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FRESCO-2: A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Patients With Metastatic Colorectal Cancer

Sponsor
Hutchison Medipharma Limited (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04322539
Collaborator
(none)
691
Enrollment
153
Locations
2
Arms
25.7
Anticipated Duration (Months)
4.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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 patients with refractory metastatic colorectal cancer (mCRC). Approximately 687 subjects will be randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 advanced colorectal cancer patients who have progressed on, or were intolerant to, chemotherapy, biologics, and TAS-102 or regorafenib. Patients 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
691 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 10, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: fruquintinib plus best supportive care

In this arm, subjects will receive active study drug plus best supportive care

Drug: Fruquintinib
Oral VEGFR inhibitor
Other Names:
  • HMPL-013

    		•
    Placebo Comparator: placebo plus best supportive care

    In this arm, subjects will receive placebo plus best supportive care

    Drug: Placebo
    Placebo capsule

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [up to 10 years]

      To evaluate the overall survival of fruquintinib plus BSC compared to placebo plus BSC in subjects with refractory mCRC.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    • Subjects must have progressed on or been intolerant to treatment with either trifluridine/tipiracil (TAS-102) or regorafenib. Subjects 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. Subjects who have been treated with both TAS-102 and regorafenib are permitted. Subjects 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;

    • Subjects 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 subject's country unless the patient is ineligible for treatment with a checkpoint inhibitor;

    • Subjects 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. Subjects 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 subjects of childbearing potential and male subjects 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 subject. Highly effective contraception should always be combined with an additional barrier method (eg, diaphragm, with spermicide). The same criteria are applicable to male subjects involved in this clinical trial if they have a partner of childbirth potential, and male subjects must always use a condom.

    • Subjects with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available in the subject'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). Patients with Gilbert syndrome, bilirubin <2 X ULN, and normal AST/ALT are eligible;

    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 × ULN in patients without hepatic metastases; ALT or AST >5 × ULN in patients 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. Subjects 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;

    • 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 patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients 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; patients 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;

    • Subjects 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Arizona Phoenix Arizona United States 85054
    2 Arizona Oncology Associates, PC-HOPE Tucson Arizona United States 85704
    3 California Research Institute (CRI) Los Angeles California United States 90027
    4 City of Hope Comprehensive Cancer Center Los Angeles California United States 91010
    5 Rocky Mountain Cancer Center Aurora Colorado United States 80012
    6 The George Washington University Medical Center Washington District of Columbia United States 20052
    7 Sarah Cannon Research Institute-S-Ft. Myers (FCS South) Fort Myers Florida United States 33901
    8 Mayo Clinic Florida Jacksonville Florida United States 32224
    9 Mount Sinai Medical Center Miami Beach Florida United States 33140
    10 Cancer Care Centers of Brevard, Inc. Palm Bay Florida United States 32901
    11 Sarah Cannon Research Institute-N-St Pete (FCS North) Saint Petersburg Florida United States 33705
    12 Sarah Cannon Research Institute-Pan-Tallahassee (FCS Panhandle) Tallahassee Florida United States 32308
    13 Sarah Cannon Research-E-WPB (Florida Cancer Specialists-FCS East) West Palm Beach Florida United States 33401
    14 Emory Winship Cancer Institute Atlanta Georgia United States 30322
    15 Illinois Cancer Specialists Arlington Heights Illinois United States 60005
    16 Affiliated Oncologists Chicago Ridge Illinois United States 60415
    17 University of Chicago Medical Center Chicago Illinois United States 60637
    18 XCancer / Central Care Cancer Center Garden City Kansas United States 67846
    19 University of Louisville - James Brown Cancer Center Louisville Kentucky United States 40202
    20 Norton Cancer Institute Audubon Louisville Kentucky United States 40217
    21 Hematology Oncology Clinic Baton Rouge Louisiana United States 70809
    22 XCancer / Pontchartrain Cancer Center Hammond Louisiana United States 70403
    23 Maryland Oncology Hematology, P.A. Columbia Maryland United States 21044
    24 University of Michigan Health System Ann Arbor Michigan United States 48109
    25 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    26 Minnesota Oncology Minneapolis Minnesota United States 55404
    27 Mayo Clinic Rochester Rochester Minnesota United States 55905
    28 Center for Pharmaceutical Research Kansas City Missouri United States 64114
    29 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89169
    30 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
    31 XCancer / New Mexico Oncology & Hematology Consultants Albuquerque New Mexico United States 87109
    32 Charleston Oncology Charleston South Carolina United States 29414
    33 Sarah Cannon Tennessee Oncology Nashville Tennessee United States 37203
    34 Vanderbilt Ingram Cancer Center Nashville Tennessee United States 37232
    35 Texas Oncology - Austin Austin Texas United States 78705
    36 Texas Oncology Baylor Sammons Dallas Texas United States 75246
    37 Texas Oncology-El Paso El Paso Texas United States 79902
    38 MD Anderson Cancer Center Houston Texas United States 77030
    39 Texas Oncology-McAllen McAllen Texas United States 78503
    40 Texas Oncology-San Antonio San Antonio Texas United States 78217
    41 Texas Oncology-Tyler Tyler Texas United States 75702
    42 Virginia Oncology Associates Norfolk Virginia United States 23502
    43 Providence Regional Cancer Partnership Everett Washington United States 98201
    44 Northwest Cancer Specialists, P.C. Vancouver Washington United States 98684
    45 Medical College of Wisconsin/ Froedtert Hospital Milwaukee Wisconsin United States 53226
    46 Integrated Clinical Oncology Network Pty Ltd (Icon) Brisbane Queensland Australia 4001
    47 The Queen Elizabeth Hospital Adelaide South Australia Australia 5011
    48 Flinders Medical Centre Adelaide South Australia Australia 5042
    49 Western Health Melbourne Victoria Australia 3021
    50 Austin Hopistal Medical Oncology Unit Melbourne Victoria Australia 3084
    51 Monash Health Melbourne Victoria Australia 3168
    52 Ordensklinikum Linz Barmherzige Schwestern Linz AUT Austria 4010
    53 Schwerpunktkrankenhaus Feldkirch Rankweil AUT Austria 6830
    54 Klinikum Steyr Steyr AUT Austria 4400
    55 Klinikum Wels-Grieskirchen GmbH Wels AUT Austria 4600
    56 Landesklinikum Wiener Neustadt Wiener Neustadt AUT Austria 2700
    57 Wiener Gesundheitsverbund - Klinik Ottakring Wien AUT Austria 1160
    58 Onze-Lieve-Vrouwziekenhuis OLV - Campus Aalst Aalst BEL Belgium 9300
    59 UCL St-Luc Brussels BEL Belgium 1200
    60 Grand Hopital de Charleroi Charleroi BEL Belgium 6000
    61 UZ Antwerpen Edegem BEL Belgium 2650
    62 Centres Hospitaliers Jolimont Haine-Saint-Paul BEL Belgium 7100
    63 UZ Leuven Leuven BEL Belgium 3000
    64 AZ Delta Roeselare Roeselare BEL Belgium 8800
    65 AZ Turnhout Turnhout BEL Belgium 2300
    66 CHU Mont-Godinne Yvoir BEL Belgium 5530
    67 Clinique CHC MontLegia Liège Wallonia Belgium 4000
    68 CHU de Lige - Domaine Universitaire du Sart Tilman Liège Wallonia Belgium 4001
    69 Masaryk Memorial Cancer Institute, Hematoonkologie Brno Moravia Czechia 60200
    70 Fakultni nemocnice Olomouc, Onkologicka klinika Olomouc Moravia Czechia 77900
    71 Vseobecna Fakultni Nemocnice VFN, Onkologicka Klinika Prague Czechia 12808
    72 East Tallinn Central Hospital Centre of Oncology Tallinn Harju Estonia 11312
    73 Sihtasutus Pohja-Eesti Regionaalhaigla (PERH) (North Estonia Medical Centre) Tallinn Harju Estonia 13419
    74 Tartu University Hospital Clinic of Haematology and Oncology Tartu Estonia 50406
    75 CHU Besancon Besançon Franche-Comte France 25000
    76 Institut Bergonie Bordeaux FRA France 33000
    77 Unicancer Caen FRA France 14000
    78 Centre Georges-Francois Leclerc Dijon FRA France 21000
    79 ICM-Val d'Aurelle Montpellier FRA France 34298
    80 Saint-Louis Hospital Paris FRA France 75010
    81 Hopital St Antoine Paris FRA France 75012
    82 Hopital Pitie Salptriere Paris FRA France 75013
    83 CHU Poitiers Poitiers FRA France 86000
    84 Centre hospitalier Annecy Genevois Pringy FRA France 74370
    85 Centre Hospitalier Universitaire CHU de Rennes - Hopital de Pontchaillou Rennes FRA France 35033
    86 Institut de cancerologie Strasbourg-Europe Strasbourg FRA France 67033
    87 Institut Gustave Roussy Villejuif Paris France 94805
    88 Universitaetsklinikum Erlangen Erlangen Bavaria Germany 91054
    89 HELIOS Klinikum Berlin-Buch Saarow Berlin DEU Germany 13125
    90 Charite - Universitaetsmedizin Berlin Berlin DEU Germany 13353
    91 Universitaetsklinik Dresden Dresden DEU Germany 1307
    92 University Hospital Essen Essen DEU Germany 45147
    93 Institut fr Klinisch Onkologische ForschungKrankenhaus Nordwest GmbH Frankfurt Am Main DEU Germany 60488
    94 Haematologisch-Onkologische Praxis Hamburg Eppendorf Hamburg DEU Germany 20249
    95 Asklepios Tumorzentrum Hamburg AK Altona Hamburg DEU Germany 22763
    96 Universitaeres Krebszentrum Leipzig Leipzig DEU Germany 4103
    97 RKH Kliniken Ludwigsburg DEU Germany 22763
    98 Universitaetsmedizin Mannheim- III. Medizinische Klinik Mannheim DEU Germany 68167
    99 Klinikum Neuperlach Muenchen DEU Germany 81737
    100 Zentrum für Hämatologie und Onkologie MVZ GmbH Porta Westfalica DEU Germany 32457
    101 Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet, Szent Laszlo Korhaz Budapest HUN Hungary 1097
    102 National Institute of Oncology Budapest HUN Hungary 1122
    103 Magyar Honvedseg Egeszsegugyi Kozpont Budapest HUN Hungary H-1062
    104 Debreceni Egyetem Klinikai Kozpont Debrecen HUN Hungary 4032
    105 Bacs- Kiskun Megyei Korhaz Kecskemét HUN Hungary 6000
    106 Szabolcs-Szatmar-Bereg megyei Korhazak es Egyetemi Oktatokorhaz Nyiregyhaza HUN Hungary 4400
    107 Hetenyi G Korhaz, Onkologiai Kozpont Szolnok HUN Hungary 5004
    108 Szent Borbala Korhaz Tatabanya HUN Hungary 2800
    109 Somogy Megyei Kaposi Mor Oktato Korhaz, Klinikai Onkologiai Osztaly Kaposvár Somogy Hungary 7400
    110 Zala Megyei Szent Rafael Korhaz, Onkologiai Osztaly, F epulet 3. em. Zalaegerszeg Zala Hungary 8900
    111 Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Megyei Onkologiai Kozpont Gyula Hungary 5700
    112 Fondazione Poliambulanza Hospital Brescia ITA Italy 25124
    113 Policlinico San Martino di Genova Genova ITA Italy 16132
    114 Fondazione IRCCS Istituto Nazionale dei Tumori Milano ITA Italy 20133
    115 ASST Grande Ospedale Metropolitano Niguarda Milano ITA Italy 20162
    116 Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Naples ITA Italy 80131
    117 Istituto Oncologico Veneto Irccs Padova ITA Italy 35128
    118 Azienda Ospedaliero Universitaria Pisana Pisa ITA Italy 56126
    119 Azienda USL-IRCCS di Reggio Emilia Reggio Emilia ITA Italy 42123
    120 AO Card G Panico Tricase ITA Italy 73039
    121 Ospedale San Bortolo Azienda ULSS8 Berica - Distretto Est Vicenza ITA Italy 36100
    122 Istituto Clinico Humanitas Rozzano MI Lombardy Italy 20089
    123 Aichi Cancer Center Nagoya Aichi Japan 464-8681
    124 National Cancer Center Hospital East Kashiwa-shi Chiba Japan 277-8577
    125 Shikoku Cancer Center Matsuyama City Ehime Japan 791-0280
    126 Kyushu Cancer Center Fukuoka-shi Fukuoka Japan 811-1395
    127 Hokkaido University Hospital Sapporo-shi Hokkaido Japan 060-8648
    128 St. Marianna University School of Medicine Hospital Kawasaki-shi Kanagawa Japan 216-8511
    129 Kindai University Hospital Osakasayama-shi Osaka Japan 589-8511
    130 Osaka University Hospital Suita-shi Osaka Japan 565-0871
    131 Shizuoka Cancer Center Shizuoka Sunto-gun Japan 411-8777
    132 National Cancer Center Hospital Chuo-ku Tokyo Japan 104-0045
    133 M Sklodowska Curie Memorial Cancer Center, Klinika Gastroenterologii Onkologicznej Warszawa Masovia Poland 02034
    134 Bialostockie Centrum Onkologii im. Marii Skodowskiej-Curie Bialystok Podlaskie Poland 15-027
    135 Hospital Universitari Vall dHebron Barcelona ESP Spain 8035
    136 Hospital Universitario Reina Sofa Córdoba ESP Spain 14004
    137 Hospital General Universitario de Elche Elche ESP Spain 3203
    138 Hospital Universitario Ramón y Cajal Madrid ESP Spain 28034
    139 Hospital Clinico San Carlos Madrid ESP Spain 28040
    140 Hospital Universitario 12 de Octubre Madrid ESP Spain 28041
    141 Hospital Universitario La Paz Madrid ESP Spain 28046
    142 Hospital Universitario HM Sanchinarro Madrid ESP Spain 28050
    143 Hospital Universitario Puerta de Hierro Majadahonda ESP Spain 28222
    144 Hospital Regional Universitario Carlos Haya Malaga ESP Spain 29010
    145 Hospital Universitario Central de Asturias Oviedo ESP Spain 33013
    146 Hospital Universitario Marques de Valdecilla Santander ESP Spain 39008
    147 Hospital ClÃ-nico Universitario de Santiago-CHUS Santiago De Compostela ESP Spain 15706
    148 Hospital General Universitario Gregorio Maranon HGUGM Madrid Spain 28007
    149 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
    150 Hospital Clinico Universitario de Valencia Valencia Spain 46010
    151 Aberdeen Royal Infirmary Aberdeen GBR United Kingdom AB25 2ZN
    152 The Royal Marsden Hospital London GBR United Kingdom SW3 6JJ
    153 Sarah Cannon Research Institute UK London Middlesex United Kingdom W1G 6AD

    Sponsors and Collaborators

    • Hutchison Medipharma Limited

    Investigators

    • Study Director: William Schelman, MD, PhD, Hutchison MediPharma International

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hutchison Medipharma Limited
    ClinicalTrials.gov Identifier:
    NCT04322539
    Other Study ID Numbers:
    • 2019-013-GLOB1
    First Posted:
    Mar 26, 2020
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hutchison Medipharma Limited
    colon
    colorectal
    mcrc
    crc
    metastatic colon
    metastatic colorectal
    VEGF
    VEGFR
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Mar 25, 2022