A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
CanStem111P
A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
1 other identifier
interventional
1,134
19 countries
262
Brief Summary
This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult patients with Metastatic Pancreatic Ductal Adenocarcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2016
Typical duration for phase_3
262 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 13, 2016
CompletedFirst Posted
Study publicly available on registry
December 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedResults Posted
Study results publicly available
June 10, 2021
CompletedNovember 15, 2023
November 1, 2023
3.2 years
December 13, 2016
March 29, 2021
November 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma.
From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.
Secondary Outcomes (5)
Progression Free Survival
From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
Disease Control Rate
From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
Overall Response Rate
From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
Number of Patients With Adverse Events
Every 1-2 weeks from date of screening until protocol treatment discontinuation. Following permanent protocol treatment discontinuation, every 8 weeks, starting with the 4 week post-protocol treatment discontinuation visit, up to 36 months.
Mean Change From Baseline for Global Quality of Life (QoL) at 8 Weeks.
8 weeks
Other Outcomes (4)
Overall Survival in Biomarker Positive Patients
From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.
Progression Free Survival in Biomarker Positive Patients
From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
Disease Control Rate in Biomarker Positive Patients
From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
- +1 more other outcomes
Study Arms (2)
Arm 1: Napabucasin plus Nab-paclitaxel with Gemcitabine
EXPERIMENTALPatients randomized to this arm will receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
Arm 2: Nab-paclitaxel with Gemcitabine
ACTIVE COMPARATORPatients randomized to this arm will receive weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
Interventions
Napabucasin will be administered orally, twice daily, with doses separated by approximately 12 hours.
Nab-paclitaxel 125 mg/m\^2 immediately followed by gemcitabine 1000 mg/m\^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.
Nab-paclitaxel 125 mg/m\^2 immediately followed by gemcitabine 1000 mg/m\^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.
Eligibility Criteria
You may qualify if:
- Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable International Conference on Harmonization (ICH) guidelines and local and regulatory requirements prior to the performance of any study specific procedure.
- Must have histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma (PDAC) that is metastatic. The definitive diagnosis of metastatic PDAC will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.
- Must not have previously received chemotherapy or any investigational agent for the treatment of PDAC. A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed for as long as last dose was administered \> 6 months prior to randomization and no lingering toxicities are present.
- Nab-paclitaxel with gemcitabine therapy is appropriate for the patient and recommended by the Investigator.
- Patient has one or more metastatic tumors evaluable by CT scan with contrast (or MRI, if patient is allergic to CT contrast media) per RECIST 1.1. Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease must be performed within 14 days prior to randomization. Qualifying scans performed as part of standard of care prior to patient signature of the study informed consent will be acceptable as baseline scanning as long as scanning is performed \< 14 days prior to randomization.
- Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, assessed within 14 days prior to randomization. Two observers qualified to perform assessment of the performance status will be required to perform this assessment. If discrepant, the one with the most deteriorated performance status will be considered true.
- Must have life-expectancy of \> 12 weeks.
You may not qualify if:
- For male or female patients of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days after the final dose of nab-paclitaxel and gemcitabine or for 30 days for female patients and for 90 days for male patients, after the final napabucasin dose if nab-paclitaxel and gemcitabine were not administered.
- Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization.
- Patient has adequate biological parameters as demonstrated by the following blood counts at baseline (obtained \< 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed \< 14 days prior to randomization):
- Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
- Platelet count \> 100,000/mm\^3 (100 x 10\^9/L). Must not have required transfusion of platelets within 1 week of baseline platelet count assessment.
- Hemoglobin (HgB) \> 9 g/dL. Must not have required transfusion of red blood cells within 1 week of baseline Hgb assessment.
- Patient has the following blood chemistry levels at baseline (obtained \< 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed \< 14 days prior to randomization):
- AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional upper limit of normal (ULN) \[≤ 5 × ULN in presence of liver metastases\]
- Total bilirubin ≤ 1.5 x institutional ULN. If total bilirubin is \> ULN and \< 1.5 x ULN, it must be non-rising for at least 7 days.
- Serum creatinine within normal limits or calculated clearance \> 60 mL/min/1.73 m\^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg. Using the Cockcroft-Gault formula). For patients with a Body Mass Index (BMI) \> 30 kg/m\^2, lean body weight should be used instead.
- Patient not on anticoagulation has acceptable coagulation studies (obtained \< 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed \< 14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) below or within normal limits (+15%).
- Patients on anticoagulation must have coagulation values within the therapeutic range appropriate for the anti-coagulation indication.
- Patient has no clinically significant abnormalities on urinalysis results (obtained \< 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed \< 14 days prior to randomization).
- Patient must have adequate nutritional status with Body Mass Index (BMI) \> 18 kg/m\^2 and body weight of \> 40 kg with serum albumin \> 3 g/dL.
- Baseline laboratory evaluations must be done within 14 days prior to randomization and some must be repeated \< 72 hours prior to randomization.
- +42 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (267)
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
Clearview Cancer Institute (CCI)
Huntsville, Alabama, 35805, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, 90017, United States
University of Southern California
Los Angeles, California, 90033, United States
St. Joseph Hospital of Orange
Orange, California, 92868, United States
Torrance Health Association DBA Torrance Memorial
Redondo Beach, California, 90277, United States
UC Davis
Sacramento, California, 95817, United States
UCLA Medical Center Santa Monica Hematology And Oncology
Santa Monica, California, 90404-2125, United States
Kaiser Permanente - Vallejo Medical Center
Vallejo, California, 94589-2441, United States
Norwalk Hospital The C Anthony and Jean Whittingham Cancer Center
Norwalk, Connecticut, 06850-3852, United States
The C Anthony and Jean Whittingham Cancer Center
Norwalk, Connecticut, 06850-3852, United States
Helen F. Graham Cancer Center
Newark, Delaware, 19713, United States
Georgetown University Medical Center (GUMC)
Washington D.C., District of Columbia, 20007, United States
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, 33916, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Mayo Clinic Cancer Center
Jacksonville, Florida, 32224, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
UF Health Cancer Center - Orlando Health
Orlando, Florida, 32806, United States
Florida Cancer Specialists North
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists East Region
Wellington, Florida, 33414, United States
University Cancer & Blood Center
Athens, Georgia, 30607, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Saint Alphonsus Health System
Boise, Idaho, 83706, United States
NorthShore University Health Systems
Evanston, Illinois, 60201, United States
Ingalls Cancer Research Center
Harvey, Illinois, 60426, United States
Carle Cancer Center CCOP
Urbana, Illinois, 61801, United States
Northwestern Medicine Regional Medical Group
Warrenville, Illinois, 60555-3269, United States
Parkview Physician Group (PPG)
Fort Wayne, Indiana, 46845, United States
Indiana University - Melvin and Bren Simon Cancer
Indianapolis, Indiana, 46202, United States
Cotton O'Neil Cancer Center
Topeka, Kansas, 66606, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Louisiana Hematology Oncology Associates (LHOA)
Baton Rouge, Louisiana, 70809, United States
Maine Center for Cancer Medicine - Scarborough
Scarborough, Maine, 04074-7171, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48334, United States
St. Luke's Hospital of Duluth
Duluth, Minnesota, 55805, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Metro MN Clinical Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Jackson Oncology Associates
Jackson, Mississippi, 39202, United States
University of Missouri - Ellis Fischel Cancer Cent
Columbia, Missouri, 65212, United States
Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
HCA Midwest Division (Kansas City)
Kansas City, Missouri, 64132, United States
Mercy Clinic - Cancer & Hematology
Springfield, Missouri, 65804, United States
Washington University School of Medicine
St Louis, Missouri, 63110-1032, United States
St. Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
UNM Cancer Research and Treatment Center
Albuquerque, New Mexico, 87131, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
Basset Medical Center
Cooperstown, New York, 13326, United States
North Shore Hematology Oncology Associates PC
East Setauket, New York, 11733, United States
Hematology Oncology Associates of Central New York
East Syracuse, New York, 13057, United States
Clinical Research Alliance
Lake Success, New York, 11042, United States
Weill Cornell Medicine/ NewYork-Presbyterian
New York, New York, 10021, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Stony Brook University
Stony Brook, New York, 11794, United States
Montefiore Cancer Center
The Bronx, New York, 10467, United States
UNC Chapel Hill / Lineberger Comprehensive Cancer
Chapel Hill, North Carolina, 27599, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374, United States
Wake Forest Baptist Hospital
Winston-Salem, North Carolina, 27157, United States
Gabrail Cancer Center (GCC) - Canton Facility
Canton, Ohio, 44718, United States
Toledo Clinic Cancer Centers
Toledo, Ohio, 43623-3536, United States
Cancer Center of Southwest Oklahoma
Lawton, Oklahoma, 73505, United States
Mercy Clinic Oncology and Hematology - McAuley
Oklahoma City, Oklahoma, 73120, United States
Kaiser Permanente - Westside Medical Office
Hillsboro, Oregon, 97124-5806, United States
OHSU Knight Cancer Institute
Portland, Oregon, 97120, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Fox Chase Cancer Center (FCCC) - Philadelphia
Philadelphia, Pennsylvania, 19111-2434, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, 29414, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425-8900, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607-5253, United States
GHS Cancer Institute
Greenville, South Carolina, 29615, United States
Avera Medical Group
Sioux Falls, South Dakota, 57105, United States
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
SCRI - Tennessee Oncology
Nashville, Tennessee, 37203-1625, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Bon Secours Cancer Institute Medical Oncology
Midlothian, Virginia, 23114-3203, United States
Virginia Cancer Institute
Richmond, Virginia, 23226, United States
Oncology and Hematology Associates of Southwest Virginia
Roanoke, Virginia, 24014, United States
The Everett Clinic
Everett, Washington, 98201, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, 98405, United States
West Virginia University Mary Babb Randolph Cancer Center (MBRCC)
Morgantown, West Virginia, 26506, United States
HSHS St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology, Ltd. - West Green Bay
Green Bay, Wisconsin, 54303, United States
Aurora St. Luke's Medical Center - Vince Lombardi
Milwaukee, Wisconsin, 53215-4330, United States
Border Medical Oncology
East Albury, New South Wales, 2109, Australia
Macquarie University Hospital
Sydney, New South Wales, 2109, Australia
ICON Cancer Care
South Brisbane, South Australia, 4101, Australia
Cabrini Hospital
Malvern, Victoria, 3144, Australia
Blacktown Cancer and Haematology Centre
Blacktown, 2148, Australia
Border Medical Oncology
East Albury, 2640, Australia
The Austin Hospital
Heidelberg, 3084, Australia
Cabrini Hospital
Malvern, 3144, Australia
Sir Charles Gairdner Hospital
Nedlands, 6009, Australia
Prince of Wales Private Hospital
Randwick, 2031, Australia
ICON Cancer Care
South Brisbane, 4101, Australia
Macquarie University Hospital
Sydney, 2109, Australia
The Tweed Hospital
Tweed Heads, 2485, Australia
Sydney Adventist Hospital
Wahroonga, 2076, Australia
LKH Universitätsklinikum Graz
Graz, 8036, Austria
Landeskrankenhaus Medical University Innsbruck
Innsbruck, 6020, Austria
Landeskrankenhaus Feldkirch
Rankweil, 6830, Austria
Universitatsklinik far Innere Medizin III
Salzburg, 5020, Austria
Medical University Vienna
Vienna, 1090, Austria
ULB Erasme
Brussels, 13-1070, Belgium
Antwerp University Hospital
Edegem, B-2650, Belgium
UZ Ghent
Ghent, 9000, Belgium
UZ Brussel
Jette, 1070, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU de Liege
Liège, 4000, Belgium
CHU Dinant Godinne
Yvoir, 5530, Belgium
Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick, E3B 5N5, Canada
The Atlantic Clinical Cancer Research Unit (ACCRU)
Halifax, Nova Scotia, B3H 1C2, Canada
Centre Hospitalier de St. Mary
Pointe-Claire, Quebec, H9R 2Y2, Canada
Ciusssmcq
Trois-Rivières, Quebec, G8Z 3R9, Canada
Cross Cancer Institute
Edmonton, T6G 1Z2, Canada
University of Toronto - St. Michael's Hospital
Toronto, M5B 1W8, Canada
Beijing Cancer Hospital
Beijing, 100142, China
Chinese PLA General Hospital
Beijing, 100853, China
Jilin Cancer Hospital
Changchun, 130021, China
The first hospital of jilin university
Changchun, 130021, China
Fujian Medical University Union Hospital
Fuzhou, 350001, China
Cancer Center of Guangzhou Medical University
Guangzhou, 510095, China
Guangdong General Hospital
Guangzhou, 510180, China
The First Affiliated Hospital Zhejiang University
Hangzhou, 310003, China
The Second Affiliated Hospital Zhejiang University
Hangzhou, 310009, China
Sir Run Shaw Hospital School of Medicine Zhejiang University
Hangzhou, 310016, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Harbin Medical University Cancer Hospital
Harbin, 150000, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, 230601, China
The 81 Hospital of the Chinese Peoples Liberation Army
Nanjing, 210002, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
The Affiliated Hospital of Qingdao University
Qingdao, 266061, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Huashan Hospital
Shanghai, 200040, China
Ren Ji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200120, China
East Hospital of Tongji University
Shanghai, 200123, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060, China
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, 710061, China
General Hospital of Ningxia Medical University
Yinchuan, 750004, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Onkologicke oddeleni
Benešov, 25601, Czechia
Fakultni nemocnice Brno Interni hematoonkologicka klinika
Brno, 62500, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 50005, Czechia
University Hospital Olomouc
Olomouc, 77906, Czechia
Onkologické oddělení
Zlín, 762 75, Czechia
Hôpital Sud - CHU Amiens Picardie
Amiens, 80054, France
Hôpital Trousseau, CHRU de Tours
Chambray-lès-Tours, 37170, France
Hopital Edourard Herriot
Lyon, 69437, France
CHU-Hôtel Dieu
Nantes, 44093, France
Centre Antoine Lacassagne
Nice, 06100, France
Hopital Europeen Georges Pompidou
Paris, 75015, France
Poitiers University Hospital
Poitiers, 86021, France
Centre Eugene Marquis
Rennes, 35042, France
Clinique Saint Anne
Strasbourg, 67000, France
Hopital Civil de strasbourg
Strasbourg, 67091, France
Institute de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Gesundheitszentrum St. Marien GmbH
Amberg, 92224, Germany
University Hospital Bonn
Bonn, 53127, Germany
Klinikum Chemnitz
Chemnitz, 09116, Germany
Krankenhaus Nordwest
Frankfurt am Main, 60488, Germany
Medizinische Hochschule
Hanover, 30625, Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, 74078, Germany
Universitätsmedizin Mannheim
Mannheim, 68167, Germany
Klinikum Bogenhausen
München, 81925, Germany
Klinikum Oldenburg AöR - UK für Innere Medizin
Oldenburg, 26133, Germany
Fondazione Poliambulanza
Brescia, 25124, Italy
Istituto Ricerca e la Cura del Cancro (IRCC)
Candiolo, 10060, Italy
AOU Mater Domini
Catanzaro, 88200, Italy
Ospedale degli Infermi
Faenza, 48018, Italy
Santa Maria de Prato Hospital
Feltre, 32032, Italy
IRCCS - Studio e la Cura dei Tumori
Meldola, 47014, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
AO SM Misericordia
Perugia, 06132, Italy
IRCCS Azienda Ospedaliera S.Maria Nuova
Reggio Emilia, 42123, Italy
Ospedale degli Infermi
Rimini, 47923, Italy
Dermatological Hospital San Lazzaro
Torino, 10126, Italy
ASST Settelaghi
Varese, 21100, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681, Japan
Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, 320-0834, Japan
University of Tokyo Hospital
Bunkyō-Ku, Tokyo, 113-8655, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital Of JFCR
Koto-Ku, Tokyo, 135-8550, Japan
Kyorin University Hopsital
Mitaka, Tokyo, 181-8611, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Saitama Cancer Center
Saitama, 362-0806, Japan
Shizuoka Cancer Center
Shizuoka, 411-8777, Japan
Medisch Centrum Leeuwarden (MCL)
Leeuwarden, 8934 AD, Netherlands
Zuyderland Medical Center
Sittard, 6162 BG, Netherlands
University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
Isala Ziekenhuis
Zwolle, 8025 AB, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Centrum Onkologii-Instytut im.M.Sklodowskiej-Curie
Gliwice, 44-101, Poland
Przychodnia Lekarska KOMED
Konin, 62-500, Poland
Klinika Chirurgii Onkologicznej
Lublin, 20-081, Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin, 20-090, Poland
Samodzielny Publiczny Szpital Kliniczny
Poznan, 44-400, Poland
Wojewodzki Szpital Zespolony
Torun, 87-100, Poland
Fundação Champalimaud
Lisbon, 1400-038, Portugal
Hospital da Luz
Lisbon, 1500-650, Portugal
Centro Hospitalar Lisboa Norte
Lisbon, 1649-035, Portugal
Centro Hospitalar do Porto, E.P.E
Porto, 4099-001, Portugal
IPO Porto Francisco Gentil, E.P.E.
Porto, 4200-072, Portugal
Centro Hospitalar Entre Douro e Vouga
Santa Maria da Feira, 4520-211, Portugal
Kursk Regional Clinical Oncology Dispensary
Kislino, Kursk Oblast, 305524, Russia
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, 163046, Russia
Republican Clinical Oncology Dispensary
Cheboksary, 428020, Russia
Llc Evimed
Chelyabinsk, 454087, Russia
Railway Clinical Hospital on station Chelyabinsk
Chelyabinsk, 454091, Russia
Republic Clinical Oncology Dispensary
Kazan', 420029, Russia
N.N. Blokhin Russian Cancer Research Center
Moscow, 115478, Russia
Privolzhsk District Medical Center
Nizhny Novgorod, 603006, Russia
Budgetary Healthcare Institution of Omsk Region
Omsk, 644013, Russia
Orenburg Regional Clinical Oncology Dispensary
Orenburg, 460021, Russia
Pyatigorsk Oncology Dispensary
Pyatigorsk, 357502, Russia
St.Petersburg Medical Universitet n.a. I.P. Pavlov
Saint Petersburg, 197022, Russia
FSBI "Russian Research Centre of Radiology and Surgical Technologies"
Saint Petersburg, 197758, Russia
City Clinical Oncology Dispensary
Saint Petersburg, 198255, Russia
Multi-type clinic 'REAVIZ'
Samara, 443011, Russia
National Research Mordovia State University
Saransk, 430032, Russia
National Cancer Centre Singapore
Singapore, 169610, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Seoul national University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Chonnam National University Hwasun Hospital
Jeongnam, 58128, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Hospital Vall d´Hebron
Barcelona, 08035, Spain
Hospital Clínico y Provincial de Barcelona
Barcelona, 08036, Spain
(ICO) Hospital Duran i Reynals
Barcelona, 08916, Spain
Hospital Universitario Germans Trias i Pujol
Barcelona, 08916, Spain
Hospital Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Centro Integral Oncologico Clara Campal
Madrid, 28050, Spain
Hospital Universitario Puerta de Hierro
Madrid, 28220, Spain
Hospital Universitario Fundacion Alcorcon
Madrid, 28922, Spain
Hospital Regional Universitario de Málaga
Málaga, 29010, Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
LinKou Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Zaytsev Institute General and Urgent Surgery of National Academy Medical Science of Ukraine
Kharkiv, 61005, Ukraine
National Institute of Cancer
Kyiv, 03022, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cindy Oh
- Organization
- Sumitomo Dainippon Pharma Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2016
First Posted
December 15, 2016
Study Start
December 1, 2016
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
November 15, 2023
Results First Posted
June 10, 2021
Record last verified: 2023-11