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

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Pharmacyclics LLC.
Study ID
NCT02436668
Phase
PHASE3
Status
Completed

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
  • Gemcitabine — DRUG
  • Nab-paclitaxel — DRUG

Study Details

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.

Key Dates

Start date
May 31, 2015
Status verified
Dec 2020
Primary completion
Oct 31, 2018
Completion
Apr 25, 2019

Study Design

Enrollment
430 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ibrutinib
    Ibrutinib daily in combination with: Nab-paclitaxel and gemcitabine
  • Placebo Comparator: Placebo
    Placebo daily in combination with: Nab-paclitaxel and gemcitabine

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Results at an overall median follow-up of 24.87 months ]

Locations (28)

FacilityCityStateZIPSite coordinators
Oncology Specialties, PC; Clearview Cancer InstituteHuntsvilleAlabama35805-
Arizona Center for Cancer CareAvondaleArizona85323-
St. Mary's Medical CenterDaly CityCalifornia94015-
Moores UCSD Cancer CenterLa JollaCalifornia92093-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Norwalk HospitalNorwalkConnecticut06856-
Eastern Connecticut Hematology/Oncology Assoc.NorwichConnecticut06360-
Bethesda Memorial HospitalBoynton BeachFlorida33425-
Florida Hospital TampaTampaFlorida33613-
University Cancer & Blood Center, LLCAthensGeorgia30607-
Northwest Georgia Oncology Centers, PCMariettaGeorgia30060-
Ingalls Memorial Hospital Cancer Research CenterHarveyIllinois64026-
Joliet Oncology-Hematology Associates, LTDJolietIllinois60435-
Investigative Clinical Research of IndianaIndianapolisIndiana46260-
Mary Bird Perkins Cancer CenterBaton RougeLouisiana70809-
Our Lady of the Lake Physician GroupBaton RougeLouisiana70809-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion CenterPittsfieldMassachusetts01201-
Saint Joseph Mercy Health SystemChelseaMichigan48118-
Sparrow Regional Cancer CenterLansingMichigan48912-
Nebraska Medicine - Peggy D. Cowdery Patient Care CenterOmahaNebraska68198-
The Presbyterian HospitalCharlotteNorth Carolina28204-
University of Cincinnati Medical CenterCincinnatiOhio45267-
Penn State University Milton S. Hershey Medical CenterHersheyPennsylvania17033-
Gibbs Cancer CenterSpartanburgSouth Carolina29303-
Scott & White Memorial HospitalTempleTexas76508-
MultiCare Health System Institute for Research and InnovationTacomaWashington98405-
Wenatchee Valley Hospital & ClinicsWenatcheeWashington98801-

Find similar trials in Huntsville, AL

By research site
Oncology Specialties, PC; Clearview Cancer Institute· Huntsville, ALArizona Center for Cancer Care· Avondale, AZSt. Mary's Medical Center· Daly City, CAMoores UCSD Cancer Center· La Jolla, CACedars Sinai Medical Center· Los Angeles, CANorwalk Hospital· Norwalk, CT

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