Back to resultsStudy of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
Primary Purpose
Metastatic Pancreatic Adenocarcinoma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ibrutinib
Gemcitabine
Nab-paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
- Stage IV disease diagnosed within 6 weeks of randomization
Adequate hematologic function:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L
- Platelet count ≥100 x 109/L
- Hemoglobin ≥9 g/dL
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
- PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN
- KPS ≥70.
- Eastern Cooperative Oncology Group (ECOG) 0-1
Exclusion Criteria:
- Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
- Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
- Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).
- Major surgery within 4 weeks of first dose of study drug.
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- Treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
Sites / Locations
- Oncology Specialties, PC; Clearview Cancer Institute
- Arizona Center for Cancer Care
- St. Mary's Medical Center
- Moores UCSD Cancer Center
- Cedars Sinai Medical Center
- Norwalk Hospital
- Eastern Connecticut Hematology/Oncology Assoc.
- Bethesda Memorial Hospital
- Florida Hospital Tampa
- University Cancer & Blood Center, LLC
- Northwest Georgia Oncology Centers, PC
- Ingalls Memorial Hospital Cancer Research Center
- Joliet Oncology-Hematology Associates, LTD
- Investigative Clinical Research of Indiana
- Mary Bird Perkins Cancer Center
- Our Lady of the Lake Physician Group
- Center for Cancer and Blood Disorders
- Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion Center
- Saint Joseph Mercy Health System
- Sparrow Regional Cancer Center
- Nebraska Medicine - Peggy D. Cowdery Patient Care Center
- The Presbyterian Hospital
- University of Cincinnati Medical Center
- Penn State University Milton S. Hershey Medical Center
- Gibbs Cancer Center
- Scott & White Memorial Hospital
- MultiCare Health System Institute for Research and Innovation
- Wenatchee Valley Hospital & Clinics
- ULB Hôpital Erasme
- Cliniques Universitaires Saint-Luc
- Grand Hôpital de Charleroi
- UZ Leuven
- C. H. U. Sart Tilman
- Centre Antoine Lacassagne
- Centre Paul Strauss
- Hôpital de la Timone
- Centre Georges François Leclerc
- CHU Besançon - Hôpital Jean Minjoz
- Groupe Hospitalier Saint André - Hôpital Saint André
- CHU de Toulouse - Hôpital Rangueil
- Hôpital Nord Franche Comté
- Hôpital Saint-Antoine
- CHU Poitiers - Hôpital la Milétrie
- Groupe Hospitalier Pitie-Salpetriere
- Universitaetsklinikum Tuebingen
- Universitaetsklinikum Ulm
- Klinikum der Johann Wolfgang Goethe-Universitaet
- Universitaetsklinikum Koeln
- Gemeinschaftspraxis Haematologie und Onkologie
- Universitaetsklinikum Leipzig AoeR
- Onkologische Schwerpunktpraxis Kurfuerstendamm
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- Azienda Ospedaliero Universitaria San Martino
- Ospedale San Raffaele
- IEO Istituto Europeo di Oncologia
- Azienda Ospedaliera Ospedale Niguarda Ca' Granda
- Istituto Nazionale Tumori Fondazione G. Pascale
- IOV - Istituto Oncologico Veneto IRCCS
- Fondazione IRCCS Policlinico San Matteo
- Azienda Ospedaliero Universitaria Pisana
- IRCCS Ospedale Casa Sollievo della Sofferenza
- Seoul National University Bundang Hospital
- Chonnam National University Hwasun Hospital
- Seoul National University Hospital
- Yonsei University Health System
- Asan Medical Center
- Samsung Medical Center
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Korea University Guro Hospital
- ICO l´Hospitalet - Hospital Duran i Reynals
- Hospital del Mar
- Specialist
- Hospital Universitari Vall d'Hebron
- Hospital Clinic i Provincial de Barcelona
- Hospital Universitario 12 de Octubre
- Hospital Universitario La Paz
- Hospital Clinico Universitario Virgen de la Victoria
- Hospital Universitario Virgen Macarena
- Hospital Universitario Virgen del Rocio
- Derriford Hospital
- Broomfield Hospital
- The Christie
- Southampton General Hospital
- The Clatterbridge Cancer Centre
- Royal Marsden Hospital
- Royal Free Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ibrutinib
Placebo
Arm Description
Ibrutinib daily in combination with: Nab-paclitaxel and gemcitabine
Placebo daily in combination with: Nab-paclitaxel and gemcitabine
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization until disease progression per RECIST 1.1 criteria assessed by investigator, or death from any cause, whichever occurs first.
Overall Survival (OS)
OS, is defined as the time from date of randomization until date of death from any cause.
Secondary Outcome Measures
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.
This is a measure of percentage of subjects with Treatment Emergent Adverse Events Grade 3 or above collected Up to 30 days after the last participating subject discontinues study drug.
Overall Response Rate
ORR is defined as the percentage of subjects who achieve a complete response or partial response, based on investigator assessment according to RECIST 1.1.
Clinical Benefit Response
Subject achieved a ≥50% reduction in pain intensity (Memorial Pain Assessment Card [MPAC]) or analgesic consumption, or a 20-point or greater improvement in KPS for a period of at least 4 consecutive weeks, without showing any sustained worsening in other parameters.
OR Subject was stable on all of the aforementioned parameters, and showed a marked, sustained weight gain (≥7% increase maintained for ≥4 weeks) not due to fluid accumulation (Burris 1997).
Carbohydrate Antigen 19-9 (CA19-9) Response
The CA19-9 response rate is defined as the percentage of subjects with a decline of 20%, 90%, and other thresholds considered clinically meaningful, from baseline. This is a percentage of patients with > or = 60% reduction from baseline.
Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).
Unit is the month: TUDD1 - the time between random & 1st occurrence of a decrease in QLQ-C30 score ≥10 pts w/o improvement in QoL score of ≥10 points or any further QoL data due to deterioration. The proportion of subjects who met the "responder" criteria prior to subsequent anticancer therapy initiation. Response defined as achievement of a ≥50% reduction in MPAC visual analog scale which measures pain intensity or analgesic consumption, or a ≥20-point improvement from baseline in KPS sustained for a period of ≥ 4 consecutive weeks without showing any sustained worsening from baseline in any of the other parameters OR Subject stable on all parameters (pain and KPS), & showed a marked, sustained weight gain (≥7% increase from baseline maintained for ≥4 weeks) not due to fluid accumulation.
Rate of Venous Thromboembolic Events (VTE)
The VTE rate is defined as percentage of subjects with Venous thromboembolic events (SMQ) per investigator assessment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02436668
Brief Title
Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
Official Title
A Randomized, Multicenter, Double-blind, Placebo-controlled, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
April 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacyclics LLC.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a phase 3 study to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
430 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibrutinib
Arm Type
Active Comparator
Arm Description
Ibrutinib daily in combination with:
Nab-paclitaxel and gemcitabine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
IMBRUVICA®
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from the date of randomization until disease progression per RECIST 1.1 criteria assessed by investigator, or death from any cause, whichever occurs first.
Time Frame
Results at an overall median follow-up of 24.87 months
Title
Overall Survival (OS)
Description
OS, is defined as the time from date of randomization until date of death from any cause.
Time Frame
Results at an overall median follow-up of 24.87 months
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.
Description
This is a measure of percentage of subjects with Treatment Emergent Adverse Events Grade 3 or above collected Up to 30 days after the last participating subject discontinues study drug.
Time Frame
Results at an overall median follow-up of 24.87 months
Title
Overall Response Rate
Description
ORR is defined as the percentage of subjects who achieve a complete response or partial response, based on investigator assessment according to RECIST 1.1.
Time Frame
Results at an overall median follow-up of 24.87 months
Title
Clinical Benefit Response
Description
Subject achieved a ≥50% reduction in pain intensity (Memorial Pain Assessment Card [MPAC]) or analgesic consumption, or a 20-point or greater improvement in KPS for a period of at least 4 consecutive weeks, without showing any sustained worsening in other parameters.
OR Subject was stable on all of the aforementioned parameters, and showed a marked, sustained weight gain (≥7% increase maintained for ≥4 weeks) not due to fluid accumulation (Burris 1997).
Time Frame
Results at an overall median follow-up of 24.87 months
Title
Carbohydrate Antigen 19-9 (CA19-9) Response
Description
The CA19-9 response rate is defined as the percentage of subjects with a decline of 20%, 90%, and other thresholds considered clinically meaningful, from baseline. This is a percentage of patients with > or = 60% reduction from baseline.
Time Frame
Results at an overall median follow-up of 24.87 months
Title
Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).
Description
Unit is the month: TUDD1 - the time between random & 1st occurrence of a decrease in QLQ-C30 score ≥10 pts w/o improvement in QoL score of ≥10 points or any further QoL data due to deterioration. The proportion of subjects who met the "responder" criteria prior to subsequent anticancer therapy initiation. Response defined as achievement of a ≥50% reduction in MPAC visual analog scale which measures pain intensity or analgesic consumption, or a ≥20-point improvement from baseline in KPS sustained for a period of ≥ 4 consecutive weeks without showing any sustained worsening from baseline in any of the other parameters OR Subject stable on all parameters (pain and KPS), & showed a marked, sustained weight gain (≥7% increase from baseline maintained for ≥4 weeks) not due to fluid accumulation.
Time Frame
Results at an overall median follow-up of 24.87 months
Title
Rate of Venous Thromboembolic Events (VTE)
Description
The VTE rate is defined as percentage of subjects with Venous thromboembolic events (SMQ) per investigator assessment.
Time Frame
Results at an overall median follow-up of 24.87 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
Stage IV disease diagnosed within 6 weeks of randomization
Adequate hematologic function:
Absolute neutrophil count (ANC) ≥1.5 x 109/L
Platelet count ≥100 x 109/L
Hemoglobin ≥9 g/dL
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
PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN
KPS ≥70.
Eastern Cooperative Oncology Group (ECOG) 0-1
Exclusion Criteria:
Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).
Major surgery within 4 weeks of first dose of study drug.
History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
Treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Cole, MD
Organizational Affiliation
Pharmacyclics LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Oncology Specialties, PC; Clearview Cancer Institute
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Arizona Center for Cancer Care
City
Avondale
State/Province
Arizona
ZIP/Postal Code
85323
Country
United States
Facility Name
St. Mary's Medical Center
City
Daly City
State/Province
California
ZIP/Postal Code
94015
Country
United States
Facility Name
Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Eastern Connecticut Hematology/Oncology Assoc.
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Bethesda Memorial Hospital
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33425
Country
United States
Facility Name
Florida Hospital Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
University Cancer & Blood Center, LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Northwest Georgia Oncology Centers, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Ingalls Memorial Hospital Cancer Research Center
City
Harvey
State/Province
Illinois
ZIP/Postal Code
64026
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, LTD
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Investigative Clinical Research of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Mary Bird Perkins Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Our Lady of the Lake Physician Group
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion Center
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Saint Joseph Mercy Health System
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Nebraska Medicine - Peggy D. Cowdery Patient Care Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
The Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Penn State University Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Gibbs Cancer Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Scott & White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
MultiCare Health System Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Wenatchee Valley Hospital & Clinics
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
ULB Hôpital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Grand Hôpital de Charleroi
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
C. H. U. Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Centre Antoine Lacassagne
City
Nice cedex 02
State/Province
Alpes Maritimes
ZIP/Postal Code
06189
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg cedex
State/Province
Bas Rhin
ZIP/Postal Code
67091
Country
France
Facility Name
Hôpital de la Timone
City
Marseille cedex 5
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon cedex
State/Province
Côte-d'Or
ZIP/Postal Code
21079
Country
France
Facility Name
CHU Besançon - Hôpital Jean Minjoz
City
Besançon
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Facility Name
Groupe Hospitalier Saint André - Hôpital Saint André
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33000
Country
France
Facility Name
CHU de Toulouse - Hôpital Rangueil
City
Toulouse Cedex 9
State/Province
Haute Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Hôpital Nord Franche Comté
City
Doubs
State/Province
Montbeliard
ZIP/Postal Code
25209
Country
France
Facility Name
Hôpital Saint-Antoine
City
Paris cedex 12
State/Province
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
CHU Poitiers - Hôpital la Milétrie
City
Poitiers Cedex
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
State/Province
Baden Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
State/Province
Baden Wuerttemberg
ZIP/Postal Code
89070
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Koeln
City
Koeln
State/Province
Nordrhein Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Gemeinschaftspraxis Haematologie und Onkologie
City
Dresden
State/Province
Sachsen Anhalt
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Leipzig AoeR
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Kurfuerstendamm
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
City
Ancona
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
IEO Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
IOV - Istituto Oncologico Veneto IRCCS
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
ICO l´Hospitalet - Hospital Duran i Reynals
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Specialist
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Derriford Hospital
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8BQ
Country
United Kingdom
Facility Name
Broomfield Hospital
City
Chelmsford
State/Province
Essex
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
The Christie
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
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