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



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/12/2018
Start Date:May 2015
End Date:April 2019

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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.


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.
We found this trial at
29
sites
1215 E Michigan Ave
Lansing, Michigan 48912
(517) 364-2890
Principal Investigator: Gordan Srkalovic, MD
Phone: 517-364-2835
Sparrow Regional Cancer Center Sparrow has grown to become the region's largest health system, and...
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Lansing, MI
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
Principal Investigator: Olugbenga Olowokure, MD
Phone: 513-584-2606
University of Cincinnati Medical Center Opening in 1823 as the country
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Andrew Hendifar, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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Athens, Georgia 30607
Principal Investigator: Petros Nikolinakos, MD
Phone: 706-353-2990
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Avondale, Arizona 85323
Principal Investigator: Clarence Adoo, MD
Phone: 602-938-2848
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Baton Rouge, Louisiana 70809
Principal Investigator: David Hanson, MD
Phone: 225-215-1129
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Baton Rouge, Louisiana 70808
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Principal Investigator: Ralph Boccia, MD
Phone: 240-571-2016
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Bethesda, MD
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Boynton Beach, Florida 33425
Principal Investigator: Rogelio Brito, MD
Phone: 561-737-7733
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Bruxelles,
Principal Investigator: Jean-Luc Van Laethem, MD
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200 Hawthorne Ln
Charlotte, North Carolina 28204
(704) 384-4000
Principal Investigator: Justin Favaro, MD
Phone: 704-384-4138
Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
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Chelsea, Michigan 48118
Principal Investigator: Philip Stella, MD
Phone: 734-712-2704
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Daly City, California 94015
Principal Investigator: Robert Weber, MD
Phone: 415-750-4060
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1 Ingalls Drive
Harvey, Illinois 64026
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Hershey, Pennsylvania 17033
Principal Investigator: Nelson Yee, MD
Phone: 717-531-4976
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Huntsville, Alabama 35805
Principal Investigator: Brian Mathews, MD
Phone: 256-705-4283
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Indianapolis, Indiana 46254
Principal Investigator: Robert Manges, MD
Phone: 317-297-2208
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Joliet, Illinois 60435
Principal Investigator: Jason Suh, MD
Phone: 815-730-3098
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La Jolla, California 92093
Principal Investigator: Tony Reid, M.D, PhD
Phone: 858-534-0254
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Marietta, Georgia 30060
Principal Investigator: Hermann Robert, MD
Phone: 770-281-5131
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Norwalk, Connecticut 06856
Principal Investigator: Richard Frank, MD
Phone: 203-852-2996
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Norwich, Connecticut 06360
Principal Investigator: Dinesh Kapur, MD
Phone: 860-886-8362
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687630 Nebraska Medical Ctr
Omaha, Nebraska 68198
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Pittsfield, Massachusetts 01201
Principal Investigator: Michael De Leo, MD
Phone: 413-496-8205
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Spartanburg, South Carolina 29303
Principal Investigator: Caio Rocha-Lima, MD
Phone: 864-560-6810
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Tacoma, Washington 98405
Principal Investigator: John Keech, MD
Phone: 253-697-1201
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Tampa, Florida 33613
Principal Investigator: Sharona Ross, MD
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2401 S. 31st Street
Temple, Texas 76508
254-724-2111
Principal Investigator: Lucas Wong, MD
Phone: 254-724-1291
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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Wenatchee, Washington 98801
Principal Investigator: Lindsay Overton, MD
Phone: 509-665-2315
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