AzTrials
AzTrials

Carcinoma, Pancreatic DuctalPhase 3CanStem111PNCT02993731

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

A Phase 3 study testing Napabucasin, Nab-paclitaxel and Gemcitabine in people with Carcinoma, Pancreatic Ductal, run by Sumitomo Pharma America, Inc. at 267 sites in 20 countries.

Completed

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

Official record
Search all trials

Trial summary

This is 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Pancreatic Ductal
What is being tested?
Napabucasin, Nab-paclitaxel and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,134 participants
Where
267 sitesin 20 countries
Study dates
Dec 2016to Mar 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable 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.
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  • 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):
  • Absolute neutrophil count (ANC) > 1.5 x 10^9/L
  • 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.
  • 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):
  • AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional upper limit of normal (ULN) [≤ 5 × ULN in presence of liver metastases]
  • 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.
  • 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.

Who cannot join

  • 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.
  • Patients receiving immunotherapy for non-cancer related treatment within < 4 weeks of first planned dose of study treatment will be excluded.
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  • 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.
  • 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).
  • 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.
  • 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.
  • 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 randomization.
  • Patients with clinically significant abnormalities on urinalysis at < 14 days prior to randomization.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization.
  • Ongoing serious, non-healing wound, ulcer, or bone fracture.
  • Known infection with Human Immunodeficiency Virus (HIV), and/or active infection with hepatitis B, or hepatitis C.
  • History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
  • History of hemolytic-uremic syndrome.
  • History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).
  • 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.

Trial locations and contacts

267 sites in 20 countries.

267 sites in 20 countries

United States99 sites

  • UNM Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131

  • University Cancer & Blood Center

    Athens, Georgia, 30607

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Louisiana Hematology Oncology Associates (LHOA)

    Baton Rouge, Louisiana, 70809

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Saint Alphonsus Health System

    Boise, Idaho, 83706

  • Gabrail Cancer Center (GCC) - Canton Facility

    Canton, Ohio, 44718

  • UNC Chapel Hill / Lineberger Comprehensive Cancer

    Chapel Hill, North Carolina, 27599

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29414

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425-8900

  • Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404

  • University of Missouri - Ellis Fischel Cancer Cent

    Columbia, Missouri, 65212

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Basset Medical Center

    Cooperstown, New York, 13326

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48334

  • St. Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • North Shore Hematology Oncology Associates PC

    East Setauket, New York, 11733

  • Hematology Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • NorthShore University Health Systems

    Evanston, Illinois, 60201

  • The Everett Clinic

    Everett, Washington, 98201

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida, 33916

  • Parkview Physician Group (PPG)

    Fort Wayne, Indiana, 46845

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • HSHS St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology, Ltd. - West Green Bay

    Green Bay, Wisconsin, 54303

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607-5253

  • GHS Cancer Institute

    Greenville, South Carolina, 29615

  • Ingalls Cancer Research Center

    Harvey, Illinois, 60426

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Kaiser Permanente - Westside Medical Office

    Hillsboro, Oregon, 97124-5806

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Clearview Cancer Institute (CCI)

    Huntsville, Alabama, 35805

  • Indiana University - Melvin and Bren Simon Cancer

    Indianapolis, Indiana, 46202

  • Jackson Oncology Associates

    Jackson, Mississippi, 39202

  • Mayo Clinic Cancer Center

    Jacksonville, Florida, 32224

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • HCA Midwest Division (Kansas City)

    Kansas City, Missouri, 64132

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Clinical Research Alliance

    Lake Success, New York, 11042

  • Cancer Center of Southwest Oklahoma

    Lawton, Oklahoma, 73505

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90017

  • University of Southern California

    Los Angeles, California, 90033

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Bon Secours Cancer Institute Medical Oncology

    Midlothian, Virginia, 23114-3203

  • Aurora St. Luke's Medical Center - Vince Lombardi

    Milwaukee, Wisconsin, 53215-4330

  • West Virginia University Mary Babb Randolph Cancer Center (MBRCC)

    Morgantown, West Virginia, 26506

  • SCRI - Tennessee Oncology

    Nashville, Tennessee, 37203-1625

  • Weill Cornell Medicine/ NewYork-Presbyterian

    New York, New York, 10021

  • Helen F. Graham Cancer Center

    Newark, Delaware, 19713

  • Norwalk Hospital The C Anthony and Jean Whittingham Cancer Center

    Norwalk, Connecticut, 06850-3852

  • The C Anthony and Jean Whittingham Cancer Center

    Norwalk, Connecticut, 06850-3852

  • Mercy Clinic Oncology and Hematology - McAuley

    Oklahoma City, Oklahoma, 73120

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • St. Joseph Hospital of Orange

    Orange, California, 92868

  • UF Health Cancer Center - Orlando Health

    Orlando, Florida, 32806

  • Fox Chase Cancer Center (FCCC) - Philadelphia

    Philadelphia, Pennsylvania, 19111-2434

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97120

  • Torrance Health Association DBA Torrance Memorial

    Redondo Beach, California, 90277

  • Virginia Cancer Institute

    Richmond, Virginia, 23226

  • Oncology and Hematology Associates of Southwest Virginia

    Roanoke, Virginia, 24014

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • UC Davis

    Sacramento, California, 95817

  • Metro MN Clinical Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • UCLA Medical Center Santa Monica Hematology And Oncology

    Santa Monica, California, 90404-2125

  • Maine Center for Cancer Medicine - Scarborough

    Scarborough, Maine, 04074-7171

  • Avera Medical Group

    Sioux Falls, South Dakota, 57105

  • Mercy Clinic - Cancer & Hematology

    Springfield, Missouri, 65804

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1032

  • Florida Cancer Specialists North

    St. Petersburg, Florida, 33705

  • Stony Brook University

    Stony Brook, New York, 11794

  • MultiCare Institute for Research and Innovation

    Tacoma, Washington, 98405

  • Montefiore Cancer Center

    The Bronx, New York, 10467

  • Toledo Clinic Cancer Centers

    Toledo, Ohio, 43623-3536

  • Cotton O'Neil Cancer Center

    Topeka, Kansas, 66606

  • Carle Cancer Center CCOP

    Urbana, Illinois, 61801

  • Kaiser Permanente - Vallejo Medical Center

    Vallejo, California, 94589-2441

  • Northwestern Medicine Regional Medical Group

    Warrenville, Illinois, 60555-3269

  • Georgetown University Medical Center (GUMC)

    Washington D.C., District of Columbia, 20007

  • Florida Cancer Specialists East Region

    Wellington, Florida, 33414

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Wake Forest Baptist Hospital

    Winston-Salem, North Carolina, 27157

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

China26 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Chinese PLA General Hospital

    Beijing, 100853

  • Jilin Cancer Hospital

    Changchun, 130021

  • The first hospital of jilin university

    Changchun, 130021

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • Cancer Center of Guangzhou Medical University

    Guangzhou, 510095

  • Guangdong General Hospital

    Guangzhou, 510180

  • The First Affiliated Hospital Zhejiang University

    Hangzhou, 310003

  • The Second Affiliated Hospital Zhejiang University

    Hangzhou, 310009

  • Sir Run Shaw Hospital School of Medicine Zhejiang University

    Hangzhou, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, 150000

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, 230601

  • The 81 Hospital of the Chinese Peoples Liberation Army

    Nanjing, 210002

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266061

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Huashan Hospital

    Shanghai, 200040

  • Ren Ji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200120

  • East Hospital of Tongji University

    Shanghai, 200123

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060

  • The First Affiliated Hospital of Xian Jiao Tong University

    Xi'an, 710061

  • General Hospital of Ningxia Medical University

    Yinchuan, 750004

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Russia16 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, 163046

  • Republican Clinical Oncology Dispensary

    Cheboksary, 428020

  • Llc Evimed

    Chelyabinsk, 454087

  • Railway Clinical Hospital on station Chelyabinsk

    Chelyabinsk, 454091

  • Republic Clinical Oncology Dispensary

    Kazan', 420029

  • Kursk Regional Clinical Oncology Dispensary

    Kislino, Kursk Oblast, 305524

  • N.N. Blokhin Russian Cancer Research Center

    Moscow, 115478

  • Privolzhsk District Medical Center

    Nizhny Novgorod, 603006

  • Budgetary Healthcare Institution of Omsk Region

    Omsk, 644013

  • Orenburg Regional Clinical Oncology Dispensary

    Orenburg, 460021

  • Pyatigorsk Oncology Dispensary

    Pyatigorsk, 357502

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

    Saint Petersburg, 197022

  • FSBI "Russian Research Centre of Radiology and Surgical Technologies"

    Saint Petersburg, 197758

  • City Clinical Oncology Dispensary

    Saint Petersburg, 198255

  • Multi-type clinic 'REAVIZ'

    Samara, 443011

  • National Research Mordovia State University

    Saransk, 430032

Other trials in Russia

Australia14 sites

  • Blacktown Cancer and Haematology Centre

    Blacktown, 2148

  • Border Medical Oncology

    East Albury, New South Wales, 2109

  • Border Medical Oncology

    East Albury, 2640

  • The Austin Hospital

    Heidelberg, 3084

  • Cabrini Hospital

    Malvern, Victoria, 3144

  • Cabrini Hospital

    Malvern, 3144

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

  • Prince of Wales Private Hospital

    Randwick, 2031

  • ICON Cancer Care

    South Brisbane, South Australia, 4101

  • ICON Cancer Care

    South Brisbane, 4101

  • Macquarie University Hospital

    Sydney, New South Wales, 2109

  • Macquarie University Hospital

    Sydney, 2109

  • The Tweed Hospital

    Tweed Heads, 2485

  • Sydney Adventist Hospital

    Wahroonga, 2076

Other trials in Australia

Japan13 sites

  • University of Tokyo Hospital

    Bunkyō-Ku, Tokyo, 113-8655

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • The Cancer Institute Hospital Of JFCR

    Koto-Ku, Tokyo, 135-8550

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Kyorin University Hopsital

    Mitaka, Tokyo, 181-8611

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Saitama Cancer Center

    Saitama, 362-0806

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • Tochigi Cancer Center

    Utsunomiya, Tochigi, 320-0834

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Italy12 sites

  • Fondazione Poliambulanza

    Brescia, 25124

  • Istituto Ricerca e la Cura del Cancro (IRCC)

    Candiolo, 10060

  • AOU Mater Domini

    Catanzaro, 88200

  • Ospedale degli Infermi

    Faenza, 48018

  • Santa Maria de Prato Hospital

    Feltre, 32032

  • IRCCS - Studio e la Cura dei Tumori

    Meldola, 47014

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • AO SM Misericordia

    Perugia, 06132

  • IRCCS Azienda Ospedaliera S.Maria Nuova

    Reggio Emilia, 42123

  • Ospedale degli Infermi

    Rimini, 47923

  • Dermatological Hospital San Lazzaro

    Torino, 10126

  • ASST Settelaghi

    Varese, 21100

Other trials in Italy

France11 sites

  • Hôpital Sud - CHU Amiens Picardie

    Amiens, 80054

  • Hôpital Trousseau, CHRU de Tours

    Chambray-lès-Tours, 37170

  • Hopital Edourard Herriot

    Lyon, 69437

  • CHU-Hôtel Dieu

    Nantes, 44093

  • Centre Antoine Lacassagne

    Nice, 06100

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Poitiers University Hospital

    Poitiers, 86021

  • Centre Eugene Marquis

    Rennes, 35042

  • Clinique Saint Anne

    Strasbourg, 67000

  • Hopital Civil de strasbourg

    Strasbourg, 67091

  • Institute de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

Other trials in France

Spain11 sites

  • Hospital Vall d´Hebron

    Barcelona, 08035

  • Hospital Clínico y Provincial de Barcelona

    Barcelona, 08036

  • (ICO) Hospital Duran i Reynals

    Barcelona, 08916

  • Hospital Universitario Germans Trias i Pujol

    Barcelona, 08916

  • Hospital Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro

    Madrid, 28220

  • Hospital Universitario Fundacion Alcorcon

    Madrid, 28922

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

Other trials in Spain

Germany9 sites

  • Gesundheitszentrum St. Marien GmbH

    Amberg, 92224

  • University Hospital Bonn

    Bonn, 53127

  • Klinikum Chemnitz

    Chemnitz, 09116

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488

  • Medizinische Hochschule

    Hanover, 30625

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

  • Universitätsmedizin Mannheim

    Mannheim, 68167

  • Klinikum Bogenhausen

    München, 81925

  • Klinikum Oldenburg AöR - UK für Innere Medizin

    Oldenburg, 26133

Other trials in Germany

South Korea8 sites

  • Seoul national University Bundang Hospital

    Gyeonggi-do, 13620

  • Chonnam National University Hwasun Hospital

    Jeongnam, 58128

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Seoul St. Mary's Hospital

    Seoul, 06591

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Belgium7 sites

  • ULB Erasme

    Brussels, 13-1070

  • Antwerp University Hospital

    Edegem, B-2650

  • UZ Ghent

    Ghent, 9000

  • UZ Brussel

    Jette, 1070

  • UZ Leuven

    Leuven, 3000

  • CHU de Liege

    Liège, 4000

  • CHU Dinant Godinne

    Yvoir, 5530

Other trials in Belgium

Poland7 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Centrum Onkologii-Instytut im.M.Sklodowskiej-Curie

    Gliwice, 44-101

  • Przychodnia Lekarska KOMED

    Konin, 62-500

  • Klinika Chirurgii Onkologicznej

    Lublin, 20-081

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, 20-090

  • Samodzielny Publiczny Szpital Kliniczny

    Poznan, 44-400

  • Wojewodzki Szpital Zespolony

    Torun, 87-100

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Canada6 sites

  • Cross Cancer Institute

    Edmonton, T6G 1Z2

  • Dr. Everett Chalmers Regional Hospital

    Fredericton, New Brunswick, E3B 5N5

  • The Atlantic Clinical Cancer Research Unit (ACCRU)

    Halifax, Nova Scotia, B3H 1C2

  • Centre Hospitalier de St. Mary

    Pointe-Claire, Quebec, H9R 2Y2

  • University of Toronto - St. Michael's Hospital

    Toronto, M5B 1W8

  • Ciusssmcq

    Trois-Rivières, Quebec, G8Z 3R9

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Portugal6 sites

  • Fundação Champalimaud

    Lisbon, 1400-038

  • Hospital da Luz

    Lisbon, 1500-650

  • Centro Hospitalar Lisboa Norte

    Lisbon, 1649-035

  • Centro Hospitalar do Porto, E.P.E

    Porto, 4099-001

  • IPO Porto Francisco Gentil, E.P.E.

    Porto, 4200-072

  • Centro Hospitalar Entre Douro e Vouga

    Santa Maria da Feira, 4520-211

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Austria5 sites

  • LKH Universitätsklinikum Graz

    Graz, 8036

  • Landeskrankenhaus Medical University Innsbruck

    Innsbruck, 6020

  • Landeskrankenhaus Feldkirch

    Rankweil, 6830

  • Universitatsklinik far Innere Medizin III

    Salzburg, 5020

  • Medical University Vienna

    Vienna, 1090

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Czechia5 sites

  • Onkologicke oddeleni

    Benešov, 25601

  • Fakultni nemocnice Brno Interni hematoonkologicka klinika

    Brno, 62500

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50005

  • University Hospital Olomouc

    Olomouc, 77906

  • Onkologické oddělení

    Zlín, 762 75

Other trials in Czechia

Netherlands4 sites

  • Medisch Centrum Leeuwarden (MCL)

    Leeuwarden, 8934 AD

  • Zuyderland Medical Center

    Sittard, 6162 BG

  • University Medical Center Utrecht

    Utrecht, 3584 CX

  • Isala Ziekenhuis

    Zwolle, 8025 AB

Other trials in Netherlands

Taiwan4 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 404

  • Taipei Veterans General Hospital

    Taipei, 11217

  • LinKou Chang Gung Memorial Hospital

    Taoyuan, 333

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Singapore2 sites

  • National Cancer Centre Singapore

    Singapore, 169610

  • Tan Tock Seng Hospital

    Singapore, 308433

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Ukraine2 sites

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

    Kharkiv, 61005

  • National Institute of Cancer

    Kyiv, 03022

Other trials in Ukraine

About this study

Official title: 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.

Being tested
Napabucasin, Nab-paclitaxel, Gemcitabine
Keywords
Neoplasms, Neoplasms by Site, Digestive System Neoplasms, Endocrine Gland Neoplasms, Pancreatic Neoplasms, Adenocarcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Digestive System Diseases, Pancreatic Diseases, Endocrine System Diseases, Albumin-Bound Paclitaxel, Gemcitabine
Medical subject headings
Carcinoma, Pancreatic Ductal, Neoplasms, Neoplasms by Site, Digestive System Neoplasms, Endocrine Gland Neoplasms, Pancreatic Neoplasms, Adenocarcinoma, Neoplasms, Glandular and Epithelial

What participants receive

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

  • NapabucasinDrug

    Also called BBI-608, BBI608, BB608

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

  • Nab-paclitaxelDrug

    Also called Abraxane

    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.

  • GemcitabineDrug

    Also called Gemzar

    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.

Study groups in NCT02993731
Study groupRoleWhat they receive
Arm 1: Napabucasin plus Nab-paclitaxel with GemcitabineExperimentalPatients 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.
Receives: Drug: Napabucasin; Drug: Nab-paclitaxel; Drug: Gemcitabine
Arm 2: Nab-paclitaxel with GemcitabineActive comparatorPatients randomized to this arm will receive weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine

What is being measured

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

  1. Overall Survival

    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.

    Measured: 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 outcomes (5)

  1. Progression Free Survival

    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.

    Measured: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months

  2. Disease Control Rate

    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.

    Measured: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months

  3. Overall Response Rate

    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).

    Measured: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months

  4. Number of Patients With Adverse Events

    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.

    Measured: 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.

  5. Mean Change From Baseline for Global Quality of Life (QoL) at 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.

    Measured: 8 weeks

Timeline

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

  1. First posted15 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionMar 2020
  4. Study completionMar 2020

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02993731
Sponsor's protocol ID
CanStem111P
Acronym
CanStem111P
Status last verified
Nov 2023
First submitted
13 Dec 2016
Last updated
15 Nov 2023
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Napabucasin, Nab-paclitaxel and Gemcitabine in people with Carcinoma, Pancreatic Ductal, run by Sumitomo Pharma America, Inc. at 267 sites in 20 countries.

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

Who may be eligible to take part?

The sponsor lists 30 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

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

Where is the study taking place?

The record lists 267 sites in United States, China, Russia, Australia, Japan and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Overall Survival (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02993731.

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

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

How often is this information updated?

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

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