A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

NCT ID: NCT02993731

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2020-03-31

Brief Summary

This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult patients with Metastatic Pancreatic Ductal Adenocarcinoma.

Conditions

Carcinoma, Pancreatic Ductal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Napabucasin plus Nab-paclitaxel with Gemcitabine

Patients randomized to this arm will receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.

Group Type: EXPERIMENTAL

Napabucasin

Intervention Type: DRUG

Napabucasin will be administered orally, twice daily, with doses separated by approximately 12 hours.

Nab-paclitaxel

Intervention Type: DRUG

Nab-paclitaxel 125 mg/m\^2 immediately followed by gemcitabine 1000 mg/m\^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.

Gemcitabine

Intervention Type: DRUG

Nab-paclitaxel 125 mg/m\^2 immediately followed by gemcitabine 1000 mg/m\^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.

Arm 2: Nab-paclitaxel with Gemcitabine

Patients randomized to this arm will receive weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.

Group Type: ACTIVE_COMPARATOR

Nab-paclitaxel

Intervention Type: DRUG

Nab-paclitaxel 125 mg/m\^2 immediately followed by gemcitabine 1000 mg/m\^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.

Gemcitabine

Intervention Type: DRUG

Nab-paclitaxel 125 mg/m\^2 immediately followed by gemcitabine 1000 mg/m\^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.

Interventions

Napabucasin

Napabucasin will be administered orally, twice daily, with doses separated by approximately 12 hours.

Intervention Type: DRUG

Nab-paclitaxel

Nab-paclitaxel 125 mg/m\^2 immediately followed by gemcitabine 1000 mg/m\^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.

Intervention Type: DRUG

Gemcitabine

Nab-paclitaxel 125 mg/m\^2 immediately followed by gemcitabine 1000 mg/m\^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.

Intervention Type: DRUG

Other Intervention Names

BBI-608; BBI608; BB608; Abraxane; Gemzar

Eligibility Criteria

Inclusion Criteria

1. Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable International Conference on Harmonization (ICH) guidelines and local and regulatory requirements prior to the performance of any study specific procedure.

2. Must have histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma (PDAC) that is metastatic. The definitive diagnosis of metastatic PDAC will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.

3. Must not have previously received chemotherapy or any investigational agent for the treatment of PDAC. A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed for as long as last dose was administered > 6 months prior to randomization and no lingering toxicities are present.

4. Nab-paclitaxel with gemcitabine therapy is appropriate for the patient and recommended by the Investigator.

5. Patient has one or more metastatic tumors evaluable by CT scan with contrast (or MRI, if patient is allergic to CT contrast media) per RECIST 1.1. Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease must be performed within 14 days prior to randomization. Qualifying scans performed as part of standard of care prior to patient signature of the study informed consent will be acceptable as baseline scanning as long as scanning is performed < 14 days prior to randomization.

6. Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, assessed within 14 days prior to randomization. Two observers qualified to perform assessment of the performance status will be required to perform this assessment. If discrepant, the one with the most deteriorated performance status will be considered true.

7. Must have life-expectancy of > 12 weeks.

Exclusion Criteria

9. For male or female patients of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days after the final dose of nab-paclitaxel and gemcitabine or for 30 days for female patients and for 90 days for male patients, after the final napabucasin dose if nab-paclitaxel and gemcitabine were not administered.

10. Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization.

11. Patient has adequate biological parameters as demonstrated by the following blood counts at baseline (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization):

1. Absolute neutrophil count (ANC) > 1.5 x 10^9/L

2. Platelet count > 100,000/mm^3 (100 x 10^9/L). Must not have required transfusion of platelets within 1 week of baseline platelet count assessment.

3. Hemoglobin (HgB) > 9 g/dL. Must not have required transfusion of red blood cells within 1 week of baseline Hgb assessment.

12. Patient has the following blood chemistry levels at baseline (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization):

1. AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional upper limit of normal (ULN) [≤ 5 × ULN in presence of liver metastases]

2. Total bilirubin ≤ 1.5 x institutional ULN. If total bilirubin is > ULN and < 1.5 x ULN, it must be non-rising for at least 7 days.

3. Serum creatinine within normal limits or calculated clearance > 60 mL/min/1.73 m^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg. Using the Cockcroft-Gault formula). For patients with a Body Mass Index (BMI) > 30 kg/m^2, lean body weight should be used instead.

13. Patient not on anticoagulation has acceptable coagulation studies (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) below or within normal limits (+15%).

Patients on anticoagulation must have coagulation values within the therapeutic range appropriate for the anti-coagulation indication.

14. Patient has no clinically significant abnormalities on urinalysis results (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization).

15. 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.

16. Baseline laboratory evaluations must be done within 14 days prior to randomization and some must be repeated < 72 hours prior to randomization.

17. Patients requiring biliary stent placement must have biliary stent placed > 7 days prior to screening.

18. Pain symptoms should be stable (of tolerable Grade 2 or less).

19. Only patients with available archival tumor tissue 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 correlative marker assays (Correlative Studies) of this protocol may be conducted. Submission of the tissue does not have to occur prior to randomization. Where local center regulations prohibit submission of blocks of tumor tissue, two 2 mm cores of tumor from the block and 5-20 unstained slides of whole sections of representative tumor tissue are preferred. Where it is not possible to obtain two 2 mm cores of tumor from the block, 5-20 unstained slides of representative tumor tissue are also 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.

20. Patient must consent to provision of a sample of blood in order that the specific correlative marker assays (Correlative Studies) may be conducted.

21. 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.

22. Protocol treatment is to begin within 2 calendar days of patient randomization for patients randomized to Arm 1. Patients randomized to Arm 2 must begin protocol treatment within 7 calendar days of randomization.

23. 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.

1. Patients with no evidence of metastatic disease as well as patients with a local recurrence following surgical resection of primary lesion.

2. Patient has experienced a decline in ECOG performance status between Baseline visit and within 72 hours prior to randomization.

3. Patient has a > 20% decrease in serum albumin level between Baseline visit and within 72 hours prior to randomization.

4. Patient has a > 10% decrease in weight between Baseline visit and within 72 hours prior to randomization.

5. Any prior anti-cancer chemotherapy, biologic or investigational therapy for PDAC.

1. Patients receiving immunotherapy for non-cancer related treatment within < 4 weeks of first planned dose of study treatment will be excluded.

2. A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed for as long as last dose was administered > 6 months prior to randomization.

6. Major surgery within 4 weeks prior to randomization.

7. Any known brain or leptomeningeal metastases are excluded, even if treated.

8. Patients with clinically significant ascites or pleural effusions.

9. 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 nab-paclitaxel and gemcitabine and for 180 days after the last dose of nab-paclitaxel and gemcitabine.

10. Gastrointestinal disorder(s) which, in the opinion of the Principal Investigator, would significantly impede the absorption of an oral agent (e.g. active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection).

11. Unable or unwilling to swallow napabucasin capsules daily.

12. Uncontrolled inter-current 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.

1. History of cardiac disease: congestive heart failure (CHF) > New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction or coronary stenting within 6 months prior to randomization; 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).

2. 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.

3. Significant vascular disease (e.g., aortic aneurysm, aortic dissection, symptomatic peripheral vascular disease including claudication, Leo Buerger's disease). Treated peripheral vascular disease that is stable for at least 6 months is allowed.

4. Evidence of bleeding diathesis or clinically significant coagulopathy.

5. 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 randomization.

6. Patients with clinically significant abnormalities on urinalysis at < 14 days prior to randomization.

7. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization.

8. Ongoing serious, non-healing wound, ulcer, or bone fracture.

9. Known infection with Human Immunodeficiency Virus (HIV), and/or active infection with hepatitis B, or hepatitis C.

10. History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.

11. History of hemolytic-uremic syndrome.

12. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).

13. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders that could compromise the patient's safety or the study data integrity.

13. Known hypersensitivity to gemcitabine, taxanes or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the product or comparator Summary of Product Characteristics or Prescribing Information. Possible hypersensitivity to napabucasin or one of the excipients which include the azo dyes sunset yellow and allura red.

14. Neurosensory neuropathy > grade 2 at baseline.

15. Uncontrolled chronic diarrhea > grade 2 at baseline.

16. Patients being treated with Warfarin.

17. Patients with active, uncontrolled bacterial, viral or fungal infection(s) requiring systemic therapy

18. 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 by surgery alone or surgery plus radiotherapy with no evidence of disease continuously for > 5 years.

19. Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.

20. Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol, including patients with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol. Patients planning to take a vacation for 14 or more consecutive days during the course of the study are ineligible.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Clearview Cancer Institute (CCI)

Huntsville, Alabama, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Mayo Clinic

Phoenix, Arizona, United States

Highlands Oncology Group

Fayetteville, Arkansas, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, United States

University of Southern California

Los Angeles, California, United States

St. Joseph Hospital of Orange

Orange, California, United States

Torrance Health Association DBA Torrance Memorial

Redondo Beach, California, United States

UC Davis

Sacramento, California, United States

UCLA Medical Center Santa Monica Hematology And Oncology

Santa Monica, California, United States

Kaiser Permanente - Vallejo Medical Center

Vallejo, California, United States

Norwalk Hospital The C Anthony and Jean Whittingham Cancer Center

Norwalk, Connecticut, United States

The C Anthony and Jean Whittingham Cancer Center

Norwalk, Connecticut, United States

Helen F. Graham Cancer Center

Newark, Delaware, United States

Georgetown University Medical Center (GUMC)

Washington D.C., District of Columbia, United States

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, United States

Memorial Regional Hospital

Hollywood, Florida, United States

Mayo Clinic Cancer Center

Jacksonville, Florida, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

UF Health Cancer Center - Orlando Health

Orlando, Florida, United States

Florida Cancer Specialists North

St. Petersburg, Florida, United States

Florida Cancer Specialists East Region

Wellington, Florida, United States

University Cancer & Blood Center

Athens, Georgia, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Columbus Regional Research Institute

Columbus, Georgia, United States

Saint Alphonsus Health System

Boise, Idaho, United States

NorthShore University Health Systems

Evanston, Illinois, United States

Ingalls Cancer Research Center

Harvey, Illinois, United States

Carle Cancer Center CCOP

Urbana, Illinois, United States

Northwestern Medicine Regional Medical Group

Warrenville, Illinois, United States

Parkview Physician Group (PPG)

Fort Wayne, Indiana, United States

Indiana University - Melvin and Bren Simon Cancer

Indianapolis, Indiana, United States

Cotton O'Neil Cancer Center

Topeka, Kansas, United States

Cancer Center of Kansas

Wichita, Kansas, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Louisiana Hematology Oncology Associates (LHOA)

Baton Rouge, Louisiana, United States

Maine Center for Cancer Medicine - Scarborough

Scarborough, Maine, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

St. Luke's Hospital of Duluth

Duluth, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Metro MN Clinical Oncology Research Consortium

Saint Louis Park, Minnesota, United States

Jackson Oncology Associates

Jackson, Mississippi, United States

University of Missouri - Ellis Fischel Cancer Cent

Columbia, Missouri, United States

Saint Luke's Hospital

Kansas City, Missouri, United States

HCA Midwest Division (Kansas City)

Kansas City, Missouri, United States

Mercy Clinic - Cancer & Hematology

Springfield, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

St. Vincent Frontier Cancer Center

Billings, Montana, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

UNM Cancer Research and Treatment Center

Albuquerque, New Mexico, United States

San Juan Oncology Associates

Farmington, New Mexico, United States

Basset Medical Center

Cooperstown, New York, United States

North Shore Hematology Oncology Associates PC

East Setauket, New York, United States

Hematology Oncology Associates of Central New York

East Syracuse, New York, United States

Clinical Research Alliance

Lake Success, New York, United States

Weill Cornell Medicine/ NewYork-Presbyterian

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Stony Brook University

Stony Brook, New York, United States

Montefiore Cancer Center

The Bronx, New York, United States

UNC Chapel Hill / Lineberger Comprehensive Cancer

Chapel Hill, North Carolina, United States

Southeastern Medical Oncology Center

Goldsboro, North Carolina, United States

Cone Health Cancer Center

Greensboro, North Carolina, United States

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States

Wake Forest Baptist Hospital

Winston-Salem, North Carolina, United States

Gabrail Cancer Center (GCC) - Canton Facility

Canton, Ohio, United States

Toledo Clinic Cancer Centers

Toledo, Ohio, United States

Cancer Center of Southwest Oklahoma

Lawton, Oklahoma, United States

Mercy Clinic Oncology and Hematology - McAuley

Oklahoma City, Oklahoma, United States

Kaiser Permanente - Westside Medical Office

Hillsboro, Oregon, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Fox Chase Cancer Center (FCCC) - Philadelphia

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Charleston Hematology Oncology Associates

Charleston, South Carolina, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Saint Francis Cancer Center

Greenville, South Carolina, United States

GHS Cancer Institute

Greenville, South Carolina, United States

Avera Medical Group

Sioux Falls, South Dakota, United States

Tennessee Oncology Chattanooga

Chattanooga, Tennessee, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

SCRI - Tennessee Oncology

Nashville, Tennessee, United States

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Bon Secours Cancer Institute Medical Oncology

Midlothian, Virginia, United States

Virginia Cancer Institute

Richmond, Virginia, United States

Oncology and Hematology Associates of Southwest Virginia

Roanoke, Virginia, United States

The Everett Clinic

Everett, Washington, United States

MultiCare Institute for Research and Innovation

Tacoma, Washington, United States

West Virginia University Mary Babb Randolph Cancer Center (MBRCC)

Morgantown, West Virginia, United States

HSHS St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Green Bay Oncology, Ltd. - West Green Bay

Green Bay, Wisconsin, United States

Aurora St. Luke's Medical Center - Vince Lombardi

Milwaukee, Wisconsin, United States

Border Medical Oncology

East Albury, New South Wales, Australia

Macquarie University Hospital

Sydney, New South Wales, Australia

ICON Cancer Care

South Brisbane, South Australia, Australia

Cabrini Hospital

Malvern, Victoria, Australia

Blacktown Cancer and Haematology Centre

Blacktown, , Australia

Border Medical Oncology

East Albury, , Australia

The Austin Hospital

Heidelberg, , Australia

Cabrini Hospital

Malvern, , Australia

Sir Charles Gairdner Hospital

Nedlands, , Australia

Prince of Wales Private Hospital

Randwick, , Australia

ICON Cancer Care

South Brisbane, , Australia

Macquarie University Hospital

Sydney, , Australia

The Tweed Hospital

Tweed Heads, , Australia

Sydney Adventist Hospital

Wahroonga, , Australia

LKH Universitätsklinikum Graz

Graz, , Austria

Landeskrankenhaus Medical University Innsbruck

Innsbruck, , Austria

Landeskrankenhaus Feldkirch

Rankweil, , Austria

Universitatsklinik far Innere Medizin III

Salzburg, , Austria

Medical University Vienna

Vienna, , Austria

ULB Erasme

Brussels, , Belgium

Antwerp University Hospital

Edegem, , Belgium

UZ Ghent

Ghent, , Belgium

UZ Brussel

Jette, , Belgium

UZ Leuven

Leuven, , Belgium

CHU de Liege

Liège, , Belgium

CHU Dinant Godinne

Yvoir, , Belgium

Dr. Everett Chalmers Regional Hospital

Fredericton, New Brunswick, Canada

The Atlantic Clinical Cancer Research Unit (ACCRU)

Halifax, Nova Scotia, Canada

Centre Hospitalier de St. Mary

Pointe-Claire, Quebec, Canada

Ciusssmcq

Trois-Rivières, Quebec, Canada

Cross Cancer Institute

Edmonton, , Canada

University of Toronto - St. Michael's Hospital

Toronto, , Canada

Beijing Cancer Hospital

Beijing, , China

Chinese PLA General Hospital

Beijing, , China

Jilin Cancer Hospital

Changchun, , China

The first hospital of jilin university

Changchun, , China

Fujian Medical University Union Hospital

Fuzhou, , China

Cancer Center of Guangzhou Medical University

Guangzhou, , China

Guangdong General Hospital

Guangzhou, , China

The First Affiliated Hospital Zhejiang University

Hangzhou, , China

The Second Affiliated Hospital Zhejiang University

Hangzhou, , China

Sir Run Shaw Hospital School of Medicine Zhejiang University

Hangzhou, , China

Zhejiang Cancer Hospital

Hangzhou, , China

Harbin Medical University Cancer Hospital

Harbin, , China

The First Affiliated Hospital of Anhui Medical University

Hefei, , China

The Second Affiliated Hospital of Anhui Medical University

Hefei, , China

The 81 Hospital of the Chinese Peoples Liberation Army

Nanjing, , China

Jiangsu Cancer Hospital

Nanjing, , China

The Affiliated Hospital of Qingdao University

Qingdao, , China

Fudan University Shanghai Cancer Center

Shanghai, , China

Huashan Hospital

Shanghai, , China

Ren Ji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, , China

East Hospital of Tongji University

Shanghai, , China

The First Affiliated Hospital of Soochow University

Suzhou, , China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, , China

The First Affiliated Hospital of Xian Jiao Tong University

Xi'an, , China

General Hospital of Ningxia Medical University

Yinchuan, , China

Henan Cancer Hospital

Zhengzhou, , China

Onkologicke oddeleni

Benešov, , Czechia

Fakultni nemocnice Brno Interni hematoonkologicka klinika

Brno, , Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

University Hospital Olomouc

Olomouc, , Czechia

Onkologické oddělení

Zlín, , Czechia

Hôpital Sud - CHU Amiens Picardie

Amiens, , France

Hôpital Trousseau, CHRU de Tours

Chambray-lès-Tours, , France

Hopital Edourard Herriot

Lyon, , France

CHU-Hôtel Dieu

Nantes, , France

Centre Antoine Lacassagne

Nice, , France

Hopital Europeen Georges Pompidou

Paris, , France

Poitiers University Hospital

Poitiers, , France

Centre Eugene Marquis

Rennes, , France

Clinique Saint Anne

Strasbourg, , France

Hopital Civil de strasbourg

Strasbourg, , France

Institute de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, , France

Gesundheitszentrum St. Marien GmbH

Amberg, , Germany

University Hospital Bonn

Bonn, , Germany

Klinikum Chemnitz

Chemnitz, , Germany

Krankenhaus Nordwest

Frankfurt am Main, , Germany

Medizinische Hochschule

Hanover, , Germany

SLK-Kliniken Heilbronn GmbH

Heilbronn, , Germany

Universitätsmedizin Mannheim

Mannheim, , Germany

Klinikum Bogenhausen

München, , Germany

Klinikum Oldenburg AöR - UK für Innere Medizin

Oldenburg, , Germany

Fondazione Poliambulanza

Brescia, , Italy

Istituto Ricerca e la Cura del Cancro (IRCC)

Candiolo, , Italy

AOU Mater Domini

Catanzaro, , Italy

Ospedale degli Infermi

Faenza, , Italy

Santa Maria de Prato Hospital

Feltre, , Italy

IRCCS - Studio e la Cura dei Tumori

Meldola, , Italy

IRCCS Ospedale San Raffaele

Milan, , Italy

AO SM Misericordia

Perugia, , Italy

IRCCS Azienda Ospedaliera S.Maria Nuova

Reggio Emilia, , Italy

Ospedale degli Infermi

Rimini, , Italy

Dermatological Hospital San Lazzaro

Torino, , Italy

ASST Settelaghi

Varese, , Italy

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Shikoku Cancer Center

Matsuyama, Ehime, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Tochigi Cancer Center

Utsunomiya, Tochigi, Japan

University of Tokyo Hospital

Bunkyō-Ku, Tokyo, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital Of JFCR

Koto-Ku, Tokyo, Japan

Kyorin University Hopsital

Mitaka, Tokyo, Japan

Kyoto University Hospital

Kyoto, , Japan

Osaka International Cancer Institute

Osaka, , Japan

Saitama Cancer Center

Saitama, , Japan

Shizuoka Cancer Center

Shizuoka, , Japan

Medisch Centrum Leeuwarden (MCL)

Leeuwarden, , Netherlands

Zuyderland Medical Center

Sittard, , Netherlands

University Medical Center Utrecht

Utrecht, , Netherlands

Isala Ziekenhuis

Zwolle, , Netherlands

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Centrum Onkologii-Instytut im.M.Sklodowskiej-Curie

Gliwice, , Poland

Przychodnia Lekarska KOMED

Konin, , Poland

Klinika Chirurgii Onkologicznej

Lublin, , Poland

Centrum Onkologii Ziemi Lubelskiej

Lublin, , Poland

Samodzielny Publiczny Szpital Kliniczny

Poznan, , Poland

Wojewodzki Szpital Zespolony

Torun, , Poland

Fundação Champalimaud

Lisbon, , Portugal

Hospital da Luz

Lisbon, , Portugal

Centro Hospitalar Lisboa Norte

Lisbon, , Portugal

Centro Hospitalar do Porto, E.P.E

Porto, , Portugal

IPO Porto Francisco Gentil, E.P.E.

Porto, , Portugal

Centro Hospitalar Entre Douro e Vouga

Santa Maria da Feira, , Portugal

Kursk Regional Clinical Oncology Dispensary

Kislino, Kursk Oblast, Russia

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, , Russia

Republican Clinical Oncology Dispensary

Cheboksary, , Russia

Llc Evimed

Chelyabinsk, , Russia

Railway Clinical Hospital on station Chelyabinsk

Chelyabinsk, , Russia

Republic Clinical Oncology Dispensary

Kazan', , Russia

N.N. Blokhin Russian Cancer Research Center

Moscow, , Russia

Privolzhsk District Medical Center

Nizhny Novgorod, , Russia

Budgetary Healthcare Institution of Omsk Region

Omsk, , Russia

Orenburg Regional Clinical Oncology Dispensary

Orenburg, , Russia

Pyatigorsk Oncology Dispensary

Pyatigorsk, , Russia

St.Petersburg Medical Universitet n.a. I.P. Pavlov

Saint Petersburg, , Russia

FSBI "Russian Research Centre of Radiology and Surgical Technologies"

Saint Petersburg, , Russia

City Clinical Oncology Dispensary

Saint Petersburg, , Russia

Multi-type clinic 'REAVIZ'

Samara, , Russia

National Research Mordovia State University

Saransk, , Russia

National Cancer Centre Singapore

Singapore, , Singapore

Tan Tock Seng Hospital

Singapore, , Singapore

Seoul national University Bundang Hospital

Gyeonggi-do, , South Korea

Chonnam National University Hwasun Hospital

Jeongnam, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul St. Mary's Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Hospital Vall d´Hebron

Barcelona, , Spain

Hospital Clínico y Provincial de Barcelona

Barcelona, , Spain

(ICO) Hospital Duran i Reynals

Barcelona, , Spain

Hospital Universitario Germans Trias i Pujol

Barcelona, , Spain

Hospital Universitario Gregorio Marañón

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Centro Integral Oncologico Clara Campal

Madrid, , Spain

Hospital Universitario Puerta de Hierro

Madrid, , Spain

Hospital Universitario Fundacion Alcorcon

Madrid, , Spain

Hospital Regional Universitario de Málaga

Málaga, , Spain

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

LinKou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Zaytsev Institute General and Urgent Surgery of National Academy Medical Science of Ukraine

Kharkiv, , Ukraine

National Institute of Cancer

Kyiv, , Ukraine

Countries

United States; Australia; Austria; Belgium; Canada; China; Czechia; France; Germany; Italy; Japan; Netherlands; Poland; Portugal; Russia; Singapore; South Korea; Spain; Taiwan; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CanStem111P

Identifier Type: -

Identifier Source: org_study_id