A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer
CanStem303C
A Phase 3 Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC).
3 other identifiers
interventional
1,253
16 countries
211
Brief Summary
This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Jun 2016
211 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
First Submitted
Initial submission to the registry
April 25, 2016
CompletedFirst Posted
Study publicly available on registry
April 27, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2021
CompletedResults Posted
Study results publicly available
April 26, 2022
CompletedNovember 15, 2023
November 1, 2023
3.9 years
April 25, 2016
October 26, 2021
November 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall survival was defined as the time from randomization until death from any cause. Patients who are alive at the time of the interim or the final analyses or who have become lost to follow-up will be censored on the date the patient was last known to be alive.
Randomization to Date of Death from any cause or database cutoff date (28 Apr 2020) (Approximately 43 months)
Secondary Outcomes (6)
Progression-Free Survival (PFS)
Randomization to Date of Death or until the date of first documented objective disease progression or database cutoff date (28 Apr 2020) (Approximately 43 months)
Disease Control Rate (DCR)
Randomization to Date of Death or until the date of first documented objective disease progression or database cutoff date (28 Apr 2020) (Approximately 43 months)
Objective Response Rate (ORR)
Randomization to Date of Death or until the date of first documented objective disease progression or database cutoff date (28 Apr 2020) (Approximately 43 months)
Mean Change From Baseline for Global Health Status at Time 2 (Cycle 5 Day 1) and Time 4 (Cycle 9 Day 1).
From baseline at Time 2 (Cycle 5 Day 1), approximately 57 days and Time 4 (Cycle 9 Day 1), approximately 113 days
Mean Change From Baseline for Physical Functioning Status at Time 2 (Cycle 5 Day 1) and Time 4 (Cycle 9 Day 1).
From baseline at Time 2 (Cycle 5 Day 1) and Time 4 (Cycle 9 Day 1)
- +1 more secondary outcomes
Study Arms (2)
Napabucasin plus FOLFIRI
EXPERIMENTALAddition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will start at least 2 hours following the first daily dose of napabucasin and will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion in selected patients to receive standard dose of bevacizumab (5 mg/kg). Irinotecan 180 mg/m\^2 together with leucovorin 400 mg/m\^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively, starting on Day 1 of Cycle 1, following bevacizumab infusion or at least 2 hours following the first daily dose of napabucasin if bevacizumab is not administered. 5-FU 400 mg/m\^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m\^2/day (total 2400 mg/m\^2) continuous infusion. This regimen will be repeated on Day 1 of every 14 day cycle.
FOLFIRI
ACTIVE COMPARATORAddition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion in selected patients to receive standard dose of bevacizumab (5 mg/kg). Irinotecan 180 mg/m\^2 together with leucovorin 400 mg/m\^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively, starting on Day 1 of Cycle 1, following bevacizumab infusion. 5-FU 400 mg/m\^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m\^2/day (total 2400 mg/m\^2) continuous infusion. This regimen will be repeated on Day 1 of every 14 day cycle.
Interventions
Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).
Eligibility Criteria
You may qualify if:
- Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable ICH guidelines and local and regulatory requirements prior to the performance of any study specific procedure.
- Must have histologically confirmed advanced CRC that is metastatic.
- Must have failed treatment with one regimen containing a fluoropyrimidine, oxaliplatin with or without bevacizumab for metastatic disease. All patients must have received a minimum of 6 weeks of the first-line regimen that included bevacizumab (if applicable), oxaliplatin and a fluoropyrimidine in the same cycle. Treatment failure is defined as radiologic progression during or \< 6 months after the last dose of first-line therapy.
- FOLFIRI therapy is appropriate for the patient and is recommended by the Investigator.
- Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease performed within 21 days prior to randomization. Patients with either measurable disease or non-measurable evaluable disease are eligible.
- Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Must be ≥ 18 years of age.
- For male or female patient of child bearing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days for female and male patients, of the final FOLFIRI dose. Patients who receive single agent napabucasin without FOLFIRI must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days for female patients and 90 days for male patients, of the final napabucasin dose.
- Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization. The minimum sensitivity of the pregnancy test must be 25 IU/L or equivalent units of HCG.
- Must have alanine transaminase (ALT) ≤ 3 × institutional upper limit of normal (ULN) \[≤ 5 × ULN in presence of liver metastases\] within 14 days prior to randomization.
- Must have hemoglobin (Hgb) ≥ 9.0 g/dL within 14 days prior to randomization. Must not have required transfusion of red blood cells within 1 week of baseline Hgb assessment.
- Must have total bilirubin ≤ 1.5 × institutional ULN \[≤ 2.0 x ULN in presence of liver metastases\] within 14 days prior to randomization.
- Must have creatinine ≤ 1.5 × institutional ULN or Creatinine Clearance \> 50 ml/min (as calculated by the Cockcroft-Gault equation (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) within 14 days prior to randomization.
- Must have absolute neutrophil count ≥ 1.5 x 10\^9/L within 14 days prior to randomization.
- Must have platelet count ≥ 100 x 10\^9/L within 14 days prior to randomization. Must not have required transfusion of platelets within 1 week of baseline platelet assessment.
- +7 more criteria
You may not qualify if:
- Anti-cancer chemotherapy or biologic therapy if administered prior to the first planned dose of study medication (napabucasin or FOLFIRI) within period of time equivalent to the usual cycle length of the regimen. An exception is made for oral fluoropyrimidines (e.g. capecitabine, S-1), where a minimum of 10 days since last dose must be observed prior to the first planned dose of study medication. Standard dose of bevacizumab (5 mg/kg) may be administered prior to FOLFIRI infusion, per Investigator decision, for as long as permanent decision to include or exclude bevacizumab is made prior to patient randomization. Radiotherapy, immunotherapy (including immunotherapy administered for non-malignant diseaseneoplastic treatment purposes), or investigational agents within four weeks of first planned dose of study medication, with the exception of a single dose of radiation up to 8 Gy (equal to 800 RAD) with palliative intent for pain control up to 14 days before randomization.
- More than one prior chemotherapy regimen administered in the metastatic setting.
- Major surgery within 4 weeks prior to randomization.
- Patients with any known brain or leptomeningeal metastases are excluded, even if treated.
- Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for 4 weeks after the last dose of napabucasin or while undergoing treatment with FOLFIRI and for 180 days after the last dose of FOLFIRI.
- Gastrointestinal disorder(s) which, in the opinion of the Qualified/Principal Investigator, would significantly impede the absorption of an oral agent (e.g. intestinal occlusion, active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection).
- Unable or unwilling to swallow napabucasin capsules daily.
- Prior treatment with napabucasin.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
- Known hypersensitivity to 5-fluorouracil/leucovorin
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Known hypersensitivity to irinotecan
- Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Patients receiving treatment with St. John's wort or Phenytoin.
- Patients who plan to receive yellow fever vaccine during the course of the study treatment.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (211)
Alabama Oncology
Birmingham, Alabama, 35223, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85771, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
City of Hope- Comprehensive Care Center
Duarte, California, 91010, United States
University of California-San Diego/Moores UCSD Cancer Center
La Jolla, California, 92093, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, 90017, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UCLA Hematology Oncology Santa Monica
Santa Monica, California, 90404, United States
St. Joseph Heritage Healthcare
Santa Rosa, California, 95405, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
St Mary's Hospital & Regional Med Center
Grand Junction, Colorado, 81501, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, 19713, United States
Florida Cancer Specialists & Research Institute Fort Myers
Fort Myers, Florida, 33901, United States
Memorial Cancer Institute at Memorial Hospital
Hollywood, Florida, 33021, United States
Baptist Health Medical Group Oncology, LLC
Miami, Florida, 33176, United States
Sarah Cannon Research Institution
St. Petersburg, Florida, 33705, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
Piedmont Cancer Institute, PC
Atlanta, Georgia, 30318, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Suburban Hematology-Oncology Associates, PC - Lawrenceville
Lawrenceville, Georgia, 30046, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
Northshore University Healthsystem
Evanston, Illinois, 60201, United States
Healthcare Research Network III, LLC
Tinley Park, Illinois, 60487, United States
Northwestern Medicine Cancer Center
Warrenville, Illinois, 60555, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Michiana Hematology Oncology, PC
Mishawaka, Indiana, 46545, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Dana Farber
Boston, Massachusetts, 02215, United States
Umass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of Michigan Cancer Center
Ann Arbor, Michigan, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
Mayo Clinic Arizona
Rochester, Minnesota, 55905, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Missouri Baptist Medical Center ACCRU Network Site
St Louis, Missouri, 63131, United States
Saint Francis Cancer Treatment Center
Grand Island, Nebraska, 68803, United States
Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Cancer Research Network of Nebraska / Oncology Associates PC
Omaha, Nebraska, 68118, United States
Tennessee Oncology PLLC
Omaha, Nebraska, 68118, United States
Darthmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Carol G. Simon Cancer Center
Morristown, New Jersey, 07962, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Roswell Park Cancer Center
Buffalo, New York, 14263, United States
North Shore Hematology Oncology Associates
East Setauket, New York, 11733, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Toledo Clinic Cancer Centers
Toledo, Ohio, 43623, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
Medical University of South Carolina
Charleston, South Carolina, 29412, United States
Sanford Cancer Center
Sioux Falls, South Dakota, 57104, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
West Cancer Center
Memphis, Tennessee, 38138, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Texas Oncology-Austin Midtown
Austin, Texas, 75705, United States
Texas Oncology - Dallas Center
Dallas, Texas, 75203, United States
Texas Oncology - Denton South
Denton, Texas, 76210, United States
Texas Oncology - Fort Worth
Fort Worth, Texas, 76104, United States
Millenium Oncology
Houston, Texas, 77090, United States
Texas Health Physicians Group
Plano, Texas, 75093, United States
Texas Oncology-San Antonio
San Antonio, Texas, 78217, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Texas Oncology - Wichita Falls Texoma Cancer Center
Wichita Falls, Texas, 76310, United States
Northern Utah Associates
Ogden, Utah, 84403, United States
US Oncology - Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060, United States
Virginia Oncology Associates
Hampton, Virginia, 23666, United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Virginia Mason
Seattle, Washington, 98101, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684, United States
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, 2200, Australia
St Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
St Vincent's hospital Melbourne
Fitzroy, New South Wales, 3065, Australia
Port Macquaries Base Hospital
Port Macquarie, New South Wales, 2444, Australia
Northern Cancer Institute
St Leonards, New South Wales, 2065, Australia
Sunshine Coast Hospital and Health Service
Nambour, Queensland, 4560, Australia
Gold Coast University Hosptial
Southport, Queensland, 4215, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, 5011, Australia
Bendigo Hospital
Bendigo, Victoria, 3550, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Western Health
Melbourne, Victoria, 3021, Australia
Goulburn Valley Health
Shepparton, Victoria, 3630, Australia
Prince of Wales Hospital
Randwick, 2031, Australia
Imelda Ziekenhuis
Bonheiden, Antwerpen, 2820, Belgium
Imelda Ziekenhuis
Bonheiden, Antwerpen, 2821, Belgium
Imelda Ziekenhuis
Bonheiden, Antwerpen, 2822, Belgium
AZ Turnhout - Campus Sint-Elisabeth
Turnhout, Antwerpen, 2300, Belgium
Hôpital Erasme
Brussels, Brussels Capital, 1070, Belgium
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi, Hainaut, 6000, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Brussels, Liège, 1050, Belgium
UZ Leuven - Campus Gasthuisberg
Leuven, Vlaams Brabant, 3000, Belgium
AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan
Bruges, West-Vlaanderen, 8000, Belgium
AZ Sint-Lucas - Campus Sint-Lucas
Bruges, West-Vlaanderen, 8310, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
University of Toronto - Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Saint Michael's Hospital Li Ka Shing Knowledge Institute
Toronto, Ontario, M5B 1W8, Canada
St. Mary's Hospital Center
Montreal, Quebec, H3T 1M5, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, HZL 4M1, Canada
Beijing Cancer Hospital
Beijing, 100142, China
Henan Cancer Hospital
Henan, 450008, China
Jiangsu Province Hospital
Jiangsu, 210029, China
FN Hradec Kralove
Hradec Králové, Královéhradecký kraj, 500 05, Czechia
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Masarykuv onkologicky ustav
Brno, 656 53, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Centre Paul Papin
Angers, 49055, France
Hospitalier Jean Minjoz
Besançon, 25030, France
Hôpital Morvan - CHRU de Brest - cancérologie et d'hématolog
Brest, 29609, France
CHU Estaing
Clermont-Ferrand, 63003, France
Centre de Lutte Contre le Cancer (CLCC)
Dijon, 21079, France
CHU de Nantes - Hopital Hotel Dieu
Nantes, 44093, France
Hôpital Européen Georges Pompidou - Digestive Oncology
Paris, 75015, France
Hôpital Privé des Côtes d'Armor - Service oncologie
Plérin, 22190, France
Hospital of Poitiers
Poitiers, 86021, France
Centre Eugene Marquis
Rennes, 35042, France
Centre Rene Gauducheau
Saint-Herblain, 44805, France
Leopoldina Krankenhaus Med. Klinik 2
Schweinfurt, Bavaria, 97422, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, 01307, Germany
Schwerpunkpraxis für Hämatologie und Onkologie
Magdeburg, Saxony-Anhalt, 39104, Germany
Gesundheitszentrum Wetterau
Bad Nauheim, 61231, Germany
Vivantes Klinikum Am Urban
Berlin, 10967, Germany
Charite - Campus Benjamin Franklin (Cbf)
Berlin, 12203, Germany
DRK Kliniken Berlin Koepenick
Berlin, 12559, Germany
Charité Universitätsmedizin
Berlin, 13353, Germany
MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin, 14195, Germany
Facharztzentrum Eppendorf
Hamburg, 20249, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Universitätsklinikum Marburg
Marburg, 35033, Germany
Medizinische Universitaetsklin
Ulm, 89081, Germany
Pamela Youde Nethersole Eastern Hospital
Hong Kong, 150001, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Ha'Emek Medical Center
Afula, 1834111, Israel
The Barzilai Medical Center - Oncology Institute
Ashkelon, 7830604, Israel
Soroka University Medical Center
Beersheba, 8410101, Israel
Shaare Zedek Medical center
Jerusalem, 91031, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin MC - Oncology, Davidoff Center
Petah Tikva, 49100, Israel
Ziv Medical Center (The Rebecca Sieff Hospital)
Safed, 13100, Israel
Tel Aviv Sourasky Medical Center - Oncology
Tel Aviv, 6423906, Israel
The Chaim Sheba Medical Centre - Division of Oncology
Tel Litwinsky, 52621, Israel
AOU Ospedali Riuniti Umberto I - GM.Lanc
Torrette Di Ancona, Ancona, 60126, Italy
Ospedale Santa Maria del Prato
Feltre, Belluno, 32032, Italy
Irccs Irst
Meldola, Forli, 47014, Italy
AUSL della Romagna, Osp. degli Infermi
Faenza, Ravenna, 48018, Italy
Policlinico S.Orsola Malpighi, AOU di Bologna
Bologna, 40138, Italy
PO di Cremona, ASST di Cremona
Cremona, 26100, Italy
AO S. Martino, IRCCS, IST
Genova, 16132, Italy
Ieo, Irccs
Milan, 20141, Italy
AOU Policlinico di Modena
Modena, 41124, Italy
Università degli studi della Campania "L.Vanvitelli"
Napoli, 80131, Italy
Ospedale Guglielmo da Saliceto, AUSL Piacenza
Piacenza, 29121, Italy
AOU Città della Salute e della Scienza di Torino - Molinette
Torino, 10126, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsunami, Ehime, 791-0280, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
ST. Marianna University School of Medicine
Kawasaki, Kanagawa, 216-8511, Japan
Osaka University Hospital
Suita, Osaka, 565-0871, Japan
Osaka Medical College Hospital
Takatsuki, Osaka, 569-8686, Japan
Saitama Cancer Center
Kita-Adachi, Saitama, 362-0806, Japan
Shizuoka Cancer Center
Sunto, Shizuoka, 411-8777, Japan
Medical Hospital, Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, 113-8510, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
The cancer insitute hospital of JFCR (Japanese Foundation For Cancer Research)
Koto-ku, Tokyo, 135-8550, Japan
National Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, 537-8511, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540-0006, Japan
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD, Netherlands
Academisch Medisch Centrum
Amsterdam, 1055 AZ, Netherlands
Spaarne Gasthuis
Hoofddorp, 2134 TM, Netherlands
Maastricht UMC
Maastricht, 6229 HX, Netherlands
Elizabeth Tweesteden Ziekenhuis locatie Tilburg
Tilburg, 5042 SB, Netherlands
National University Cancer Institute
Singapore, Central Singapore, 119228, Singapore
National Cancer Centre
Singapore, Central Singapore, 169610, Singapore
Raffles Hospital
Singapore, Central Singapore, 188770, Singapore
Yeungnam University Medical Center
Daegu, Daegu Gwang'yeogsi, 42415, South Korea
National Cancer Centre
Goyang, Gyeonggido, 10408, South Korea
Ajou University Hospital
Suwon, Gyeonggido, 16499, South Korea
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi, 21565, South Korea
Korea University Anam Hospital
Seoul, Seoul Teugbyeolsi, 02841, South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Korea University Guro Hospital
Seoul, Seoul Teugbyeolsi, 08308, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 120-752, South Korea
Hospital General Universitario de Elche
Elche, Alicante, 3203, Spain
H.U.V. del Rocío
Seville, Andalusia, 41013, Spain
Hospital Son Llatzer
Baleares, Balearic Islands, 7198, Spain
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 8916, Spain
Complexo Hospital Universitario A Coruña
A Coruña, Galicia, 15006, Spain
Hospital Universitario Fundacion Alcorcon (HUFA)
Alcorcón, Madrid, 28922, Spain
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Consorci Hospital General Universitari Valencia (CHGUV)
Comunidad Valenciana, Valencia, 46014, Spain
Hospital Universitario Vall d'Hebrón
Barcelona, 080035, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, 8036, Spain
Hospital Universitario Gregorio Marañón
Madrid, 28016, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, 30120, Spain
Hospital Universitario Virgen de la Macarena
Seville, 41009, Spain
H.C.U.Valencia
Valencia, 46010, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Keiichi Saito
- Organization
- Sumitomo Dainippon Pharma Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
April 25, 2016
First Posted
April 27, 2016
Study Start
June 1, 2016
Primary Completion
April 28, 2020
Study Completion
May 12, 2021
Last Updated
November 15, 2023
Results First Posted
April 26, 2022
Record last verified: 2023-11