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A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CanStem303C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02753127
Recruitment Status : Active, not recruiting
First Posted : April 27, 2016
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Biomedical, Inc

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).

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Napabucasin Drug: Fluorouracil Drug: Leucovorin Drug: Irinotecan Drug: Bevacizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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).
Study Start Date : June 2016
Estimated Primary Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Napabucasin plus FOLFIRI
Addition 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.
Drug: Napabucasin
Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).
Other Names:
  • BBI-608
  • BBI608
  • BB608

Drug: Fluorouracil
Other Names:
  • 5-FU
  • Carac
  • Efudex
  • Fluoroplex
  • Adrucil

Drug: Leucovorin
Other Name: Folinic Acid

Drug: Irinotecan
Other Name: Camptosar

Drug: Bevacizumab
Other Name: Avastin

Active Comparator: FOLFIRI
Addition 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.
Drug: Fluorouracil
Other Names:
  • 5-FU
  • Carac
  • Efudex
  • Fluoroplex
  • Adrucil

Drug: Leucovorin
Other Name: Folinic Acid

Drug: Irinotecan
Other Name: Camptosar

Drug: Bevacizumab
Other Name: Avastin




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 36 months ]
    To assess the effect of napabucasin plus biweekly FOLFIRI versus biweekly FOLFIRI on the Overall Survival of patients with previously treated metastatic colorectal cancer in the General Population and in the pSTAT3(+) Subpopulation


Secondary Outcome Measures :
  1. Progression Free Survival in the General Population and pSTAT3(+) Subpopulation [ Time Frame: 36 months ]
    Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.

  2. Objective Response Rate in the General Population and pSTAT3(+) Subpopulation [ Time Frame: 36 months ]
    Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1.

  3. Disease Control Rate in the General Population and pSTAT3(+) Subpopulation [ Time Frame: 36 months ]
    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

  4. Number of Patients with Adverse Events in the General Population and pSTAT3(+) Subpopulation [ Time Frame: 36 months ]
    All patients who have received at least one dose of napabucasin 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.

  5. Quality of Life (QoL) in the General Population and pSTAT3(+) Subpopulation [ Time Frame: 36 months ]
    QoL will be measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) in patients with pretreated metastatic CRC treated with napabucasin plus biweekly FOLFIRI versus biweekly FOLFIRI.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Must have histologically confirmed advanced CRC that is metastatic.
  3. 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.
  4. FOLFIRI therapy is appropriate for the patient and is recommended by the Investigator.
  5. 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.
  6. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  7. Must be ≥ 18 years of age.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. Must have total bilirubin ≤ 1.5 × institutional ULN [≤ 2.0 x ULN in presence of liver metastases] within 14 days prior to randomization.
  13. 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.
  14. Must have absolute neutrophil count ≥ 1.5 x 10^9/L within 14 days prior to randomization.
  15. 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.
  16. 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.
  17. Other baseline laboratory evaluations, listed in Section 6.0, must be done within 14 days prior to randomization.
  18. 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.
  19. Patient must consent to provision of a sample of blood in order that the specific correlative marker assays may be conducted.
  20. 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.
  21. Protocol treatment is to begin within 2 calendar days of patient randomization.
  22. 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.

Exclusion Criteria:

  1. 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.
  2. More than one prior chemotherapy regimen administered in the metastatic setting.
  3. Major surgery within 4 weeks prior to randomization.
  4. Patients with any known brain or leptomeningeal metastases are excluded, even if treated.
  5. 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.
  6. 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).
  7. Unable or unwilling to swallow napabucasin capsules daily.
  8. Prior treatment with napabucasin.
  9. 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.
  10. Known hypersensitivity to 5-fluorouracil/leucovorin
  11. Known dihydropyrimidine dehydrogenase (DPD) deficiency
  12. Known hypersensitivity to irinotecan
  13. Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis)
  14. Patients receiving treatment with St. John's wort or Phenytoin.
  15. Patients who plan to receive yellow fever vaccine during the course of the study treatment.
  16. Abnormal glucuronidation of bilirubin, known Gilbert's syndrome
  17. Patients with QTc interval > 470 milliseconds
  18. 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.
  19. 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.
  20. Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
  21. Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753127


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Locations
Layout table for location information
United States, Alabama
Alabama Oncology
Birmingham, Alabama, United States, 35223
United States, Arizona
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States, 85771
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
City of Hope- Comprehensive Care Center
Duarte, California, United States, 91010
University of California-San Diego/Moores UCSD Cancer Center
La Jolla, California, United States, 92093
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, United States, 90017
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
UCLA Hematology Oncology Santa Monica
Santa Monica, California, United States, 90404
St. Joseph Heritage Healthcare
Santa Rosa, California, United States, 95405
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
St Mary's Hospital & Regional Med Center
Grand Junction, Colorado, United States, 81501
United States, Delaware
Medical Oncology Hematology Consultants, PA
Newark, Delaware, United States, 19713
United States, Florida
Florida Cancer Specialists & Research Institute Fort Myers
Fort Myers, Florida, United States, 33901
Memorial Cancer Institute at Memorial Hospital
Hollywood, Florida, United States, 33021
Baptist Health Medical Group Oncology, LLC
Miami, Florida, United States, 33176
Sarah Cannon Research Institution
Saint Petersburg, Florida, United States, 33705
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
Piedmont Cancer Institute, PC
Atlanta, Georgia, United States, 30318
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Suburban Hematology-Oncology Associates, PC - Lawrenceville
Lawrenceville, Georgia, United States, 30046
United States, Illinois
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
Northshore University Healthsystem
Evanston, Illinois, United States, 60201
Healthcare Research Network III, LLC
Tinley Park, Illinois, United States, 60487
Northwestern Medicine Cancer Center
Warrenville, Illinois, United States, 60555
United States, Indiana
Parkview Research Center
Fort Wayne, Indiana, United States, 46845
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
Michiana Hematology Oncology, PC
Mishawaka, Indiana, United States, 46545
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, Massachusetts
Dana Farber
Boston, Massachusetts, United States, 02215
Umass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States
United States, Minnesota
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States, 55404
Mayo Clinic Arizona
Rochester, Minnesota, United States, 55905
United States, Missouri
Research Medical Center
Kansas City, Missouri, United States, 64132
Missouri Baptist Medical Center ACCRU Network Site
Saint Louis, Missouri, United States, 63131
United States, Nebraska
Saint Francis Cancer Treatment Center
Grand Island, Nebraska, United States, 68803
Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Cancer Research Network of Nebraska / Oncology Associates PC
Omaha, Nebraska, United States, 68118
Tennessee Oncology PLLC
Omaha, Nebraska, United States, 68118
United States, New Hampshire
Darthmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Carol G. Simon Cancer Center
Morristown, New Jersey, United States, 07962
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Roswell Park Cancer Center
Buffalo, New York, United States, 14263
North Shore Hematology Oncology Associates
East Setauket, New York, United States, 11733
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Toledo Clinic Cancer Centers
Toledo, Ohio, United States, 43623
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29412
United States, South Dakota
Sanford Cancer Center
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
West Cancer Center
Memphis, Tennessee, United States, 38138
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology-Austin Midtown
Austin, Texas, United States, 75705
Texas Oncology - Dallas Center
Dallas, Texas, United States, 75203
Texas Oncology - Denton South
Denton, Texas, United States, 76210
Texas Oncology - Fort Worth
Fort Worth, Texas, United States, 76104
Millenium Oncology
Houston, Texas, United States, 77090
Texas Health Physicians Group
Plano, Texas, United States, 75093
Texas Oncology-San Antonio
San Antonio, Texas, United States, 78217
Texas Oncology - Tyler
Tyler, Texas, United States, 75702
Texas Oncology - Wichita Falls Texoma Cancer Center
Wichita Falls, Texas, United States, 76310
United States, Utah
Northern Utah Associates
Ogden, Utah, United States, 84403
United States, Virginia
US Oncology - Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States, 22060
Virginia Oncology Associates
Hampton, Virginia, United States, 23666
Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
United States, Washington
Virginia Mason
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States, 98684
Australia, New South Wales
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia, 2200
St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
St Vincent's hospital Melbourne
Fitzroy, New South Wales, Australia, 3065
Port Macquaries Base Hospital
Port Macquarie, New South Wales, Australia, 2444
Northern Cancer Institute
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Sunshine Coast Hospital and Health Service
Nambour, Queensland, Australia, 4560
Gold Coast University Hosptial
Southport, Queensland, Australia, 4215
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
The Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Australia, Victoria
Bendigo Hospital
Bendigo, Victoria, Australia, 3550
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia, 3199
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Western Health
Melbourne, Victoria, Australia, 3021
Goulburn Valley Health
Shepparton, Victoria, Australia, 3630
Australia
Prince of Wales Hospital
Randwick, Australia, 2031
Belgium
Imelda Ziekenhuis
Bonheiden, Antwerpen, Belgium, 2820
Imelda Ziekenhuis
Bonheiden, Antwerpen, Belgium, 2821
Imelda Ziekenhuis
Bonheiden, Antwerpen, Belgium, 2822
AZ Turnhout - Campus Sint-Elisabeth
Turnhout, Antwerpen, Belgium, 2300
Hôpital Erasme
Bruxelles, Brussels Capital Region, Belgium, 1070
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi, Hainaut, Belgium, 6000
CHU de Liège - Domaine Universitaire du Sart Tilman
Bruxelles, Liège, Belgium, 1050
UZ Leuven - Campus Gasthuisberg
Leuven, Vlaams Brabant, Belgium, 3000
AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan
Brugge, West-Vlaanderen, Belgium, 8000
AZ Sint-Lucas - Campus Sint-Lucas
Brugge, West-Vlaanderen, Belgium, 8310
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
University of Toronto - Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Saint Michael's Hospital Li Ka Shing Knowledge Institute
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
St. Mary's Hospital Center
Montréal, Quebec, Canada, H3T 1M5
Hopital Notre-Dame du CHUM
Montréal, Quebec, Canada, HZL 4M1
China
Beijing Cancer Hospital
Beijing, China, 100142
Henan Cancer Hospital
Henan, China, 450008
Jiangsu Province Hospital
Jiangsu, China, 210029
Czechia
FN Hradec Kralove
Hradec Králové, Královéhradecký Kraj, Czechia, 500 05
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Masarykuv onkologicky ustav
Brno, Czechia, 656 53
Vseobecna fakultni nemocnice v Praze
Prague, Czechia, 128 08
France
Centre Paul Papin
Angers, France, 49055
Hospitalier Jean Minjoz
Besançon, France, 25030
Hôpital Morvan - CHRU de Brest - cancérologie et d'hématolog
Brest, France, 29609
CHU Estaing
Clermont Ferrand, France, 63003
Centre de Lutte Contre le Cancer (CLCC)
Dijon, France, 21079
CHU de Nantes - Hopital Hotel Dieu
Nantes, France, 44093
Hôpital Européen Georges Pompidou - Digestive Oncology
Paris, France, 75015
Hôpital Privé des Côtes d'Armor - Service oncologie
Plérin, France, 22190
Hospital of Poitiers
Poitiers, France, 86021
Centre Eugene Marquis
Rennes, France, 35042
Centre Rene Gauducheau
Saint-Herblain, France, 44805
Germany
Leopoldina Krankenhaus Med. Klinik 2
Schweinfurt, Bayern, Germany, 97422
Schwerpunkpraxis für Hämatologie und Onkologie
Magdeburg, Sachsen-Anhalt, Germany, 39104
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Sachsen, Germany, 01307
Gesundheitszentrum Wetterau
Bad Nauheim, Germany, 61231
Vivantes Klinikum Am Urban
Berlin, Germany, 10967
Charite - Campus Benjamin Franklin (Cbf)
Berlin, Germany, 12203
DRK Kliniken Berlin Koepenick
Berlin, Germany, 12559
Charité Universitätsmedizin
Berlin, Germany, 13353
MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin, Germany, 14195
Facharztzentrum Eppendorf
Hamburg, Germany, 20249
Asklepios Klinik Altona
Hamburg, Germany, 22763
Universitätsklinikum Marburg
Marburg, Germany, 35033
Medizinische Universitaetsklin
Ulm, Germany, 89081
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong, 150001
Queen Mary Hospital
Hong Kong, Hong Kong
Israel
Ha'Emek Medical Center
Afula, Israel, 1834111
The Barzilai Medical Center - Oncology Institute
Ashkelon, Israel, 7830604
Soroka University Medical Center
Be'er Sheva, Israel, 8410101
Shaare Zedek Medical center
Jerusalem, Israel, 91031
Meir Medical Center
Kefar Saba, Israel, 4428164
Rabin MC - Oncology, Davidoff Center
Petah tikva, Israel, 49100
Ziv Medical Center (The Rebecca Sieff Hospital)
Safed, Israel, 13100
The Chaim Sheba Medical Centre - Division of Oncology
Tel HaShomer, Israel, 52621
Tel Aviv Sourasky Medical Center - Oncology
Tel-Aviv, Israel, 6423906
Italy
AOU Ospedali Riuniti Umberto I - GM.Lanc
Torrette Di Ancona, Ancona, Italy, 60126
Ospedale Santa Maria del Prato
Feltre, Belluno, Italy, 32032
Irccs Irst
Meldola, Forli, Italy, 47014
AUSL della Romagna, Osp. degli Infermi
Faenza, Ravenna, Italy, 48018
Policlinico S.Orsola Malpighi, AOU di Bologna
Bologna, Italy, 40138
PO di Cremona, ASST di Cremona
Cremona, Italy, 26100
AO S. Martino, IRCCS, IST
Genova, Italy, 16132
Ieo, Irccs
Milano, Italy, 20141
AOU Policlinico di Modena
Modena, Italy, 41124
Università degli studi della Campania "L.Vanvitelli"
Napoli, Italy, 80131
Ospedale Guglielmo da Saliceto, AUSL Piacenza
Piacenza, Italy, 29121
AOU Città della Salute e della Scienza di Torino - Molinette
Torino, Italy, 10126
Japan
Aichi Cancer Center Hospital
Nagoya, Aichi, Japan, 464-8681
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center
Matsunami, Ehime, Japan, 791-0280
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Kobe City Medical Center General Hospital
Kobe, Hyogo, Japan, 650-0047
ST. Marianna University School of Medicine
Kawasaki, Kanagawa, Japan, 216-8511
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Osaka Medical College Hospital
Takatsuki, Osaka, Japan, 569-8686
Saitama Cancer Center
Kita-Adachi, Saitama, Japan, 362-0806
Shizuoka Cancer Center
Sunto, Shizuoka, Japan, 411-8777
Medical Hospital, Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan, 113-8510
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
The cancer insitute hospital of JFCR (Japanese Foundation For Cancer Research)
Koto-ku, Tokyo, Japan, 135-8550
National Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan, 537-8511
National Hospital Organization Osaka National Hospital
Osaka, Japan, 540-0006
Korea, Republic of
Yeungnam University Medical Center
Daegu, Daegu Gwang'yeogsi, Korea, Republic of, 42415
National Cancer Centre
Goyang, Gyeonggido, Korea, Republic of, 10408
Ajou University Hospital
Suwon, Gyeonggido, Korea, Republic of, 16499
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi, Korea, Republic of, 21565
Korea University Anam Hospital
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 02841
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Korea University Guro Hospital
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 120-752
Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Friesland, Netherlands, 8934 AD
Academisch Medisch Centrum
Amsterdam, Netherlands, 1055 AZ
Spaarne Gasthuis
Hoofddorp, Netherlands, 2134 TM
Maastricht UMC
Maastricht, Netherlands, 6229 HX
Elizabeth Tweesteden Ziekenhuis locatie Tilburg
Tilburg, Netherlands, 5042 SB
Singapore
National University Cancer Institute
Singapore, Central Singapore, Singapore, 119228
National Cancer Centre
Singapore, Central Singapore, Singapore, 169610
Raffles Hospital
Singapore, Central Singapore, Singapore, 188770
Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain, 3203
H.U.V. del Rocío
Sevilla, Andalucía, Spain, 41013
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33011
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 8916
Complexo Hospital Universitario A Coruña
A Coruña, Galicia, Spain, 15006
Hospital Universitario Fundacion Alcorcon (HUFA)
Alcorcón, Madrid, Spain, 28922
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, Spain, 28222
Consorci Hospital General Universitari Valencia (CHGUV)
Comunidad Valenciana, Valencia, Spain, 46014
Hospital Son Llatzer
Baleares, Spain, 7198
Hospital Universitario Vall d'Hebrón
Barcelona, Spain, 080035
Hospital del Mar
Barcelona, Spain, 08003
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 8036
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28016
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Hospital Universitario Virgen de la Macarena
Sevilla, Spain, 41009
H.C.U.Valencia
Valencia, Spain, 46010
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Boston Biomedical, Inc

Layout table for additonal information
Responsible Party: Boston Biomedical, Inc
ClinicalTrials.gov Identifier: NCT02753127     History of Changes
Other Study ID Numbers: CanStem303C
BB608-303CRC ( Other Identifier: Boston Biomedical, Inc. )
2016-001627-31 ( EudraCT Number )
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Keywords provided by Boston Biomedical, Inc:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Irinotecan
Fluorouracil
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors