Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)

December 7, 2020 updated by: Pharmacyclics LLC.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
430

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

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

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Bruxelles, Belgium, 1070
        • ULB Hôpital Erasme
      • Gilly, Belgium, 6060
        • Grand Hôpital de Charleroi
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • C. H. U. Sart Tilman
  • France
      • Paris, France, 75013
        • Groupe Hospitalier Pitie-Salpetriere
    • Alpes Maritimes
      • Nice cedex 02, Alpes Maritimes, France, 06189
        • Centre Antoine Lacassagne
    • Bas Rhin
      • Strasbourg cedex, Bas Rhin, France, 67091
        • Centre Paul Strauss
    • Bouches-du-Rhône
      • Marseille cedex 5, Bouches-du-Rhône, France, 13385
        • Hopital De La Timone
    • Côte-d'Or
      • Dijon cedex, Côte-d'Or, France, 21079
        • Centre Georges Francois Leclerc
    • Doubs
      • Besançon, Doubs, France, 25030
        • CHU Besançon - Hôpital Jean Minjoz
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • Groupe Hospitalier Saint André - Hôpital Saint André
    • Haute Garonne
      • Toulouse Cedex 9, Haute Garonne, France, 31059
        • CHU de Toulouse - Hôpital Rangueil
    • Montbeliard
      • Doubs, Montbeliard, France, 25209
        • Hôpital Nord Franche Comté
    • Paris
      • Paris cedex 12, Paris, France, 75571
        • Hôpital Saint-Antoine
    • Vienne
      • Poitiers Cedex, Vienne, France, 86021
        • CHU Poitiers - Hôpital la Milétrie
  • Germany
      • Berlin, Germany, 10707
        • Onkologische Schwerpunktpraxis Kurfuerstendamm
    • Baden Wuerttemberg
      • Tuebingen, Baden Wuerttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen
      • Ulm, Baden Wuerttemberg, Germany, 89070
        • Universitaetsklinikum Ulm
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Klinikum Der Johann Wolfgang Goethe-Universitaet
    • Nordrhein Westfalen
      • Koeln, Nordrhein Westfalen, Germany, 50937
        • Universitaetsklinikum Koeln
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Universitaetsklinikum Leipzig Aoer
    • Sachsen Anhalt
      • Dresden, Sachsen Anhalt, Germany, 01307
        • Gemeinschaftspraxis Haematologie und Onkologie
  • Italy
      • Ancona, Italy
        • Azienda Ospedaliero Universitaria Ospedali Riuniti
      • Genova, Italy, 16132
        • Azienda Ospedaliero Universitaria San Martino
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Milano, Italy, 20141
        • IEO Istituto Europeo di Oncologia
      • Milano, Italy, 20162
        • Azienda Ospedaliera Ospedale Niguarda Ca' Granda
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori Fondazione G. Pascale
      • Padova, Italy, 35128
        • IOV - Istituto Oncologico Veneto IRCCS
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • San Giovanni Rotondo, Italy, 71013
        • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03722
        • Yonsei University Health System
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08006
        • specialist
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Málaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • ICO l´Hospitalet - Hospital Duran i Reynals
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8BQ
        • Derriford Hospital
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • Broomfield Hospital
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • The Christie
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Southampton General Hospital
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8XP
        • The Clatterbridge Cancer Centre
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Oncology Specialties, PC; Clearview Cancer Institute
    • Arizona
      • Avondale, Arizona, United States, 85323
        • Arizona Center for Cancer Care
    • California
      • Daly City, California, United States, 94015
        • St. Mary's Medical Center
      • La Jolla, California, United States, 92093
        • Moores UCSD Cancer Center
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology/Oncology Assoc.
    • Florida
      • Boynton Beach, Florida, United States, 33425
        • Bethesda Memorial Hospital
      • Tampa, Florida, United States, 33613
        • Florida Hospital Tampa
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer & Blood Center, LLC
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, PC
    • Illinois
      • Harvey, Illinois, United States, 64026
        • Ingalls Memorial Hospital Cancer Research Center
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, LTD
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Investigative Clinical Research of Indiana
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center
      • Baton Rouge, Louisiana, United States, 70809
        • Our Lady of the Lake Physician Group
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion Center
    • Michigan
      • Chelsea, Michigan, United States, 48118
        • Saint Joseph Mercy Health System
      • Lansing, Michigan, United States, 48912
        • Sparrow Regional Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Nebraska Medicine - Peggy D. Cowdery Patient Care Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • The Presbyterian Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State University Milton S. Hershey Medical Center
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Cancer Center
    • Texas
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Health System Institute for Research and Innovation
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Hospital & Clinics

Participation Criteria

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

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
  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:

  1. Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
  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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ibrutinib

Ibrutinib daily in combination with:

Nab-paclitaxel and gemcitabine
Drug: Gemcitabine
Drug: Ibrutinib
Other Names:
  • IMBRUVICA®
Drug: Nab-paclitaxel
Placebo Comparator: Placebo

Placebo daily in combination with:

Nab-paclitaxel and gemcitabine
Drug: Gemcitabine
Drug: Nab-paclitaxel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Results at an overall median follow-up of 24.87 months
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.
Results at an overall median follow-up of 24.87 months
Overall Survival (OS)
Time Frame: Results at an overall median follow-up of 24.87 months
OS, is defined as the time from date of randomization until date of death from any cause.
Results at an overall median follow-up of 24.87 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Results at an overall median follow-up of 24.87 months
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.
Results at an overall median follow-up of 24.87 months
Overall Response Rate
Time Frame: Results at an overall median follow-up of 24.87 months
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.
Results at an overall median follow-up of 24.87 months
Clinical Benefit Response
Time Frame: Results at an overall median follow-up of 24.87 months

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).
Results at an overall median follow-up of 24.87 months
Carbohydrate Antigen 19-9 (CA19-9) Response
Time Frame: Results at an overall median follow-up of 24.87 months
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.
Results at an overall median follow-up of 24.87 months
Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).
Time Frame: Results at an overall median follow-up of 24.87 months
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.
Results at an overall median follow-up of 24.87 months
Rate of Venous Thromboembolic Events (VTE)
Time Frame: Results at an overall median follow-up of 24.87 months
The VTE rate is defined as percentage of subjects with Venous thromboembolic events (SMQ) per investigator assessment.
Results at an overall median follow-up of 24.87 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pharmacyclics LLC.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: George Cole, MD, Pharmacyclics LLC.

Study record dates

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

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCYC-1137-CA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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

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