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

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ClinicalTrials.gov Identifier: NCT02993731
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Biomedical, Inc

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

Condition or disease Intervention/treatment Phase
Carcinoma, Pancreatic Ductal Drug: Napabucasin Drug: Nab-paclitaxel Drug: Gemcitabine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
Study Start Date : December 2016
Estimated Primary Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: Gemzar




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 36 months ]
    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.


Secondary Outcome Measures :
  1. Overall Survival in biomarker positive patients [ Time Frame: 36 months ]
    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.

  2. Progression Free Survival [ Time Frame: 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.

  3. Progression Free Survival in biomarker positive patients [ Time Frame: 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.

  4. Overall Response Rate [ Time Frame: 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 RECIST 1.1.

  5. Disease Control Rate [ Time Frame: 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.

  6. Overall Response Rate in biomarker positive patients [ Time Frame: 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.

  7. Disease Control Rate in biomarker positive patients [ Time Frame: 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. 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.

  8. Quality of Life (QoL) [ Time Frame: 36 months ]
    QoL will be measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) in patients with metastatic pancreatic ductal adenocarcinoma with napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine.

  9. Number of Patients with Adverse Events [ Time Frame: 36 months ]
    All patients who have received at least one dose of napabucasin will be included in the safety analysis according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. The incidence of adverse events will be summarized by type of adverse event and severity.



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

Inclusion Criteria:

  1. Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable International Conference on Harmonization (ICH) guidelines and local and regulatory requirements prior to the performance of any study specific procedure.
  2. Must have histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma (PDAC) that is metastatic. The definitive diagnosis of metastatic PDAC will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.
  3. Must not have previously received chemotherapy or any investigational agent for the treatment of PDAC. A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed for as long as last dose was administered > 6 months prior to randomization and no lingering toxicities are present.
  4. Nab-paclitaxel with gemcitabine therapy is appropriate for the patient and recommended by the Investigator.
  5. Patient has one or more metastatic tumors evaluable by CT scan with contrast (or MRI, if patient is allergic to CT contrast media) per RECIST 1.1. Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease must be performed within 14 days prior to randomization. Qualifying scans performed as part of standard of care prior to patient signature of the study informed consent will be acceptable as baseline scanning as long as scanning is performed < 14 days prior to randomization.
  6. Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, assessed within 14 days prior to randomization. Two observers qualified to perform assessment of the performance status will be required to perform this assessment. If discrepant, the one with the most deteriorated performance status will be considered true.
  7. Must have life-expectancy of > 12 weeks.
  8. 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.
  9. For male or female patients of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days after the final dose of nab-paclitaxel and gemcitabine or for 30 days for female patients and for 90 days for male patients, after the final napabucasin dose if nab-paclitaxel and gemcitabine were not administered.
  10. Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization.
  11. Patient has adequate biological parameters as demonstrated by the following blood counts at baseline (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization):

    1. Absolute neutrophil count (ANC) > 1.5 x 10^9/L
    2. Platelet count > 100,000/mm^3 (100 x 10^9/L). Must not have required transfusion of platelets within 1 week of baseline platelet count assessment.
    3. Hemoglobin (HgB) > 9 g/dL. Must not have required transfusion of red blood cells within 1 week of baseline Hgb assessment.
  12. Patient has the following blood chemistry levels at baseline (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization):

    1. AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional upper limit of normal (ULN) [≤ 5 × ULN in presence of liver metastases]
    2. Total bilirubin ≤ 1.5 x institutional ULN. If total bilirubin is > ULN and < 1.5 x ULN, it must be non-rising for at least 7 days.
    3. Serum creatinine within normal limits or calculated clearance > 60 mL/min/1.73 m^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg. Using the Cockcroft-Gault formula). For patients with a Body Mass Index (BMI) > 30 kg/m^2, lean body weight should be used instead.
  13. Patient not on anticoagulation has acceptable coagulation studies (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) below or within normal limits (+15%).

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

  14. Patient has no clinically significant abnormalities on urinalysis results (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization).
  15. Patient must have adequate nutritional status with Body Mass Index (BMI) > 18 kg/m^2 and body weight of > 40 kg with serum albumin > 3 g/dL.
  16. Baseline laboratory evaluations must be done within 14 days prior to randomization and some must be repeated < 72 hours prior to randomization.
  17. Patients requiring biliary stent placement must have biliary stent placed > 7 days prior to screening.
  18. Pain symptoms should be stable (of tolerable Grade 2 or less).
  19. Only patients with available archival tumor tissue must consent to provision of, and Investigator(s) must confirm access to and agree to submit a representative formalin fixed paraffin block of tumor tissue in order that the specific correlative marker assays (Correlative Studies) of this protocol may be conducted. Submission of the tissue does not have to occur prior to randomization. Where local center regulations prohibit submission of blocks of tumor tissue, two 2 mm cores of tumor from the block and 5-20 unstained slides of whole sections of representative tumor tissue are preferred. Where it is not possible to obtain two 2 mm cores of tumor from the block, 5-20 unstained slides of representative tumor tissue are also acceptable. Where no previously resected or biopsied tumor tissue exists or is available, on the approval of the Sponsor/designated CRO, the patient may still be considered eligible for the study.
  20. Patient must consent to provision of a sample of blood in order that the specific correlative marker assays (Correlative Studies) may be conducted.
  21. Patients must be accessible for treatment and follow up. Patients registered on this trial must receive protocol treatment and be followed at the participating center. This implies there must be reasonable geographical limits placed on patients being considered for this trial. Investigators must ensure that the patients randomized on this trial will be available for complete documentation of the treatment, response assessment, adverse events, and follow-up.
  22. Protocol treatment is to begin within 2 calendar days of patient randomization for patients randomized to Arm 1. Patients randomized to Arm 2 must begin protocol treatment within 7 calendar days of randomization.
  23. The patient is not receiving therapy in a concurrent clinical study and the patient agrees not to participate in other interventional clinical studies during their participation in this trial while on study treatment. Patients participating in surveys or observational studies are eligible to participate in this study.

Exclusion Criteria:

  1. Patients with no evidence of metastatic disease as well as patients with a local recurrence following surgical resection of primary lesion.
  2. Patient has experienced a decline in ECOG performance status between Baseline visit and within 72 hours prior to randomization.
  3. Patient has a > 20% decrease in serum albumin level between Baseline visit and within 72 hours prior to randomization.
  4. Patient has a > 10% decrease in weight between Baseline visit and within 72 hours prior to randomization.
  5. Any prior anti-cancer chemotherapy, biologic or investigational therapy for PDAC.

    1. Patients receiving immunotherapy for non-cancer related treatment within < 4 weeks of first planned dose of study treatment will be excluded.
    2. A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed for as long as last dose was administered > 6 months prior to randomization.
  6. Major surgery within 4 weeks prior to randomization.
  7. Any known brain or leptomeningeal metastases are excluded, even if treated.
  8. Patients with clinically significant ascites or pleural effusions.
  9. Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for 4 weeks after the last dose of napabucasin or while undergoing treatment with nab-paclitaxel and gemcitabine and for 180 days after the last dose of nab-paclitaxel and gemcitabine.
  10. Gastrointestinal disorder(s) which, in the opinion of the Principal Investigator, would significantly impede the absorption of an oral agent (e.g. active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection).
  11. Unable or unwilling to swallow napabucasin capsules daily.
  12. Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.

    1. History of cardiac disease: congestive heart failure (CHF) > New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction or coronary stenting within 6 months prior to randomization; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
    2. Current uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management) as well as prior history of hypertensive crisis or hypertensive encephalopathy.
    3. Significant vascular disease (e.g., aortic aneurysm, aortic dissection, symptomatic peripheral vascular disease including claudication, Leo Buerger's disease). Treated peripheral vascular disease that is stable for at least 6 months is allowed.
    4. Evidence of bleeding diathesis or clinically significant coagulopathy.
    5. Major surgical procedure (including open biopsy, significant traumatic injury, etc.) within 28 days, or anticipation of the need for major surgical procedure during the course of the study as well as minor surgical procedure (excluding placement of a vascular access device or bone marrow biopsy) within 7 days prior to randomization.
    6. Patients with clinically significant abnormalities on urinalysis at < 14 days prior to randomization.
    7. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization.
    8. Ongoing serious, non-healing wound, ulcer, or bone fracture.
    9. Known infection with Human Immunodeficiency Virus (HIV), and/or active infection with hepatitis B, or hepatitis C.
    10. History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
    11. History of hemolytic-uremic syndrome.
    12. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).
    13. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders that could compromise the patient's safety or the study data integrity.
  13. Known hypersensitivity to gemcitabine, taxanes or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the product or comparator Summary of Product Characteristics or Prescribing Information. Possible hypersensitivity to napabucasin or one of the excipients which include the azo dyes sunset yellow and allura red.
  14. Neurosensory neuropathy > grade 2 at baseline.
  15. Uncontrolled chronic diarrhea > grade 2 at baseline.
  16. Patients being treated with Warfarin.
  17. Patients with active, uncontrolled bacterial, viral or fungal infection(s) requiring systemic therapy
  18. Patients with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated by surgery alone or surgery plus radiotherapy with no evidence of disease continuously for > 5 years.
  19. Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
  20. Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol, including patients with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol. Patients planning to take a vacation for 14 or more consecutive days during the course of the study are ineligible.

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993731


Contacts
Contact: Boston Biomedical 617-674-6800

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Clearview Cancer Institute (CCI) Recruiting
Huntsville, Alabama, United States, 35805
United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
United States, California
Comprehensive Blood and Cancer Center Recruiting
Bakersfield, California, United States, 93309
Los Angeles Hematology Oncology Medical Group Terminated
Los Angeles, California, United States, 90017
University of Southern California Not yet recruiting
Los Angeles, California, United States, 90033
St. Joseph Hospital of Orange Recruiting
Orange, California, United States, 92868
Torrance Health Association DBA Torrance Memorial Recruiting
Redondo Beach, California, United States, 90277
UC Davis Recruiting
Sacramento, California, United States, 95817
Pacific Hematology Oncology Associates Withdrawn
San Francisco, California, United States, 94115-2376
UCLA Medical Center Santa Monica Hematology And Oncology Terminated
Santa Monica, California, United States, 90404-2125
Kaiser Permanente - Vallejo Medical Center Recruiting
Vallejo, California, United States, 94589-2441
United States, Connecticut
Norwalk Hospital The C Anthony and Jean Whittingham Cancer Center Recruiting
Norwalk, Connecticut, United States, 06850-3852
The C Anthony and Jean Whittingham Cancer Center Recruiting
Norwalk, Connecticut, United States, 06850-3852
United States, Delaware
Helen F. Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
United States, District of Columbia
Georgetown University Medical Center (GUMC) Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Florida Cancer Specialists & Research Institute Active, not recruiting
Fort Myers, Florida, United States, 33916
Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Mayo Clinic Cancer Center Recruiting
Jacksonville, Florida, United States, 32224
Cancer Specialists of North Florida Recruiting
Jacksonville, Florida, United States, 32256
Lakeland Regional Medical Center (LRMC) Withdrawn
Lakeland, Florida, United States, 33805
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
UF Health Cancer Center - Orlando Health Recruiting
Orlando, Florida, United States, 32806
Florida Cancer Specialists North Terminated
Saint Petersburg, Florida, United States, 33705
Florida Cancer Specialists East Region Active, not recruiting
Wellington, Florida, United States, 33414
United States, Georgia
University Cancer & Blood Center Recruiting
Athens, Georgia, United States, 30607
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Columbus Regional Research Institute Recruiting
Columbus, Georgia, United States, 31904
United States, Idaho
Saint Alphonsus Health System Recruiting
Boise, Idaho, United States, 83706
United States, Illinois
NorthShore University Health Systems Recruiting
Evanston, Illinois, United States, 60201
Ingalls Cancer Research Center Recruiting
Harvey, Illinois, United States, 60426
Carle Cancer Center CCOP Recruiting
Urbana, Illinois, United States, 61801
Northwestern Medicine Regional Medical Group Recruiting
Warrenville, Illinois, United States, 60555-3269
United States, Indiana
Parkview Physician Group (PPG) Recruiting
Fort Wayne, Indiana, United States, 46845
Indiana University - Melvin and Bren Simon Cancer Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
Cotton O'Neil Cancer Center Recruiting
Topeka, Kansas, United States, 66606
Cancer Center of Kansas Recruiting
Wichita, Kansas, United States, 67214
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Louisiana Hematology Oncology Associates (LHOA) Recruiting
Baton Rouge, Louisiana, United States, 70809
United States, Maine
Maine Center for Cancer Medicine - Scarborough Recruiting
Scarborough, Maine, United States, 04074-7171
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
United States, Massachusetts
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48334
United States, Minnesota
St. Luke's Hospital of Duluth Recruiting
Duluth, Minnesota, United States, 55805
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Metro MN Clinical Oncology Research Consortium Recruiting
Saint Louis Park, Minnesota, United States, 55416
United States, Mississippi
Jackson Oncology Associates Recruiting
Jackson, Mississippi, United States, 39202
United States, Missouri
University of Missouri - Ellis Fischel Cancer Cent Recruiting
Columbia, Missouri, United States, 65212
Saint Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
HCA Midwest Division (Kansas City) Terminated
Kansas City, Missouri, United States, 64132
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110-1032
Mercy Clinic - Cancer & Hematology Recruiting
Springfield, Missouri, United States, 65804
United States, Montana
St. Vincent Frontier Cancer Center Recruiting
Billings, Montana, United States, 59102
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
United States, New Jersey
Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
United States, New Mexico
UNM Cancer Research and Treatment Center Recruiting
Albuquerque, New Mexico, United States, 87131
San Juan Oncology Associates Recruiting
Farmington, New Mexico, United States, 87401
United States, New York
Montefiore Cancer Center Recruiting
Bronx, New York, United States, 10467
Basset Medical Center Recruiting
Cooperstown, New York, United States, 13326
North Shore Hematology Oncology Associates PC Recruiting
East Setauket, New York, United States, 11733
Hematology Oncology Associates of Central New York Recruiting
East Syracuse, New York, United States, 13057
Clinical Research Alliance Recruiting
Lake Success, New York, United States, 11042
Weill Cornell Medicine/ NewYork-Presbyterian Recruiting
New York, New York, United States, 10021
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
United States, North Carolina
UNC Chapel Hill / Lineberger Comprehensive Cancer Recruiting
Chapel Hill, North Carolina, United States, 27599
Southeastern Medical Oncology Center Recruiting
Goldsboro, North Carolina, United States, 27534
Cone Health Cancer Center Recruiting
Greensboro, North Carolina, United States, 27403
FirstHealth Outpatient Cancer Center Recruiting
Pinehurst, North Carolina, United States, 28374
Wake Forest Baptist Hospital Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Gabrail Cancer Center (GCC) - Canton Facility Recruiting
Canton, Ohio, United States, 44718
Toledo Clinic Cancer Centers Recruiting
Toledo, Ohio, United States, 43623-3536
United States, Oklahoma
Cancer Center of Southwest Oklahoma Recruiting
Lawton, Oklahoma, United States, 73505
Mercy Clinic Oncology and Hematology - McAuley Recruiting
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Kaiser Permanente - Westside Medical Office Recruiting
Hillsboro, Oregon, United States, 97124-5806
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97120
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Terminated
Hershey, Pennsylvania, United States, 17033
Fox Chase Cancer Center (FCCC) - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19111-2434
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Charleston Hematology Oncology Associates Recruiting
Charleston, South Carolina, United States, 29414
Medical University of South Carolina (MUSC) Recruiting
Charleston, South Carolina, United States, 29425-8900
Saint Francis Cancer Center Recruiting
Greenville, South Carolina, United States, 29607-5253
GHS Cancer Institute Recruiting
Greenville, South Carolina, United States, 29615
United States, South Dakota
Avera Medical Group Recruiting
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Tennessee Oncology Chattanooga Active, not recruiting
Chattanooga, Tennessee, United States, 37404
University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
SCRI - Tennessee Oncology Active, not recruiting
Nashville, Tennessee, United States, 37203-1625
United States, Texas
The Center for Cancer and Blood Disorders Recruiting
Fort Worth, Texas, United States, 76104
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Bon Secours Cancer Institute Medical Oncology Recruiting
Midlothian, Virginia, United States, 23114-3203
Virginia Cancer Institute Recruiting
Richmond, Virginia, United States, 23226
Oncology and Hematology Associates of Southwest Virginia Recruiting
Roanoke, Virginia, United States, 24014
United States, Washington
The Everett Clinic Recruiting
Everett, Washington, United States, 98201
MultiCare Institute for Research and Innovation Recruiting
Tacoma, Washington, United States, 98405
United States, West Virginia
West Virginia University Mary Babb Randolph Cancer Center (MBRCC) Recruiting
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
HSHS St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology, Ltd. - West Green Bay Recruiting
Green Bay, Wisconsin, United States, 54303
Aurora St. Luke's Medical Center - Vince Lombardi Recruiting
Milwaukee, Wisconsin, United States, 53215-4330
Australia, New South Wales
Border Medical Oncology Recruiting
East Albury, New South Wales, Australia, 2109
Macquarie University Hospital Recruiting
Sydney, New South Wales, Australia, 2109
Australia, South Australia
ICON Cancer Care Recruiting
South Brisbane, South Australia, Australia, 4101
Australia, Victoria
Cabrini Hospital Recruiting
Malvern, Victoria, Australia, 3144
Australia
Blacktown Cancer and Haematology Centre Recruiting
Blacktown, Australia, 2148
Border Medical Oncology Recruiting
East Albury, Australia, 2640
The Austin Hospital Recruiting
Heidelberg, Australia, 3084
Cabrini Hospital Recruiting
Malvern, Australia, 3144
Sir Charles Gairdner Hospital Recruiting
Nedlands, Australia, 6009
Prince of Wales Private Hospital Recruiting
Randwick, Australia, 2031
ICON Cancer Care Recruiting
South Brisbane, Australia, 4101
Macquarie University Hospital Recruiting
Sydney, Australia, 2109
The Tweed Hospital Recruiting
Tweed Heads, Australia, 2485
Sydney Adventist Hospital Recruiting
Wahroonga, Australia, 2076
Austria
LKH Universitätsklinikum Graz Recruiting
Graz, Austria, 8036
Landeskrankenhaus Medical University Innsbruck Recruiting
Innsbruck, Austria, 6020
Landeskrankenhaus Feldkirch Recruiting
Rankweil, Austria, 6830
Universitatsklinik far Innere Medizin III Recruiting
Salzburg, Austria, 5020
Medical University Vienna Recruiting
Vienna, Austria, 1090
Belgium
ULB Erasme Recruiting
Bruxelles, Belgium, 13-1070
Antwerp University Hospital Recruiting
Edegem, Belgium, B-2650
UZ Ghent Recruiting
Gent, Belgium, 9000
UZ Brussel Recruiting
Jette, Belgium, 1070
UZ Leuven Recruiting
Leuven, Belgium, 3000
CHU de Liege Recruiting
Liège, Belgium, 4000
CHU Dinant Godinne Recruiting
Yvoir, Belgium, 5530
Canada, New Brunswick
Dr. Everett Chalmers Regional Hospital Recruiting
Fredericton, New Brunswick, Canada, E3B 5N5
Canada, Nova Scotia
The Atlantic Clinical Cancer Research Unit (ACCRU) Recruiting
Halifax, Nova Scotia, Canada, B3H 1C2
Canada, Quebec
Centre Hospitalier de St. Mary Recruiting
Pointe-Claire, Quebec, Canada, H9R 2Y2
Ciusssmcq Recruiting
Trois-Rivières, Quebec, Canada, G8Z 3R9
Canada
Cross Cancer Institute Recruiting
Edmonton, Canada, T6G 1Z2
University of Toronto - St. Michael's Hospital Recruiting
Toronto, Canada, M5B 1W8
Czechia
Onkologicke oddeleni Recruiting
Benešov, Czechia, 25601
Fakultni nemocnice Brno Interni hematoonkologicka klinika Recruiting
Brno, Czechia, 62500
Fakultni nemocnice Hradec Kralove Recruiting
Hradec Kralove, Czechia, 50005
University Hospital Olomouc Recruiting
Olomouc, Czechia, 77906
Onkologické oddělení Recruiting
Zlín, Czechia, 762 75
France
Hôpital Sud - CHU Amiens Picardie Recruiting
Amiens, France, 80054
Hôpital Trousseau, CHRU de Tours Recruiting
Chambray-lès-Tours, France, 37170
Hopital Edourard Herriot Recruiting
Lyon Cedex 03, France, 69437
CHU-Hôtel Dieu Recruiting
Nantes Cedex 1, France, 44093
Centre Antoine Lacassagne Recruiting
Nice, France, 06100
Hopital Europeen Georges Pompidou Recruiting
Paris, France, 75015
Poitiers University Hospital Recruiting
Poitiers, France, 86021
Centre Eugene Marquis Recruiting
Rennes, France, 35042
Clinique Saint Anne Recruiting
Strasbourg, France, 67000
Hopital Civil de strasbourg Recruiting
Strasbourg, France, 67091
Institute de Cancerologie de Lorraine Recruiting
Vandœuvre-lès-Nancy, France, 54519
Germany
Gesundheitszentrum St. Marien GmbH Recruiting
Amberg, Germany, 92224
University Hospital Bonn Recruiting
Bonn, Germany, 53127
Klinikum Chemnitz Recruiting
Chemnitz, Germany, 09116
Krankenhaus Nordwest Recruiting
Frankfurt am main, Germany, 60488
Medizinische Hochschule Recruiting
Hannover, Germany, 30625
SLK-Kliniken Heilbronn GmbH Recruiting
Heilbronn, Germany, 74078
Universitätsmedizin Mannheim Recruiting
Mannheim, Germany, 68167
Klinikum Bogenhausen Recruiting
München, Germany, 81925
Klinikum Oldenburg AöR - UK für Innere Medizin Recruiting
Oldenburg, Germany, 26133
Italy
Fondazione Poliambulanza Recruiting
Brescia, Italy, 25124
Istituto Ricerca e la Cura del Cancro (IRCC) Recruiting
Candiolo, Italy, 10060
Ospedale degli Infermi Recruiting
Faenza, Italy, 48018
Santa Maria de Prato Hospital Recruiting
Feltre, Italy, 32032
AOU Mater Domini Recruiting
Germaneto Catanzaro, Italy, 88200
IRCCS - Studio e la Cura dei Tumori Recruiting
Meldola, Italy, 47014
IRCCS Ospedale San Raffaele Recruiting
Milano, Italy, 20132
AO SM Misericordia Recruiting
Perugia, Italy, 06132
IRCCS Azienda Ospedaliera S.Maria Nuova Recruiting
Reggio Emilia, Italy, 42123
Ospedale degli Infermi Recruiting
Rimini, Italy, 47923
Dermatological Hospital San Lazzaro Recruiting
Torino, Italy, 10126
ASST Settelaghi Recruiting
Varese, Italy, 21100
Japan
Aichi Cancer Center Hospital Active, not recruiting
Nagoya, Aichi, Japan, 464-8681
Shikoku Cancer Center Active, not recruiting
Matsuyama, Ehime, Japan, 791-0280
Hokkaido University Hospital Active, not recruiting
Sapporo, Hokkaido, Japan, 060-8648
Kanagawa Cancer Center Active, not recruiting
Yokohama, Kanagawa, Japan, 241-8515
Kyoto University Hospital Active, not recruiting
Sakyo-ku, Kyoto, Japan, 606-8507
Saitama Cancer Center Active, not recruiting
Kita Adachi-gun, Saitama, Japan, 362-0806
Shizuoka Cancer Center Active, not recruiting
Sunto, Shizuoka, Japan, 411-8777
Tochigi Cancer Center Active, not recruiting
Utsunomiya, Tochigi, Japan, 320-0834
University of Tokyo Hospital Active, not recruiting
Bunkyō-Ku, Tokyo, Japan, 113-8655
National Cancer Center Hospital Active, not recruiting
Chuo-ku, Tokyo, Japan, 104-0045
The Cancer Institute Hospital Of JFCR Active, not recruiting
Koto-Ku, Tokyo, Japan, 135-8550
Kyorin University Hopsital Active, not recruiting
Mitaka, Tokyo, Japan, 181-8611
Osaka International Cancer Institute Active, not recruiting
Osaka, Japan, 541-8567
Korea, Republic of
Seoul national University Bundang Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 13620
Chonnam National University Hwasun Hospital Recruiting
Jeongnam, Korea, Republic of, 58128
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 08308
Netherlands
Academisch Medisch Centrum Withdrawn
Amsterdam, Netherlands, 1105 AZ
Medisch Centrum Leeuwarden (MCL) Recruiting
Leeuwarden, Netherlands, 8934 AD
Zuyderland Medical Center Active, not recruiting
Sittard, Netherlands, 6162 BG
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Isala Ziekenhuis Recruiting
Zwolle, Netherlands, 8025 AB
Poland
Uniwersyteckie Centrum Kliniczne Recruiting
Gdańsk, Poland, 80-952
Centrum Onkologii-Instytut im.M.Sklodowskiej-Curie Recruiting
Gliwice, Poland, 44-101
Przychodnia Lekarska KOMED Recruiting
Konin, Poland, 62-500
Klinika Chirurgii Onkologicznej Recruiting
Lublin, Poland, 20-081
Centrum Onkologii Ziemi Lubelskiej Recruiting
Lublin, Poland, 20-090
Samodzielny Publiczny Szpital Kliniczny Recruiting
Poznań, Poland, 44-400
Wojewodzki Szpital Zespolony Recruiting
Toruń, Poland, 87-100
Portugal
Fundação Champalimaud Recruiting
Lisboa, Portugal, 1400-038
Hospital da Luz Recruiting
Lisboa, Portugal, 1500-650
Centro Hospitalar Lisboa Norte Recruiting
Lisbon, Portugal, 1649-035
Centro Hospitalar do Porto, E.P.E Recruiting
Porto, Portugal, 4099-001
IPO Porto Francisco Gentil, E.P.E. Recruiting
Porto, Portugal, 4200-072
Centro Hospitalar Entre Douro e Vouga Recruiting
Santa Maria Da Feira, Portugal, 4520-211
Russian Federation
Kursk Regional Clinical Oncology Dispensary Active, not recruiting
Kislino, Kursk, Russian Federation, 305524
Arkhangelsk Regional Clinical Oncology Dispensary Active, not recruiting
Arkhangel'sk, Russian Federation, 163046
Republican Clinical Oncology Dispensary Active, not recruiting
Cheboksary, Russian Federation, 428020
Llc Evimed Active, not recruiting
Chelyabinsk, Russian Federation, 454087
Railway Clinical Hospital on station Chelyabinsk Active, not recruiting
Chelyabinsk, Russian Federation, 454091
Republic Clinical Oncology Dispensary Active, not recruiting
Kazan, Russian Federation, 420029
N.N. Blokhin Russian Cancer Research Center Active, not recruiting
Moscow, Russian Federation, 115478
Privolzhsk District Medical Center Active, not recruiting
Nizhny Novgorod, Russian Federation, 603006
Budgetary Healthcare Institution of Omsk Region Active, not recruiting
Omsk, Russian Federation, 644013
Orenburg Regional Clinical Oncology Dispensary Active, not recruiting
Orenburg, Russian Federation, 460021
Pyatigorsk Oncology Dispensary Active, not recruiting
Pyatigorsk, Russian Federation, 357502
St.Petersburg Medical Universitet n.a. I.P. Pavlov Active, not recruiting
Saint Petersburg, Russian Federation, 197022
FSBI "Russian Research Centre of Radiology and Surgical Technologies" Active, not recruiting
Saint Petersburg, Russian Federation, 197758
City Clinical Oncology Dispensary Active, not recruiting
Saint Petersburg, Russian Federation, 198255
Multi-type clinic 'REAVIZ' Active, not recruiting
Samara, Russian Federation, 443011
National Research Mordovia State University Active, not recruiting
Saransk, Russian Federation, 430032
Singapore
National Cancer Centre Singapore Recruiting
Singapore, Singapore, 169610
Tan Tock Seng Hospital Recruiting
Singapore, Singapore, 308433
Spain
Hospital Vall d´Hebron Recruiting
Barcelona, Spain, 08035
Hospital Clínico y Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
(ICO) Hospital Duran i Reynals Recruiting
Barcelona, Spain, 08916
Hospital Universitario Germans Trias i Pujol Recruiting
Barcelona, Spain, 08916
Hospital Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Centro Integral Oncologico Clara Campal Recruiting
Madrid, Spain, 28050
Hospital Universitario Puerta de Hierro Recruiting
Madrid, Spain, 28220
Hospital Universitario Fundacion Alcorcon Recruiting
Madrid, Spain, 28922
Hospital Regional Universitario de Málaga Recruiting
Málaga, Spain, 29010
Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung City, Taiwan, 833
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Taipei Veterans General Hospital Recruiting
Taipei City, Taiwan, 11217
LinKou Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Ukraine
Zaytsev Institute General and Urgent Surgery of National Academy Medical Science of Ukraine Recruiting
Kharkiv, Ukraine, 61005
National Institute of Cancer Recruiting
Kyiv, Ukraine, 03022
Sponsors and Collaborators
Boston Biomedical, Inc
Investigators
OverallOfficial: Boston Biomedical

Responsible Party: Boston Biomedical, Inc
ClinicalTrials.gov Identifier: NCT02993731     History of Changes
Other Study ID Numbers: CanStem111P
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Keywords provided by Boston Biomedical, Inc:
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

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma, Pancreatic Ductal
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Ductal
Neoplasms, Ductal, Lobular, and Medullary
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents