Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
NCT ID: NCT02436668
Last Updated: 2020-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
430 participants
INTERVENTIONAL
2015-05-31
2019-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ibrutinib
Ibrutinib daily in combination with:
Nab-paclitaxel and gemcitabine
Ibrutinib
Gemcitabine
Nab-paclitaxel
Placebo
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine
Gemcitabine
Nab-paclitaxel
Interventions
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Ibrutinib
Gemcitabine
Nab-paclitaxel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Stage IV disease diagnosed within 6 weeks of randomization
3. Adequate hematologic function:
* Absolute neutrophil count (ANC) ≥1.5 x 109/L
* Platelet count ≥100 x 109/L
* Hemoglobin ≥9 g/dL
4. Adequate hepatic and renal function defined as:
* AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3 x ULN without liver metastases
* Alkaline phosphatase \<3.0 x ULN or ≤5.0 x ULN if liver or bone metastases present
* Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)
* Estimated Creatinine Clearance ≥30 mL/min
5. PT/INR \<1.5 x ULN and PTT (aPTT) \<1.5 x ULN
6. KPS ≥70.
7. Eastern Cooperative Oncology Group (ECOG) 0-1
Exclusion Criteria
2. Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
3. Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).
4. Major surgery within 4 weeks of first dose of study drug.
5. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
6. Treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
18 Years
ALL
No
Sponsors
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Pharmacyclics LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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George Cole, MD
Role: STUDY_DIRECTOR
Pharmacyclics LLC.
Locations
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Oncology Specialties, PC; Clearview Cancer Institute
Huntsville, Alabama, United States
Arizona Center for Cancer Care
Avondale, Arizona, United States
St. Mary's Medical Center
Daly City, California, United States
Moores UCSD Cancer Center
La Jolla, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Eastern Connecticut Hematology/Oncology Assoc.
Norwich, Connecticut, United States
Bethesda Memorial Hospital
Boynton Beach, Florida, United States
Florida Hospital Tampa
Tampa, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States
Ingalls Memorial Hospital Cancer Research Center
Harvey, Illinois, United States
Joliet Oncology-Hematology Associates, LTD
Joliet, Illinois, United States
Investigative Clinical Research of Indiana
Indianapolis, Indiana, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion Center
Pittsfield, Massachusetts, United States
Saint Joseph Mercy Health System
Chelsea, Michigan, United States
Sparrow Regional Cancer Center
Lansing, Michigan, United States
Nebraska Medicine - Peggy D. Cowdery Patient Care Center
Omaha, Nebraska, United States
The Presbyterian Hospital
Charlotte, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Gibbs Cancer Center
Spartanburg, South Carolina, United States
Scott & White Memorial Hospital
Temple, Texas, United States
MultiCare Health System Institute for Research and Innovation
Tacoma, Washington, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States
ULB Hôpital Erasme
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Grand Hôpital de Charleroi
Gilly, , Belgium
UZ Leuven
Leuven, , Belgium
C. H. U. Sart Tilman
Liège, , Belgium
Centre Antoine Lacassagne
Nice, Alpes Maritimes, France
Centre Paul Strauss
Strasbourg, Bas Rhin, France
Hôpital de la Timone
Marseille, Bouches-du-Rhône, France
Centre Georges François Leclerc
Dijon, Côte-d'Or, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, Doubs, France
Groupe Hospitalier Saint André - Hôpital Saint André
Bordeaux, Gironde, France
CHU de Toulouse - Hôpital Rangueil
Toulouse, Haute Garonne, France
Hôpital Nord Franche Comté
Doubs, Montbeliard, France
Hôpital Saint-Antoine
Paris, Paris, France
CHU Poitiers - Hôpital la Milétrie
Poitiers, Vienne, France
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, Saxony, Germany
Gemeinschaftspraxis Haematologie und Onkologie
Dresden, Saxony-Anhalt, Germany
Onkologische Schwerpunktpraxis Kurfuerstendamm
Berlin, , Germany
Azienda Ospedaliero Universitaria Ospedali Riuniti
Ancona, , Italy
Azienda Ospedaliero Universitaria San Martino
Genova, , Italy
Ospedale San Raffaele
Milan, , Italy
IEO Istituto Europeo di Oncologia
Milan, , Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, , Italy
IOV - Istituto Oncologico Veneto IRCCS
Padua, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
ICO l´Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital del Mar
Barcelona, , Spain
Specialist
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Derriford Hospital
Plymouth, Devon, United Kingdom
Broomfield Hospital
Chelmsford, Essex, United Kingdom
The Christie
Manchester, Greater Manchester, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
The Clatterbridge Cancer Centre
Liverpool, Merseyside, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Royal Free Hospital
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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PCYC-1137-CA
Identifier Type: -
Identifier Source: org_study_id