A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma (CanStem111P)

November 13, 2023 updated by: Sumitomo Pharma America, Inc.

A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

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.

Study Overview

Status

Completed

Conditions

Carcinoma, Pancreatic Ductal

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1134

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Blacktown, Australia, 2148
    - Blacktown Cancer and Haematology Centre
  - East Albury, Australia, 2640
    - Border Medical Oncology
  - Heidelberg, Australia, 3084
    - The Austin Hospital
  - Malvern, Australia, 3144
    - Cabrini Hospital
  - Nedlands, Australia, 6009
    - Sir Charles Gairdner Hospital
  - Randwick, Australia, 2031
    - Prince of Wales Private Hospital
  - South Brisbane, Australia, 4101
    - ICON Cancer Care
  - Sydney, Australia, 2109
    - Macquarie University Hospital
  - Tweed Heads, Australia, 2485
    - The Tweed Hospital
  - Wahroonga, Australia, 2076
    - Sydney Adventist Hospital
- New South Wales
  - East Albury, New South Wales, Australia, 2109
    - Border Medical Oncology
  - Sydney, New South Wales, Australia, 2109
    - Macquarie University Hospital
- South Australia
  - South Brisbane, South Australia, Australia, 4101
    - ICON Cancer Care
- Victoria
  - Malvern, Victoria, Australia, 3144
    - Cabrini Hospital
Austria
- - Graz, Austria, 8036
    - LKH Universitätsklinikum Graz
  - Innsbruck, Austria, 6020
    - Landeskrankenhaus Medical University Innsbruck
  - Rankweil, Austria, 6830
    - Landeskrankenhaus Feldkirch
  - Salzburg, Austria, 5020
    - Universitatsklinik far Innere Medizin III
  - Vienna, Austria, 1090
    - Medical University Vienna
Belgium
- - Bruxelles, Belgium, 13-1070
    - ULB Erasme
  - Edegem, Belgium, B-2650
    - Antwerp University Hospital
  - Gent, Belgium, 9000
    - UZ Ghent
  - Jette, Belgium, 1070
    - UZ Brussel
  - Leuven, Belgium, 3000
    - UZ Leuven
  - Liège, Belgium, 4000
    - CHU de Liège
  - Yvoir, Belgium, 5530
    - CHU Dinant Godinne
Canada
- - Edmonton, Canada, T6G 1Z2
    - Cross Cancer Institute
  - Toronto, Canada, M5B 1W8
    - University of Toronto - St. Michael's Hospital
- New Brunswick
  - Fredericton, New Brunswick, Canada, E3B 5N5
    - Dr. Everett Chalmers Regional Hospital
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1C2
    - The Atlantic Clinical Cancer Research Unit (ACCRU)
- Quebec
  - Pointe-Claire, Quebec, Canada, H9R 2Y2
    - Centre Hospitalier de St. Mary
  - Trois-Rivières, Quebec, Canada, G8Z 3R9
    - Ciusssmcq
China
- - Beijing, China, 100142
    - Beijing Cancer Hospital
  - Beijing, China, 100853
    - Chinese PLA General Hospital
  - Changchun, China, 130021
    - The First Hospital of Jilin University
  - Changchun, China, 130021
    - Jilin Cancer Hospital
  - Fuzhou, China, 350001
    - Fujian Medical University Union Hospital
  - Guangzhou, China, 510095
    - Cancer Center of Guangzhou Medical University
  - Guangzhou, China, 510180
    - Guangdong General Hospital
  - Hangzhou, China, 310022
    - Zhejiang Cancer Hospital
  - Hangzhou, China, 310003
    - The First Affiliated Hospital Zhejiang University
  - Hangzhou, China, 310009
    - The Second Affiliated Hospital Zhejiang University
  - Hangzhou, China, 310016
    - Sir Run Shaw Hospital School of Medicine Zhejiang University
  - Harbin, China, 150000
    - Harbin Medical University Cancer Hospital
  - Hefei, China, 230022
    - The First Affiliated Hospital of Anhui Medical University
  - Hefei, China, 230601
    - The Second Affiliated Hospital of Anhui Medical University
  - Nanjing, China, 210009
    - Jiangsu Cancer Hospital
  - Nanjing, China, 210002
    - The 81 Hospital of the Chinese Peoples Liberation Army
  - Qingdao, China, 266061
    - The Affiliated Hospital of Qingdao University
  - Shanghai, China, 200032
    - Fudan University Shanghai Cancer Center
  - Shanghai, China, 200040
    - Huashan Hospital
  - Shanghai, China, 200120
    - Ren Ji Hospital Shanghai Jiaotong University School of Medicine
  - Shanghai, China, 200123
    - East Hospital of Tongji University
  - Suzhou, China, 215006
    - The First Affiliated Hospital of Soochow University
  - Tianjin, China, 300060
    - Tianjin Medical University Cancer Institute & Hospital
  - Xian, China, 710061
    - The First Affiliated Hospital of Xian Jiao Tong University
  - Yinchuan, China, 750004
    - General Hospital of Ningxia Medical University
  - Zhengzhou, China, 450008
    - Henan Cancer Hospital
Czechia
- - Benešov, Czechia, 25601
    - Onkologické oddělení
  - Brno, Czechia, 62500
    - Fakultni nemocnice Brno Interni hematoonkologicka klinika
  - Hradec Kralove, Czechia, 50005
    - Fakultni Nemocnice Hradec Kralove
  - Olomouc, Czechia, 77906
    - University Hospital Olomouc
  - Zlín, Czechia, 762 75
    - Onkologické oddělení
France
- - Amiens, France, 80054
    - Hôpital Sud - CHU Amiens Picardie
  - Chambray-lès-Tours, France, 37170
    - Hôpital Trousseau, CHRU de Tours
  - Lyon Cedex 03, France, 69437
    - Hopital Edourard Herriot
  - Nantes Cedex 1, France, 44093
    - CHU-Hôtel Dieu
  - Nice, France, 06100
    - Centre Antoine Lacassagne
  - Paris, France, 75015
    - Hopital Europeen Georges Pompidou
  - Poitiers, France, 86021
    - Poitiers university hospital
  - Rennes, France, 35042
    - Centre Eugene Marquis
  - Strasbourg, France, 67091
    - Hopital Civil de strasbourg
  - Strasbourg, France, 67000
    - Clinique Saint Anne
  - Vandœuvre-lès-Nancy, France, 54519
    - Institute de Cancérologie de Lorraine
Germany
- - Amberg, Germany, 92224
    - Gesundheitszentrum St. Marien GmbH
  - Bonn, Germany, 53127
    - University Hospital Bonn
  - Chemnitz, Germany, 09116
    - Klinikum Chemnitz
  - Frankfurt am main, Germany, 60488
    - Krankenhaus Nordwest
  - Hannover, Germany, 30625
    - Medizinische Hochschule
  - Heilbronn, Germany, 74078
    - SLK-Kliniken Heilbronn GmbH
  - Mannheim, Germany, 68167
    - Universitätsmedizin Mannheim
  - München, Germany, 81925
    - Klinikum Bogenhausen
  - Oldenburg, Germany, 26133
    - Klinikum Oldenburg AöR - UK für Innere Medizin
Italy
- - Brescia, Italy, 25124
    - Fondazione Poliambulanza
  - Candiolo, Italy, 10060
    - Istituto Ricerca e la Cura del Cancro (IRCC)
  - Catanzaro, Italy, 88200
    - AOU Mater Domini
  - Faenza, Italy, 48018
    - Ospedale Degli Infermi
  - Feltre, Italy, 32032
    - Santa Maria de Prato Hospital
  - Meldola, Italy, 47014
    - IRCCS - Studio e la Cura dei Tumori
  - Milano, Italy, 20132
    - IRCCS Ospedale San Raffaele
  - Perugia, Italy, 06132
    - AO SM Misericordia
  - Reggio Emilia, Italy, 42123
    - IRCCS Azienda Ospedaliera S.Maria Nuova
  - Rimini, Italy, 47923
    - Ospedale Degli Infermi
  - Torino, Italy, 10126
    - Dermatological Hospital San Lazzaro
  - Varese, Italy, 21100
    - ASST Settelaghi
Japan
- - Kyoto, Japan, 606-8507
    - Kyoto University Hospital
  - Osaka, Japan, 541-8567
    - Osaka International Cancer Institute
  - Saitama, Japan, 362-0806
    - Saitama Cancer Center
  - Shizuoka, Japan, 411-8777
    - Shizuoka Cancer Center
- Aichi
  - Nagoya, Aichi, Japan, 464-8681
    - Aichi Cancer Center Hospital
- Ehime
  - Matsuyama, Ehime, Japan, 791-0280
    - Shikoku Cancer Center
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8648
    - Hokkaido University Hospital
- Kanagawa
  - Yokohama, Kanagawa, Japan, 241-8515
    - Kanagawa Cancer Center
- Tochigi
  - Utsunomiya, Tochigi, Japan, 320-0834
    - Tochigi Cancer Center
- Tokyo
  - Bunkyō-Ku, Tokyo, Japan, 113-8655
    - University of Tokyo Hospital
  - Chuo-ku, Tokyo, Japan, 104-0045
    - National Cancer Center Hospital
  - Koto-Ku, Tokyo, Japan, 135-8550
    - The Cancer Institute Hospital of Jfcr
  - Mitaka, Tokyo, Japan, 181-8611
    - Kyorin University Hopsital
Korea, Republic of
- - Gyeonggi-do, Korea, Republic of, 13620
    - Seoul National University Bundang Hospital
  - Jeongnam, Korea, Republic of, 58128
    - Chonnam National University Hwasun Hospital
  - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 03722
    - Severance Hospital
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center
  - Seoul, Korea, Republic of, 08308
    - Korea University Guro Hospital
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 06591
    - Seoul st. mary's hospital
Netherlands
- - Leeuwarden, Netherlands, 8934 AD
    - Medisch Centrum Leeuwarden (MCL)
  - Sittard, Netherlands, 6162 BG
    - Zuyderland Medical Center
  - Utrecht, Netherlands, 3584 CX
    - University Medical Center Utrecht
  - Zwolle, Netherlands, 8025 AB
    - Isala Ziekenhuis
Poland
- - Gdańsk, Poland, 80-952
    - Uniwersyteckie Centrum Kliniczne
  - Gliwice, Poland, 44-101
    - Centrum Onkologii-Instytut im.M.Sklodowskiej-Curie
  - Konin, Poland, 62-500
    - Przychodnia Lekarska KOMED
  - Lublin, Poland, 20-090
    - Centrum Onkologii Ziemi Lubelskiej
  - Lublin, Poland, 20-081
    - Klinika Chirurgii Onkologicznej
  - Poznań, Poland, 44-400
    - Samodzielny Publiczny Szpital Kliniczny
  - Toruń, Poland, 87-100
    - Wojewodzki Szpital Zespolony
Portugal
- - Lisboa, Portugal, 1500-650
    - Hospital da Luz
  - Lisboa, Portugal, 1400-038
    - Fundação Champalimaud
  - Lisbon, Portugal, 1649-035
    - Centro Hospitalar Lisboa Norte
  - Porto, Portugal, 4099-001
    - Centro Hospitalar do Porto, E.P.E
  - Porto, Portugal, 4200-072
    - IPO Porto Francisco Gentil, E.P.E.
  - Santa Maria Da Feira, Portugal, 4520-211
    - Centro Hospitalar Entre Douro e Vouga
Russian Federation
- - Arkhangel'sk, Russian Federation, 163046
    - Arkhangelsk Regional Clinical Oncology Dispensary
  - Cheboksary, Russian Federation, 428020
    - Republican Clinical Oncology Dispensary
  - Chelyabinsk, Russian Federation, 454087
    - LLC Evimed
  - Chelyabinsk, Russian Federation, 454091
    - Railway Clinical Hospital on station Chelyabinsk
  - Kazan, Russian Federation, 420029
    - Republic Clinical Oncology Dispensary
  - Moscow, Russian Federation, 115478
    - N.N. Blokhin Russian Cancer Research Center
  - Nizhny Novgorod, Russian Federation, 603006
    - Privolzhsk District Medical Center
  - Omsk, Russian Federation, 644013
    - Budgetary Healthcare Institution of Omsk Region
  - Orenburg, Russian Federation, 460021
    - Orenburg Regional Clinical Oncology Dispensary
  - Pyatigorsk, Russian Federation, 357502
    - Pyatigorsk Oncology Dispensary
  - Saint Petersburg, Russian Federation, 198255
    - City Clinical Oncology Dispensary
  - Saint Petersburg, Russian Federation, 197022
    - St.Petersburg Medical Universitet n.a. I.P. Pavlov
  - Saint Petersburg, Russian Federation, 197758
    - FSBI "Russian Research Centre of Radiology and Surgical Technologies"
  - Samara, Russian Federation, 443011
    - Multi-type clinic 'REAVIZ'
  - Saransk, Russian Federation, 430032
    - National Research Mordovia State University
- Kursk
  - Kislino, Kursk, Russian Federation, 305524
    - Kursk Regional Clinical Oncology Dispensary
Singapore
- - Singapore, Singapore, 169610
    - National Cancer Centre Singapore
  - Singapore, Singapore, 308433
    - Tan Tock Seng Hospital
Spain
- - Barcelona, Spain, 08036
    - Hospital Clínico y Provincial de Barcelona
  - Barcelona, Spain, 08035
    - Hospital Vall d´hebron
  - Barcelona, Spain, 08916
    - Hospital Universitario Germans Trias i Pujol
  - Barcelona, Spain, 08916
    - (ICO) Hospital Duran i Reynals
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz
  - Madrid, Spain, 28007
    - Hospital Universitario Gregorio Marañón
  - Madrid, Spain, 28050
    - Centro Integral Oncologico Clara Campal
  - Madrid, Spain, 28220
    - Hospital Universitario Puerta de Hierro
  - Madrid, Spain, 28922
    - Hospital Universitario Fundacion Alcorcon
  - Málaga, Spain, 29010
    - Hospital Regional Universitario de Málaga
Taiwan
- - Kaohsiung City, Taiwan, 833
    - Kaohsiung Chang Gung Memorial Hospital
  - Taichung, Taiwan, 404
    - China Medical University Hospital
  - Taipei City, Taiwan, 11217
    - Taipei Veterans General Hospital
  - Taoyuan, Taiwan, 333
    - Linkou Chang Gung Memorial Hospital
Ukraine
- - Kharkiv, Ukraine, 61005
    - Zaytsev Institute General and Urgent Surgery of National Academy Medical Science of Ukraine
  - Kyiv, Ukraine, 03022
    - National Institute of Cancer
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - UAB Comprehensive Cancer Center
  - Huntsville, Alabama, United States, 35805
    - Clearview Cancer Institute (CCI)
- Arizona
  - Gilbert, Arizona, United States, 85234
    - Banner MD Anderson Cancer Center
  - Phoenix, Arizona, United States, 85054
    - Mayo Clinic
- Arkansas
  - Fayetteville, Arkansas, United States, 72703
    - Highlands Oncology Group
- California
  - Bakersfield, California, United States, 93309
    - Comprehensive Blood and Cancer Center
  - Los Angeles, California, United States, 90033
    - University of Southern California
  - Los Angeles, California, United States, 90017
    - Los Angeles Hematology Oncology Medical Group
  - Orange, California, United States, 92868
    - St. Joseph Hospital of Orange
  - Redondo Beach, California, United States, 90277
    - Torrance Health Association DBA Torrance Memorial
  - Sacramento, California, United States, 95817
    - UC Davis
  - Santa Monica, California, United States, 90404-2125
    - UCLA Medical Center Santa Monica Hematology And Oncology
  - Vallejo, California, United States, 94589-2441
    - Kaiser Permanente - Vallejo Medical Center
- Connecticut
  - Norwalk, Connecticut, United States, 06850-3852
    - Norwalk Hospital The C Anthony and Jean Whittingham Cancer Center
  - Norwalk, Connecticut, United States, 06850-3852
    - The C Anthony and Jean Whittingham Cancer Center
- Delaware
  - Newark, Delaware, United States, 19713
    - Helen F. Graham Cancer Center
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Georgetown University Medical Center (GUMC)
- Florida
  - Fort Myers, Florida, United States, 33916
    - Florida Cancer Specialists & Research Institute
  - Hollywood, Florida, United States, 33021
    - Memorial Regional Hospital
  - Jacksonville, Florida, United States, 32256
    - Cancer Specialists of North Florida
  - Jacksonville, Florida, United States, 32224
    - Mayo Clinic Cancer Center
  - Miami, Florida, United States, 33136
    - Sylvester Comprehensive Cancer Center
  - Miami Beach, Florida, United States, 33140
    - Mount Sinai Medical Center
  - Orlando, Florida, United States, 32806
    - UF Health Cancer Center - Orlando Health
  - Saint Petersburg, Florida, United States, 33705
    - Florida Cancer Specialists NORTH
  - Wellington, Florida, United States, 33414
    - Florida Cancer Specialists East Region
- Georgia
  - Athens, Georgia, United States, 30607
    - University Cancer & Blood Center
  - Atlanta, Georgia, United States, 30322
    - Winship Cancer Institute of Emory University
  - Columbus, Georgia, United States, 31904
    - Columbus Regional Research Institute
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Health System
- Illinois
  - Evanston, Illinois, United States, 60201
    - NorthShore University Health Systems
  - Harvey, Illinois, United States, 60426
    - Ingalls Cancer Research Center
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center CCOP
  - Warrenville, Illinois, United States, 60555-3269
    - Northwestern Medicine Regional Medical Group
- Indiana
  - Fort Wayne, Indiana, United States, 46845
    - Parkview Physician Group (PPG)
  - Indianapolis, Indiana, United States, 46202
    - Indiana University - Melvin and Bren Simon Cancer
- Kansas
  - Topeka, Kansas, United States, 66606
    - Cotton O'Neil Cancer Center
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Norton Cancer Institute
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Louisiana Hematology Oncology Associates (LHOA)
- Maine
  - Scarborough, Maine, United States, 04074-7171
    - Maine Center for Cancer Medicine - Scarborough
- Maryland
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center
- Massachusetts
  - Worcester, Massachusetts, United States, 01655
    - UMASS Memorial Medical Center
- Michigan
  - Detroit, Michigan, United States, 48334
    - Barbara Ann Karmanos Cancer Institute
- Minnesota
  - Duluth, Minnesota, United States, 55805
    - St. Luke's Hospital of Duluth
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro MN Clinical Oncology Research Consortium
- Mississippi
  - Jackson, Mississippi, United States, 39202
    - Jackson Oncology Associates
- Missouri
  - Columbia, Missouri, United States, 65212
    - University of Missouri - Ellis Fischel Cancer Cent
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Hospital
  - Kansas City, Missouri, United States, 64132
    - HCA Midwest Division (Kansas City)
  - Saint Louis, Missouri, United States, 63110-1032
    - Washington University School of Medicine
  - Springfield, Missouri, United States, 65804
    - Mercy Clinic - Cancer & Hematology
- Montana
  - Billings, Montana, United States, 59102
    - St. Vincent Frontier Cancer Center
- Nebraska
  - Omaha, Nebraska, United States, 68114
    - Nebraska Methodist Hospital
- New Jersey
  - Englewood, New Jersey, United States, 07631
    - Englewood Hospital and Medical Center
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - UNM Cancer Research and Treatment Center
  - Farmington, New Mexico, United States, 87401
    - San Juan Oncology Associates
- New York
  - Bronx, New York, United States, 10467
    - Montefiore Cancer Center
  - Cooperstown, New York, United States, 13326
    - Basset Medical Center
  - East Setauket, New York, United States, 11733
    - North Shore Hematology Oncology Associates PC
  - East Syracuse, New York, United States, 13057
    - Hematology Oncology Associates of Central New York
  - Lake Success, New York, United States, 11042
    - Clinical Research Alliance
  - New York, New York, United States, 10021
    - Weill Cornell Medicine/ NewYork-Presbyterian
  - Rochester, New York, United States, 14642
    - University of Rochester Medical Center
  - Stony Brook, New York, United States, 11794
    - Stony Brook University
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - UNC Chapel Hill / Lineberger Comprehensive Cancer
  - Goldsboro, North Carolina, United States, 27534
    - Southeastern Medical Oncology Center
  - Greensboro, North Carolina, United States, 27403
    - Cone Health Cancer Center
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth Outpatient Cancer Center
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest Baptist Hospital
- Ohio
  - Canton, Ohio, United States, 44718
    - Gabrail Cancer Center (GCC) - Canton Facility
  - Toledo, Ohio, United States, 43623-3536
    - Toledo Clinic Cancer Centers
- Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - Cancer Center of Southwest Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120
    - Mercy Clinic Oncology and Hematology - McAuley
- Oregon
  - Hillsboro, Oregon, United States, 97124-5806
    - Kaiser Permanente - Westside Medical Office
  - Portland, Oregon, United States, 97120
    - OHSU Knight Cancer Institute
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Penn State Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, United States, 19111-2434
    - Fox Chase Cancer Center (FCCC) - Philadelphia
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny General Hospital
- South Carolina
  - Charleston, South Carolina, United States, 29414
    - Charleston Hematology Oncology Associates
  - Charleston, South Carolina, United States, 29425-8900
    - Medical University of South Carolina (MUSC)
  - Greenville, South Carolina, United States, 29615
    - GHS Cancer Institute
  - Greenville, South Carolina, United States, 29607-5253
    - Saint Francis Cancer Center
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Medical Group
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Tennessee Oncology Chattanooga
  - Knoxville, Tennessee, United States, 37920
    - University of Tennessee Medical Center
  - Nashville, Tennessee, United States, 37203-1625
    - SCRI - Tennessee Oncology
- Texas
  - Fort Worth, Texas, United States, 76104
    - The Center for Cancer and Blood Disorders
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine
- Virginia
  - Midlothian, Virginia, United States, 23114-3203
    - Bon Secours Cancer Institute Medical Oncology
  - Richmond, Virginia, United States, 23226
    - Virginia Cancer Institute
  - Roanoke, Virginia, United States, 24014
    - Oncology and Hematology Associates of Southwest Virginia
- Washington
  - Everett, Washington, United States, 98201
    - The Everett Clinic
  - Tacoma, Washington, United States, 98405
    - Multicare Institute for Research and Innovation
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University Mary Babb Randolph Cancer Center (MBRCC)
- Wisconsin
  - Green Bay, Wisconsin, United States, 54301
    - HSHS St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology, Ltd. - West Green Bay
  - Milwaukee, Wisconsin, United States, 53215-4330
    - Aurora St. Luke's Medical Center - Vince Lombardi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable International Conference on Harmonization (ICH) guidelines and local and regulatory requirements prior to the performance of any study specific procedure.
Must have histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma (PDAC) that is metastatic. The definitive diagnosis of metastatic PDAC will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.
Must not have previously received chemotherapy or any investigational agent for the treatment of PDAC. A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed for as long as last dose was administered > 6 months prior to randomization and no lingering toxicities are present.
Nab-paclitaxel with gemcitabine therapy is appropriate for the patient and recommended by the Investigator.
Patient has one or more metastatic tumors evaluable by CT scan with contrast (or MRI, if patient is allergic to CT contrast media) per RECIST 1.1. Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease must be performed within 14 days prior to randomization. Qualifying scans performed as part of standard of care prior to patient signature of the study informed consent will be acceptable as baseline scanning as long as scanning is performed < 14 days prior to randomization.
Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, assessed within 14 days prior to randomization. Two observers qualified to perform assessment of the performance status will be required to perform this assessment. If discrepant, the one with the most deteriorated performance status will be considered true.
Must have life-expectancy of > 12 weeks.
Must be ≥ 18 years of age. Due to increased risk of sepsis in patients >80 years old, candidate patients in this age group should be thoroughly evaluated prior to study randomization to ensure they are fit to receive chemotherapy. In addition to all of the inclusion/exclusion criteria listed, clinical judgment should be used regarding patients' susceptibility to infection (including but not limited to presence of ascites or diabetes mellitus increasing risk of infection). Furthermore, the expected stability of their performance status while receiving repeat weekly chemotherapy cycles should be given special attention. Patients in this age group should not be randomized on the study should there be any hesitation on any of these considerations.
For male or female patients of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days after the final dose of nab-paclitaxel and gemcitabine or for 30 days for female patients and for 90 days for male patients, after the final napabucasin dose if nab-paclitaxel and gemcitabine were not administered.
Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization.
Patient has adequate biological parameters as demonstrated by the following blood counts at baseline (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization):
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.
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.
Patient not on anticoagulation has acceptable coagulation studies (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) below or within normal limits (+15%).
Patients on anticoagulation must have coagulation values within the therapeutic range appropriate for the anti-coagulation indication.
Patient has no clinically significant abnormalities on urinalysis results (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization).
Patient must have adequate nutritional status with Body Mass Index (BMI) > 18 kg/m^2 and body weight of > 40 kg with serum albumin > 3 g/dL.
Baseline laboratory evaluations must be done within 14 days prior to randomization and some must be repeated < 72 hours prior to randomization.
Patients requiring biliary stent placement must have biliary stent placed > 7 days prior to screening.
Pain symptoms should be stable (of tolerable Grade 2 or less).
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.
Patient must consent to provision of a sample of blood in order that the specific correlative marker assays (Correlative Studies) 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 for patients randomized to Arm 1. Patients randomized to Arm 2 must begin protocol treatment within 7 calendar days of 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.

Exclusion Criteria:

Patients with no evidence of metastatic disease as well as patients with a local recurrence following surgical resection of primary lesion.
Patient has experienced a decline in ECOG performance status between Baseline visit and within 72 hours prior to randomization.
Patient has a > 20% decrease in serum albumin level between Baseline visit and within 72 hours prior to randomization.
Patient has a > 10% decrease in weight between Baseline visit and within 72 hours prior to randomization.
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.
Major surgery within 4 weeks prior to randomization.
Any known brain or leptomeningeal metastases are excluded, even if treated.
Patients with clinically significant ascites or pleural effusions.
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.
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).
Unable or unwilling to swallow napabucasin capsules daily.
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.
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.
Neurosensory neuropathy > grade 2 at baseline.
Uncontrolled chronic diarrhea > grade 2 at baseline.
Patients being treated with Warfarin.
Patients with active, uncontrolled bacterial, viral or fungal infection(s) requiring systemic therapy
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.
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, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Napabucasin Napabucasin will be administered orally, twice daily, with doses separated by approximately 12 hours. Other Names: BBI-608 BBI608 BB608 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. Other Names: Abraxane 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. Other Names: Gemzar
Active Comparator: 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.	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. Other Names: Abraxane 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. Other Names: Gemzar

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: Napabucasin

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

Other Names:

BBI-608
BBI608
BB608

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.

Other Names:

Abraxane

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.

Other Names:

Gemzar

Active Comparator: 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.

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.

Other Names:

Abraxane

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.

Other Names:

Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time Frame: From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.	To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma.	From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival Time Frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months	To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.	From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
Disease Control Rate Time Frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months	To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma. DCR is defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.	From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
Overall Response Rate Time Frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months	To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma. ORR is evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1).	From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
Number of Patients With Adverse Events Time Frame: Every 1-2 weeks from date of screening until protocol treatment discontinuation. Following permanent protocol treatment discontinuation, every 8 weeks, starting with the 4 week post-protocol treatment discontinuation visit, up to 36 months.	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.	Every 1-2 weeks from date of screening until protocol treatment discontinuation. Following permanent protocol treatment discontinuation, every 8 weeks, starting with the 4 week post-protocol treatment discontinuation visit, up to 36 months.
Mean Change From Baseline for Global Quality of Life (QoL) at 8 Weeks. Time Frame: 8 weeks	QoL will be measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) in patients with metastatic pancreatic ductal adenocarcinoma with napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine. EORTQ QLC-C30 is a questionnaire used to assess the overall quality of life in cancer patients - 28 questions use a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher overall score = better quality of life.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival in Biomarker Positive Patients Time Frame: From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.	To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.	From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.
Progression Free Survival in Biomarker Positive Patients Time Frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months	To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.	From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
Disease Control Rate in Biomarker Positive Patients Time Frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months	To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. DCR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.	From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
Overall Response Rate in Biomarker Positive Patients Time Frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months	To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. ORR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.	From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sumitomo Pharma America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 13, 2016

First Posted (Estimated)

December 15, 2016

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

CanStem111P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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A Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Carcinoma, Pancreatic Ductal

Clinical Trials on Napabucasin

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