AzTrials
AzTrials

Colorectal CancerPhase 3CanStem303CNCT02753127

A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer

A Phase 3 study testing Napabucasin, Fluorouracil and Leucovorin in people with Colorectal Cancer, run by Sumitomo Pharma America, Inc. at 211 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Napabucasin, Fluorouracil and Leucovorin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,253 participants
Where
211 sitesin 16 countries
Study dates
Jun 2016to 12 May 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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.
  • Other baseline laboratory evaluations, listed in Section 6.0, must be done within 14 days prior to randomization.
  • Patient must consent to provision of, and Investigator(s) must confirm access to and agree to submit a representative formalin fixed paraffin block of tumor tissue in order that the specific biomarker assays may be conducted. Submission of the tissue is to occur prior to randomization, unless approved by the Sponsor. Where local center regulations prohibit submission of blocks of tumor tissue, two 2 mm cores of tumor from the block and 10-30 unstained slides of whole sections of representative tumor tissue are preferred. Where two 2 mm cores of tumor from the block are unavailable, 10-30 unstained slides of whole sections of representative tumor tissue alone are acceptable. Where no previously resected or biopsied tumor tissue exists or is available, on the approval of the Sponsor/designated CRO, the patient may still be considered eligible for the study.
  • Patient must consent to provision of a sample of blood in order that the specific correlative marker assays may be conducted.
  • Patients must be accessible for treatment and follow-up. Patients registered on this trial must receive protocol treatment and be followed at the participating center. This implies there must be reasonable geographical limits placed on patients being considered for this trial. Investigators must ensure that the patients randomized on this trial will be available for complete documentation of the treatment, response assessment, adverse events, and follow-up.
  • Protocol treatment is to begin within 2 calendar days of patient randomization.
  • The patient is not receiving therapy in a concurrent clinical study and the patient agrees not to participate in other interventional clinical studies during their participation in this trial while on study treatment. Patients participating in surveys or observational studies are eligible to participate in this study.

Who cannot join

  • 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).
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  • 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.
  • Abnormal glucuronidation of bilirubin, known Gilbert's syndrome
  • Patients with QTc interval > 470 milliseconds
  • For patients to be treated with a regimen containing bevacizumab:
  • History of cardiac disease: congestive heart failure (CHF) > New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
  • Current uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management) as well as prior history of hypertensive crisis or hypertensive encephalopathy.
  • History of arterial thrombotic or embolic events (within 6 months prior to study entry)
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection, symptomatic peripheral vascular disease)
  • Evidence of bleeding diathesis or clinically significant coagulopathy
  • Major surgical procedure (including open biopsy, significant traumatic injury, etc.) within 28 days, or anticipation of the need for major surgical procedure during the course of the study as well as minor surgical procedure (excluding placement of a vascular access device or bone marrow biopsy) within 7 days prior to study enrollment
  • Proteinuria at screening as demonstrated by urinalysis with proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
  • History of abdominal fistula, gastrointestinal perforation, peptic ulcer, or intra-abdominal abscess within 6 months
  • Ongoing serious, non-healing wound, ulcer, or bone fracture
  • Known hypersensitivity to any component of bevacizumab
  • History of reversible posterior leukoencephalopathy syndrome (RPLS)
  • History of hypersensitivity to Chinese hamster ovary (CHO) cells or other human or humanized recombinant antibodies.
  • Patients with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 3 years.
  • Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
  • Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.

Trial locations and contacts

211 sites in 16 countries.

211 sites in 16 countries

United States74 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • University of Michigan Cancer Center

    Ann Arbor, Michigan

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • Piedmont Cancer Institute, PC

    Atlanta, Georgia, 30318

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Texas Oncology-Austin Midtown

    Austin, Texas, 75705

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Alabama Oncology

    Birmingham, Alabama, 35223

  • Dana Farber

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Center

    Buffalo, New York, 14263

  • Medical University of South Carolina

    Charleston, South Carolina, 29412

  • Texas Oncology - Dallas Center

    Dallas, Texas, 75203

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Texas Oncology - Denton South

    Denton, Texas, 76210

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • City of Hope- Comprehensive Care Center

    Duarte, California, 91010

  • North Shore Hematology Oncology Associates

    East Setauket, New York, 11733

  • Northshore University Healthsystem

    Evanston, Illinois, 60201

  • US Oncology - Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Fort Belvoir Community Hospital

    Fort Belvoir, Virginia, 22060

  • Florida Cancer Specialists & Research Institute Fort Myers

    Fort Myers, Florida, 33901

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

  • Texas Oncology - Fort Worth

    Fort Worth, Texas, 76104

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Indiana University Health Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Saint Francis Cancer Treatment Center

    Grand Island, Nebraska, 68803

  • St Mary's Hospital & Regional Med Center

    Grand Junction, Colorado, 81501

  • Virginia Oncology Associates

    Hampton, Virginia, 23666

  • Memorial Cancer Institute at Memorial Hospital

    Hollywood, Florida, 33021

  • Millenium Oncology

    Houston, Texas, 77090

  • Research Medical Center

    Kansas City, Missouri, 64132

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • University of California-San Diego/Moores UCSD Cancer Center

    La Jolla, California, 92093

  • Suburban Hematology-Oncology Associates, PC - Lawrenceville

    Lawrenceville, Georgia, 30046

  • Darthmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90017

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • West Cancer Center

    Memphis, Tennessee, 38138

  • Baptist Health Medical Group Oncology, LLC

    Miami, Florida, 33176

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Michiana Hematology Oncology, PC

    Mishawaka, Indiana, 46545

  • Carol G. Simon Cancer Center

    Morristown, New Jersey, 07962

  • The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Weill Cornell Medical College

    New York, New York, 10065

  • Medical Oncology Hematology Consultants, PA

    Newark, Delaware, 19713

  • Northern Utah Associates

    Ogden, Utah, 84403

  • Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Cancer Research Network of Nebraska / Oncology Associates PC

    Omaha, Nebraska, 68118

  • Tennessee Oncology PLLC

    Omaha, Nebraska, 68118

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • VA Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • Texas Health Physicians Group

    Plano, Texas, 75093

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Mayo Clinic Arizona

    Rochester, Minnesota, 55905

  • Texas Oncology-San Antonio

    San Antonio, Texas, 78217

  • UCLA Hematology Oncology Santa Monica

    Santa Monica, California, 90404

  • St. Joseph Heritage Healthcare

    Santa Rosa, California, 95405

  • Virginia Mason

    Seattle, Washington, 98101

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109-1023

  • Sanford Cancer Center

    Sioux Falls, South Dakota, 57104

  • Missouri Baptist Medical Center ACCRU Network Site

    St Louis, Missouri, 63131

  • Sarah Cannon Research Institution

    St. Petersburg, Florida, 33705

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Healthcare Research Network III, LLC

    Tinley Park, Illinois, 60487

  • Toledo Clinic Cancer Centers

    Toledo, Ohio, 43623

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85771

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98684

  • Northwestern Medicine Cancer Center

    Warrenville, Illinois, 60555

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Texas Oncology - Wichita Falls Texoma Cancer Center

    Wichita Falls, Texas, 76310

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • Umass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Spain20 sites

  • Complexo Hospital Universitario A Coruña

    A Coruña, Galicia, 15006

  • Hospital Universitario Fundacion Alcorcon (HUFA)

    Alcorcón, Madrid, 28922

  • Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 8916

  • Hospital Son Llatzer

    Baleares, Balearic Islands, 7198

  • Hospital Universitario Vall d'Hebrón

    Barcelona, 080035

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 8036

  • Consorci Hospital General Universitari Valencia (CHGUV)

    Comunidad Valenciana, Valencia, 46014

  • Hospital General Universitario de Elche

    Elche, Alicante, 3203

  • Hospital Universitario Gregorio Marañón

    Madrid, 28016

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro-Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • H.U.V. del Rocío

    Seville, Andalusia, 41013

  • Hospital Universitario Virgen de la Macarena

    Seville, 41009

  • H.C.U.Valencia

    Valencia, 46010

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Japan16 sites

  • Medical Hospital, Tokyo Medical and Dental University

    Bunkyo-ku, Tokyo, 113-8510

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • National Kyushu Cancer Center

    Fukuoka, 811-1395

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • ST. Marianna University School of Medicine

    Kawasaki, Kanagawa, 216-8511

  • Saitama Cancer Center

    Kita-Adachi, Saitama, 362-0806

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • The cancer insitute hospital of JFCR (Japanese Foundation For Cancer Research)

    Koto-ku, Tokyo, 135-8550

  • National Hospital Organization Shikoku Cancer Center

    Matsunami, Ehime, 791-0280

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka, 537-8511

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Osaka University Hospital

    Suita, Osaka, 565-0871

  • Shizuoka Cancer Center

    Sunto, Shizuoka, 411-8777

  • Osaka Medical College Hospital

    Takatsuki, Osaka, 569-8686

Other trials in Japan

Australia15 sites

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales, 2200

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Bendigo Hospital

    Bendigo, Victoria, 3550

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • St Vincent's hospital Melbourne

    Fitzroy, New South Wales, 3065

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Western Health

    Melbourne, Victoria, 3021

  • Sunshine Coast Hospital and Health Service

    Nambour, Queensland, 4560

  • Port Macquaries Base Hospital

    Port Macquarie, New South Wales, 2444

  • Prince of Wales Hospital

    Randwick, 2031

  • Goulburn Valley Health

    Shepparton, Victoria, 3630

  • Gold Coast University Hosptial

    Southport, Queensland, 4215

  • Northern Cancer Institute

    St Leonards, New South Wales, 2065

  • The Queen Elizabeth Hospital

    Woodville, South Australia, 5011

Other trials in Australia

Germany13 sites

  • Gesundheitszentrum Wetterau

    Bad Nauheim, 61231

  • Vivantes Klinikum Am Urban

    Berlin, 10967

  • Charite - Campus Benjamin Franklin (Cbf)

    Berlin, 12203

  • DRK Kliniken Berlin Koepenick

    Berlin, 12559

  • Charité Universitätsmedizin

    Berlin, 13353

  • MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim

    Berlin, 14195

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, Saxony, 01307

  • Facharztzentrum Eppendorf

    Hamburg, 20249

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Schwerpunkpraxis für Hämatologie und Onkologie

    Magdeburg, Saxony-Anhalt, 39104

  • Universitätsklinikum Marburg

    Marburg, 35033

  • Leopoldina Krankenhaus Med. Klinik 2

    Schweinfurt, Bavaria, 97422

  • Medizinische Universitaetsklin

    Ulm, 89081

Other trials in Germany

Italy12 sites

  • Policlinico S.Orsola Malpighi, AOU di Bologna

    Bologna, 40138

  • PO di Cremona, ASST di Cremona

    Cremona, 26100

  • AUSL della Romagna, Osp. degli Infermi

    Faenza, Ravenna, 48018

  • Ospedale Santa Maria del Prato

    Feltre, Belluno, 32032

  • AO S. Martino, IRCCS, IST

    Genova, 16132

  • Irccs Irst

    Meldola, Forli, 47014

  • Ieo, Irccs

    Milan, 20141

  • AOU Policlinico di Modena

    Modena, 41124

  • Università degli studi della Campania "L.Vanvitelli"

    Naples, 80131

  • Ospedale Guglielmo da Saliceto, AUSL Piacenza

    Piacenza, 29121

  • AOU Città della Salute e della Scienza di Torino - Molinette

    Torino, 10126

  • AOU Ospedali Riuniti Umberto I - GM.Lanc

    Torrette Di Ancona, Ancona, 60126

Other trials in Italy

France11 sites

  • Centre Paul Papin

    Angers, 49055

  • Hospitalier Jean Minjoz

    Besançon, 25030

  • Hôpital Morvan - CHRU de Brest - cancérologie et d'hématolog

    Brest, 29609

  • CHU Estaing

    Clermont-Ferrand, 63003

  • Centre de Lutte Contre le Cancer (CLCC)

    Dijon, 21079

  • CHU de Nantes - Hopital Hotel Dieu

    Nantes, 44093

  • Hôpital Européen Georges Pompidou - Digestive Oncology

    Paris, 75015

  • Hôpital Privé des Côtes d'Armor - Service oncologie

    Plérin, 22190

  • Hospital of Poitiers

    Poitiers, 86021

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Rene Gauducheau

    Saint-Herblain, 44805

Other trials in France

Belgium10 sites

  • Imelda Ziekenhuis

    Bonheiden, Antwerpen, 2820

  • Imelda Ziekenhuis

    Bonheiden, Antwerpen, 2821

  • Imelda Ziekenhuis

    Bonheiden, Antwerpen, 2822

  • AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan

    Bruges, West-Vlaanderen, 8000

  • AZ Sint-Lucas - Campus Sint-Lucas

    Bruges, West-Vlaanderen, 8310

  • Hôpital Erasme

    Brussels, Brussels Capital, 1070

  • CHU de Liège - Domaine Universitaire du Sart Tilman

    Brussels, Liège, 1050

  • Grand Hôpital de Charleroi - Site Notre-Dame

    Charleroi, Hainaut, 6000

  • UZ Leuven - Campus Gasthuisberg

    Leuven, Vlaams Brabant, 3000

  • AZ Turnhout - Campus Sint-Elisabeth

    Turnhout, Antwerpen, 2300

Other trials in Belgium

Israel9 sites

  • Ha'Emek Medical Center

    Afula, 1834111

  • The Barzilai Medical Center - Oncology Institute

    Ashkelon, 7830604

  • Soroka University Medical Center

    Beersheba, 8410101

  • Shaare Zedek Medical center

    Jerusalem, 91031

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin MC - Oncology, Davidoff Center

    Petah Tikva, 49100

  • Ziv Medical Center (The Rebecca Sieff Hospital)

    Safed, 13100

  • Tel Aviv Sourasky Medical Center - Oncology

    Tel Aviv, 6423906

  • The Chaim Sheba Medical Centre - Division of Oncology

    Tel HaShomer, 52621

Other trials in Israel

South Korea8 sites

  • Yeungnam University Medical Center

    Daegu, Daegu Gwang'yeogsi, 42415

  • National Cancer Centre

    Goyang, Gyeonggido, 10408

  • Gachon University Gil Medical Center

    Incheon, Incheon Gwang'yeogsi, 21565

  • Korea University Anam Hospital

    Seoul, Seoul Teugbyeolsi, 02841

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi, 06351

  • Korea University Guro Hospital

    Seoul, Seoul Teugbyeolsi, 08308

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 120-752

  • Ajou University Hospital

    Suwon, Gyeonggido, 16499

Other trials in South Korea

Canada6 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • St. Mary's Hospital Center

    Montreal, Quebec, H3T 1M5

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, HZL 4M1

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • University of Toronto - Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Saint Michael's Hospital Li Ka Shing Knowledge Institute

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Netherlands5 sites

  • Academisch Medisch Centrum

    Amsterdam, 1055 AZ

  • Spaarne Gasthuis

    Hoofddorp, 2134 TM

  • Medisch Centrum Leeuwarden

    Leeuwarden, Provincie Friesland, 8934 AD

  • Maastricht UMC

    Maastricht, 6229 HX

  • Elizabeth Tweesteden Ziekenhuis locatie Tilburg

    Tilburg, 5042 SB

Other trials in Netherlands

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Masarykuv onkologicky ustav

    Brno, 656 53

  • FN Hradec Kralove

    Hradec Králové, Hradec Králové Region, 500 05

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

China3 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Henan Cancer Hospital

    Henan, 450008

  • Jiangsu Province Hospital

    Jiangsu, 210029

Other trials in China

Singapore3 sites

  • National University Cancer Institute

    Singapore, Central Singapore, 119228

  • National Cancer Centre

    Singapore, Central Singapore, 169610

  • Raffles Hospital

    Singapore, Central Singapore, 188770

Other trials in Singapore

Hong Kong2 sites

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong, 150001

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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).

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).

Being tested
Napabucasin, Fluorouracil, Leucovorin, Irinotecan, Bevacizumab
Keywords
Colorectal Neoplasms, Colonic Diseases, Digestive System Diseases, Digestive System Neoplasms, Gastrointestinal Diseases, Gastrointestinal Neoplasms, Intestinal Diseases, Intestinal Neoplasms, Neoplasms, Neoplasms by Histologic Type, Neoplasms by Site, Neoplasms, Glandular and Epithelial, Rectal Diseases
Medical subject headings
Colorectal Neoplasms, Colonic Diseases, Digestive System Diseases, Digestive System Neoplasms, Gastrointestinal Diseases, Gastrointestinal Neoplasms, Intestinal Diseases, Intestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NapabucasinDrug

    Also called BBI-608, BBI608, BB608

    Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).

  • FluorouracilDrug

    Also called 5-FU, Carac, Efudex, Fluoroplex

  • LeucovorinDrug

    Also called Folinic Acid

  • IrinotecanDrug

    Also called Camptosar

  • BevacizumabDrug

    Also called Avastin

Study groups in NCT02753127
Study groupRoleWhat they receive
Napabucasin plus FOLFIRIExperimentalAddition 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.
Receives: Drug: Napabucasin; Drug: Fluorouracil; Drug: Leucovorin; Drug: Irinotecan; Drug: Bevacizumab
FOLFIRIActive 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.
Receives: Drug: Fluorouracil; Drug: Leucovorin; Drug: Irinotecan; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Randomization to Date of Death from any cause or database cutoff date (28 Apr 2020) (Approximately 43 months)

Secondary outcomes (6)

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the first objective documentation of disease progression per RECIST 1.1 (PD) or death, whichever comes first.

    Measured: 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)

  2. Disease Control Rate (DCR)

    DCR is defined as the percentage of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1. The primary estimate of DCR will be based on patients with measurable disease by RECIST 1.1 at randomization

    Measured: 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)

  3. Objective Response Rate (ORR)

    ORR is defined as the proportion of patients with a documented complete response and partial response (CR + PR) based on RECIST 1.1. The primary estimate for ORR will be based on patients with measurable disease by RECIST 1.1 at randomization.

    Measured: 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)

  4. Mean Change From Baseline for Global Health Status at Time 2 (Cycle 5 Day 1) and Time 4 (Cycle 9 Day 1).

    The Quality of Life (QoL) of patients will be assessed using European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) (EORTC QLQ-30) while the patient remains on study treatment (FOLFIRI with or without BBI-608). EORTC QLQ-30 is used to assess the overall quality of life in cancer patients using 28 questions with a 4 point scale. (1 'Not at all' to 4'Very Much'); 2 questions use a 7-point sale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher overall score = better quality of life.

    Measured: From baseline at Time 2 (Cycle 5 Day 1), approximately 57 days and Time 4 (Cycle 9 Day 1), approximately 113 days

  5. Mean Change From Baseline for Physical Functioning Status at Time 2 (Cycle 5 Day 1) and Time 4 (Cycle 9 Day 1).

    The Quality of Life (QoL) of patients will be assessed using European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) (EORTC QLQ-30) while the patient remains on study treatment (FOLFIRI with or without BBI-608). EORTC QLQ-30 is used to assess the overall quality of life in cancer patients using 28 questions with a 4 point scale. (1 'Not at all' to 4'Very Much'); 2 questions use a 7-point sale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher overall score = better quality of life.

    Measured: From baseline at Time 2 (Cycle 5 Day 1) and Time 4 (Cycle 9 Day 1)

  6. Number of Patients With Adverse Events in the General Population

    All patients who have received at least one dose of either BBI-608 or FOLFIRI will be included in the safety analysis according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. The incidence of adverse events will be summarized by type of adverse event and severity.

    Measured: All adverse event are collected from date of signed informed consent until 30 days after protocol treatment discontinuation. Outcome followed until study discontinuation up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2016 (estimated)
  2. Study startJun 2016
  3. Primary completion28 Apr 2020
  4. Study completion12 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02753127
Sponsor's protocol ID
CanStem303C
Other IDs
BB608-303CRC, 2016-001627-31, 2016
Acronym
CanStem303C
Status last verified
Nov 2023
First submitted
25 Apr 2016
Last updated
15 Nov 2023
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Napabucasin, Fluorouracil and Leucovorin in people with Colorectal Cancer, run by Sumitomo Pharma America, Inc. at 211 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in United States, Spain, Japan, Australia, Germany and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Randomization to Date of Death from any cause or database cutoff date (28 Apr 2020) (Approximately 43 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02753127.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.

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