AzTrials
AzTrials

Metastatic Pancreatic AdenocarcinomaPhase 3NCT02436668

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

A Phase 3 study testing Ibrutinib, Gemcitabine and Nab-paclitaxel in people with Metastatic Pancreatic Adenocarcinoma, run by Pharmacyclics LLC. at 86 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Adenocarcinoma
What is being tested?
Ibrutinib, Gemcitabine and Nab-paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
430 participants
Where
86 sitesin 8 countries
Study dates
May 2015to 25 Apr 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

86 sites in 8 countries.

86 sites in 8 countries

United States28 sites

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607

  • Arizona Center for Cancer Care

    Avondale, Arizona, 85323

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70809

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Bethesda Memorial Hospital

    Boynton Beach, Florida, 33425

  • The Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • Saint Joseph Mercy Health System

    Chelsea, Michigan, 48118

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • St. Mary's Medical Center

    Daly City, California, 94015

  • Ingalls Memorial Hospital Cancer Research Center

    Harvey, Illinois, 64026

  • Penn State University Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Oncology Specialties, PC; Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • Investigative Clinical Research of Indiana

    Indianapolis, Indiana, 46260

  • Joliet Oncology-Hematology Associates, LTD

    Joliet, Illinois, 60435

  • Moores UCSD Cancer Center

    La Jolla, California, 92093

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Northwest Georgia Oncology Centers, PC

    Marietta, Georgia, 30060

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Eastern Connecticut Hematology/Oncology Assoc.

    Norwich, Connecticut, 06360

  • Nebraska Medicine - Peggy D. Cowdery Patient Care Center

    Omaha, Nebraska, 68198

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

    Pittsfield, Massachusetts, 01201

  • Gibbs Cancer Center

    Spartanburg, South Carolina, 29303

  • MultiCare Health System Institute for Research and Innovation

    Tacoma, Washington, 98405

  • Florida Hospital Tampa

    Tampa, Florida, 33613

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington, 98801

Other trials in United States

France11 sites

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, Doubs, 25030

  • Groupe Hospitalier Saint André - Hôpital Saint André

    Bordeaux, Gironde, 33000

  • Centre Georges François Leclerc

    Dijon, Côte-d'Or, 21079

  • Hôpital Nord Franche Comté

    Doubs, Montbeliard, 25209

  • Hôpital de la Timone

    Marseille, Bouches-du-Rhône, 13385

  • Centre Antoine Lacassagne

    Nice, Alpes Maritimes, 06189

  • Hôpital Saint-Antoine

    Paris, Paris, 75571

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013

  • CHU Poitiers - Hôpital la Milétrie

    Poitiers, Vienne, 86021

  • Centre Paul Strauss

    Strasbourg, Bas Rhin, 67091

  • CHU de Toulouse - Hôpital Rangueil

    Toulouse, Haute Garonne, 31059

Other trials in France

Italy10 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Ancona

  • Azienda Ospedaliero Universitaria San Martino

    Genova, 16132

  • Ospedale San Raffaele

    Milan, 20132

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

  • Azienda Ospedaliera Ospedale Niguarda Ca' Granda

    Milan, 20162

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

Other trials in Italy

Spain10 sites

  • Hospital del Mar

    Barcelona, 08003

  • Specialist

    Barcelona, 08006

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • ICO l´Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

South Korea8 sites

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

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

    Seoul, 06591

  • Korea University Guro Hospital

    Seoul, 152-703

Other trials in South Korea

Germany7 sites

  • Onkologische Schwerpunktpraxis Kurfuerstendamm

    Berlin, 10707

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia, 50937

  • Gemeinschaftspraxis Haematologie und Onkologie

    Dresden, Saxony-Anhalt, 01307

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Leipzig AoeR

    Leipzig, Saxony, 04103

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89070

Other trials in Germany

United Kingdom7 sites

  • Broomfield Hospital

    Chelmsford, Essex, CM1 7ET

  • The Clatterbridge Cancer Centre

    Liverpool, Merseyside, L7 8XP

  • Royal Free Hospital

    London, NW3 2QG

  • The Christie

    Manchester, Greater Manchester, M20 4BX

  • Derriford Hospital

    Plymouth, Devon, PL6 8BQ

  • Southampton General Hospital

    Southampton, Hampshire, SO16 6YD

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Belgium5 sites

  • ULB Hôpital Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Grand Hôpital de Charleroi

    Gilly, 6060

  • UZ Leuven

    Leuven, 3000

  • C. H. U. Sart Tilman

    Liège, 4000

Other trials in Belgium

About this study

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

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02436668
Study groupRoleWhat they receive
IbrutinibActive comparatorIbrutinib daily in combination with: Nab-paclitaxel and gemcitabine
Receives: Drug: Ibrutinib; Drug: Gemcitabine; Drug: Nab-paclitaxel
PlaceboPlacebo comparatorPlacebo daily in combination with: Nab-paclitaxel and gemcitabine
Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Results at an overall median follow-up of 24.87 months

  2. Overall Survival (OS)

    OS, is defined as the time from date of randomization until date of death from any cause.

    Measured: Results at an overall median follow-up of 24.87 months

Secondary outcomes (6)

  1. 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.

    Measured: Results at an overall median follow-up of 24.87 months

  2. 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.

    Measured: Results at an overall median follow-up of 24.87 months

  3. 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).

    Measured: Results at an overall median follow-up of 24.87 months

  4. 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.

    Measured: Results at an overall median follow-up of 24.87 months

  5. 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.

    Measured: Results at an overall median follow-up of 24.87 months

  6. Rate of Venous Thromboembolic Events (VTE)

    The VTE rate is defined as percentage of subjects with Venous thromboembolic events (SMQ) per investigator assessment.

    Measured: Results at an overall median follow-up of 24.87 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionOct 2018
  4. Study completion25 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
430 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02436668
Sponsor's protocol ID
PCYC-1137-CA
Status last verified
Dec 2020
First submitted
4 May 2015
Last updated
30 Dec 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibrutinib, Gemcitabine and Nab-paclitaxel in people with Metastatic Pancreatic Adenocarcinoma, run by Pharmacyclics LLC. at 86 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, France, Italy, Spain, South Korea and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Results at an overall median follow-up of 24.87 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02436668.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in