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

Completed · Phase 3 · Has a placebo group

Conditions studied: Metastatic Pancreatic Adenocarcinoma

In brief

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 facts

Study ID

NCT02436668

Run by

Pharmacyclics LLC.

People needed

430

Starts

2015-05-01

Expected to finish

2019-04-25

Last updated by the study team

2020-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Arizona Center for Cancer Care — Avondale, Arizona, United States
• St. Mary's Medical Center — Daly City, California, United States
• Moores UCSD Cancer Center — La Jolla, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Norwalk Hospital — Norwalk, Connecticut, United States
• Eastern Connecticut Hematology/Oncology Assoc. — Norwich, Connecticut, United States
• Bethesda Memorial Hospital — Boynton Beach, Florida, United States
• Florida Hospital Tampa — Tampa, Florida, United States
• University Cancer & Blood Center, LLC — Athens, Georgia, United States
• Northwest Georgia Oncology Centers, PC — Marietta, Georgia, United States
• Ingalls Memorial Hospital Cancer Research Center — Harvey, Illinois, United States
• Joliet Oncology-Hematology Associates, LTD — Joliet, Illinois, United States
• Investigative Clinical Research of Indiana — Indianapolis, Indiana, United States
• Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States
• Our Lady of the Lake Physician Group — Baton Rouge, Louisiana, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion Center — Pittsfield, Massachusetts, United States
• Saint Joseph Mercy Health System — Chelsea, Michigan, United States
• Sparrow Regional Cancer Center — Lansing, Michigan, United States
• Nebraska Medicine - Peggy D. Cowdery Patient Care Center — Omaha, Nebraska, United States
• The Presbyterian Hospital — Charlotte, North Carolina, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Penn State University Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Gibbs Cancer Center — Spartanburg, South Carolina, United States
• Oncology Specialties, PC; Clearview Cancer Institute — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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