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

NCT02436668 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: PCYC-1137-CA
• Study Type: interventional
• Target: 430
• Locations: 8 countries
• Sites: 86

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.

Conditions

Metastatic Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  Results at an overall median follow-up of 24.87 months

• Overall Survival (OS)

  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 Outcomes (6)

• 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.

  Results at an overall median follow-up of 24.87 months

• Overall Response Rate

  Results at an overall median follow-up of 24.87 months

• Clinical Benefit Response

  Results at an overall median follow-up of 24.87 months

• Carbohydrate Antigen 19-9 (CA19-9) Response

  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).

  Results at an overall median follow-up of 24.87 months

Study Arms (2)

Ibrutinib

ACTIVE COMPARATOR

Ibrutinib daily in combination with: Nab-paclitaxel and gemcitabine

Drug: Ibrutinib; Drug: Gemcitabine; Drug: Nab-paclitaxel

Placebo

PLACEBO COMPARATOR

Placebo daily in combination with: Nab-paclitaxel and gemcitabine

Drug: Gemcitabine; Drug: Nab-paclitaxel

Interventions

Ibrutinib DRUG

Also known as: IMBRUVICA®

Ibrutinib

Gemcitabine DRUG

Ibrutinib; Placebo

Nab-paclitaxel DRUG

Ibrutinib; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharmacyclics LLC.: lead

Study Sites (86)

Oncology Specialties, PC; Clearview Cancer Institute

Huntsville, Alabama, 35805, United States

Location

Arizona Center for Cancer Care

Avondale, Arizona, 85323, United States

Location

St. Mary's Medical Center

Daly City, California, 94015, United States

Location

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Eastern Connecticut Hematology/Oncology Assoc.

Norwich, Connecticut, 06360, United States

Location

Bethesda Memorial Hospital

Boynton Beach, Florida, 33425, United States

Location

Florida Hospital Tampa

Tampa, Florida, 33613, United States

Location

University Cancer & Blood Center, LLC

Athens, Georgia, 30607, United States

Location

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, 30060, United States

Location

Ingalls Memorial Hospital Cancer Research Center

Harvey, Illinois, 64026, United States

Location

Joliet Oncology-Hematology Associates, LTD

Joliet, Illinois, 60435, United States

Location

Investigative Clinical Research of Indiana

Indianapolis, Indiana, 46260, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Our Lady of the Lake Physician Group

Baton Rouge, Louisiana, 70809, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion Center

Pittsfield, Massachusetts, 01201, United States

Location

Saint Joseph Mercy Health System

Chelsea, Michigan, 48118, United States

Location

Sparrow Regional Cancer Center

Lansing, Michigan, 48912, United States

Location

Nebraska Medicine - Peggy D. Cowdery Patient Care Center

Omaha, Nebraska, 68198, United States

Location

The Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Penn State University Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Gibbs Cancer Center

Spartanburg, South Carolina, 29303, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

MultiCare Health System Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Wenatchee Valley Hospital & Clinics

Wenatchee, Washington, 98801, United States

Location

ULB Hôpital Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Grand Hôpital de Charleroi

Gilly, 6060, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

C. H. U. Sart Tilman

Liège, 4000, Belgium

Location

Centre Antoine Lacassagne

Nice, Alpes Maritimes, 06189, France

Location

Centre Paul Strauss

Strasbourg, Bas Rhin, 67091, France

Location

Hôpital de la Timone

Marseille, Bouches-du-Rhône, 13385, France

Location

Centre Georges François Leclerc

Dijon, Côte-d'Or, 21079, France

Location

CHU Besançon - Hôpital Jean Minjoz

Besançon, Doubs, 25030, France

Location

Groupe Hospitalier Saint André - Hôpital Saint André

Bordeaux, Gironde, 33000, France

Location

CHU de Toulouse - Hôpital Rangueil

Toulouse, Haute Garonne, 31059, France

Location

Hôpital Nord Franche Comté

Doubs, Montbeliard, 25209, France

Location

Hôpital Saint-Antoine

Paris, Paris, 75571, France

Location

CHU Poitiers - Hôpital la Milétrie

Poitiers, Vienne, 86021, France

Location

Groupe Hospitalier Pitie-Salpetriere

Paris, 75013, France

Location

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, 89070, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitaetsklinikum Koeln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitaetsklinikum Leipzig AoeR

Leipzig, Saxony, 04103, Germany

Location

Gemeinschaftspraxis Haematologie und Onkologie

Dresden, Saxony-Anhalt, 01307, Germany

Location

Onkologische Schwerpunktpraxis Kurfuerstendamm

Berlin, 10707, Germany

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti

Ancona, Italy

Location

Azienda Ospedaliero Universitaria San Martino

Genova, 16132, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

IEO Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Azienda Ospedaliera Ospedale Niguarda Ca' Granda

Milan, 20162, Italy

Location

Istituto Nazionale Tumori Fondazione G. Pascale

Napoli, 80131, Italy

Location

IOV - Istituto Oncologico Veneto IRCCS

Padua, 35128, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

ICO l´Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Specialist

Barcelona, 08006, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Derriford Hospital

Plymouth, Devon, PL6 8BQ, United Kingdom

Location

Broomfield Hospital

Chelmsford, Essex, CM1 7ET, United Kingdom

Location

The Christie

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

The Clatterbridge Cancer Centre

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Interventions

ibrutinib; Gemcitabine; 130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: George Cole
• Organization: Pharmacyclics, An AbbVie Company

gcole@pcyc.com

(408) 990-7340

Study Officials

• George Cole, MD

  Pharmacyclics LLC.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 7, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: April 25, 2019
• Last Updated: December 30, 2020
• Results First Posted: November 16, 2020

Record last verified: 2020-12

Locations

FR (11); BE (5); DE (7); ES (10); IT (10); US (28); GB (7); KR (8)