ESP
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: ESP
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: ESP
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
state: ESP
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: ESP
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
state: ESP
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
state: ESP
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: ESP
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
state: ESP
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: ESP
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: ESP
city: Santiago De Compostela
country: Spain
facility: Hospital ClÃ-nico Universitario de Santiago-CHUS
state: ESP
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon HGUGM
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: GBR
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
state: GBR
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
state: Middlesex
Study officials:
affiliation: HUTCHMED International Corporation
name: William Schelman, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Dasari A, Sobrero A, Yao J, Yoshino T, Schelman W, Yang Z, Chien C, Kania M, Tabernero J, Eng C. FRESCO-2: a global Phase III study investigating the efficacy and safety of fruquintinib in metastatic colorectal cancer. Future Oncol. 2021 Aug;17(24):3151-3162. doi: 10.2217/fon-2021-0202. Epub 2021 May 17.