The PLATINUM Trial: Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA1/2 or PALB2-Associated Metastatic Pancreatic Cancer

January 6, 2026 updated by: Alliance for Clinical Trials in Oncology

Phase II/III Second-Line NABPLAGEM vs. Nab-Paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Mutant Metastatic Pancreatic Ductal Adenocarcinoma (PLATINUM)

This phase II/III trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel, gemcitabine, plus cisplatin versus the 2-drug chemotherapy combination of nab-paclitaxel plus gemcitabine for the treatment of patients with pancreatic cancer that has spread to other places in the body (metastatic) and a known genetic mutation in the BRCA1, BRCA2, or PALB2 gene.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate and compare overall response rate (ORR) in patients with BRCA1/2 or PALB2 mutant pancreas cancer whose disease has progressed on front-line fluorouracil, irinotecan, leucovorin and oxaliplatin (FOLFIRINOX) treated with nab-paclitaxel, gemcitabine, and cisplatin (NABPLAGEM) = nab-paclitaxel, gemcitabine, and cisplatin (arm 1) versus nab-paclitaxel and gemcitabine (arm 2). (Phase II) II. To evaluate and compare overall survival (OS) time in patients with BRCA1/2 or PALB2 mutant whose disease has progressed on front-line FOLFIRINOX treated with 1) NABPLAGEM = nab-paclitaxel, gemcitabine, and cisplatin (arm 1) versus nab-paclitaxel and gemcitabine (arm 2). (Phase III)

SECONDARY OBJECTIVES:

I. To evaluate and compare progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) criteria between 2 treatment arms.

II. To evaluate and compare duration of response (DoR) between 2 treatment arms.

III. To evaluate and compare CA19-9 response (defined as patients with a baseline CA19-9 >= 2x upper limit of normal (ULN) who demonstrate a minimum 25% decrease in CA19-9 at any time point) between 2 treatment arms.

IV. To evaluate and compare toxicity profile as assessed by treating clinicians between 2 treatment arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive nab-paclitaxel intravenously (IV) over 30-40 minutes, gemcitabine IV over 30-40 minutes, and cisplatin IV over 30-60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI) or computed tomography (CT) throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.

ARM II: Patients receive nab-paclitaxel IV over 30-40 minutes and gemcitabine IV over 30-40 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.

After completion of study treatment, patients are followed up within 30 days and then every 3 months for 2 years or until death, whichever comes first.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 98508
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, United States, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, United States, 99508
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, United States, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, United States, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, United States, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
      • Anchorage, Alaska, United States, 99504
        • Anchorage Radiation Therapy Center
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • CTCA at Western Regional Medical Center
      • Phoenix, Arizona, United States, 85004
        • Cancer Center at Saint Joseph's
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
    • California
      • Arroyo Grande, California, United States, 93420
        • Mission Hope Medical Oncology - Arroyo Grande
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Carmichael, California, United States, 95608
        • Mercy San Juan Medical Center
      • Carmichael, California, United States, 95608
        • Mercy Cancer Center - Carmichael
      • Elk Grove, California, United States, 95758
        • Mercy Cancer Center - Elk Grove
      • Irvine, California, United States, 92612
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • Laguna Hills, California, United States, 92653
        • Uci Health Laguna Hills
      • Merced, California, United States, 95340
        • Mercy Cancer Center
      • Napa, California, United States, 94558
        • Providence Queen of The Valley
      • Orange, California, United States, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Rocklin, California, United States, 95765
        • Mercy Cancer Center - Rocklin
      • Sacramento, California, United States, 95816
        • Mercy Cancer Center - Sacramento
      • San Diego, California, United States, 92103
        • UC San Diego Medical Center - Hillcrest
      • San Francisco, California, United States, 94158
        • UCSF Medical Center-Mission Bay
      • San Luis Obispo, California, United States, 93401
        • Pacific Central Coast Health Center-San Luis Obispo
      • Santa Maria, California, United States, 93444
        • Mission Hope Medical Oncology - Santa Maria
      • Santa Rosa, California, United States, 95403
        • Providence Medical Foundation - Santa Rosa
      • Santa Rosa, California, United States, 95405
        • Providence Santa Rosa Memorial Hospital
      • Stockton, California, United States, 95204
        • Saint Joseph's Medical Center
      • Woodland, California, United States, 95695
        • Woodland Memorial Hospital
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, United States, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • Colorado Springs, Colorado, United States, 80923
        • Saint Francis Cancer Center
      • Durango, Colorado, United States, 81301
        • Mercy Medical Center
      • Durango, Colorado, United States, 81301
        • CommonSpirit Cancer Center Mercy
      • Lakewood, Colorado, United States, 80228
        • Saint Anthony Hospital
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
      • Westminster, Colorado, United States, 80023
        • Saint Anthony North Hospital
    • Florida
      • Aventura, Florida, United States, 33180
        • Mount Sinai Comprehensive Cancer Center at Aventura
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer and Blood Center LLC
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96817
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, United States, 96813
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96817
        • Kuakini Medical Center
      • Honolulu, Hawaii, United States, 96817
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Diagnostic Radiology Services LLC
      • Kahului, Hawaii, United States, 96732
        • Straub Medical Center - Kahului Clinic
      • Kailua, Hawaii, United States, 96734
        • Castle Medical Center
      • Lihue, Hawaii, United States, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
      • ‘Aiea, Hawaii, United States, 96701
        • Hawaii Cancer Care - Westridge
      • ‘Aiea, Hawaii, United States, 96701
        • Pali Momi Medical Center
      • ‘Aiea, Hawaii, United States, 96701
        • Queen's Cancer Center - Pearlridge
      • ‘Aiea, Hawaii, United States, 96701
        • The Cancer Center of Hawaii-Pali Momi
      • ‘Ewa Beach, Hawaii, United States, 96706
        • The Queen's Medical Center - West Oahu
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, United States, 83712
        • Saint Luke's Cancer Institute - Boise
      • Caldwell, Idaho, United States, 83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Health - Coeur d'Alene
      • Emmett, Idaho, United States, 83617
        • Walter Knox Memorial Hospital
      • Fruitland, Idaho, United States, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Idaho Urologic Institute-Meridian
      • Meridian, Idaho, United States, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Nampa, Idaho, United States, 83687
        • Saint Luke's Cancer Institute - Nampa
      • Post Falls, Idaho, United States, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint, Idaho, United States, 83864
        • Kootenai Clinic Cancer Services - Sandpoint
      • Twin Falls, Idaho, United States, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Rush-Copley Medical Center
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, United States, 62902
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, United States, 62918
        • SIH Cancer Institute
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, United States, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, United States, 60612
        • University of Illinois
      • Danville, Illinois, United States, 61832
        • Carle at The Riverfront
      • DeKalb, Illinois, United States, 60115
        • Northwestern Medicine Cancer Center Kishwaukee
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Dixon, Illinois, United States, 61021
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, United States, 62401
        • Carle Physician Group-Effingham
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, United States, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Geneva, Illinois, United States, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Glenview, Illinois, United States, 60026
        • Northwestern Medicine Glenview Outpatient Center
      • Grayslake, Illinois, United States, 60030
        • Northwestern Medicine Grayslake Outpatient Center
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Lake Forest, Illinois, United States, 60045
        • Northwestern Medicine Lake Forest Hospital
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, United States, 61938
        • Carle Physician Group-Mattoon/Charleston
      • New Lenox, Illinois, United States, 60451
        • UC Comprehensive Cancer Center at Silver Cross
      • O'Fallon, Illinois, United States, 62269
        • Cancer Care Center of O'Fallon
      • O'Fallon, Illinois, United States, 62269
        • HSHS Saint Elizabeth's Hospital
      • Oak Brook, Illinois, United States, 60523
        • Northwestern Medicine Oak Brook
      • Orland Park, Illinois, United States, 60462
        • University of Chicago Medicine-Orland Park
      • Orland Park, Illinois, United States, 60462
        • Northwestern Medicine Orland Park
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, United States, 61354
        • Valley Radiation Oncology
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
      • Springfield, Illinois, United States, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Warrenville, Illinois, United States, 60555
        • Northwestern Medicine Cancer Center Warrenville
      • Washington, Illinois, United States, 61571
        • Illinois CancerCare - Washington
      • Yorkville, Illinois, United States, 60560
        • Rush-Copley Healthcare Center
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Northwest Cancer Center - Main Campus
      • Crown Point, Indiana, United States, 46307
        • UChicago Medicine Northwest Indiana
      • Dyer, Indiana, United States, 46311
        • Northwest Oncology LLC
      • Hobart, Indiana, United States, 46342
        • Northwest Cancer Center - Hobart
      • Hobart, Indiana, United States, 46342
        • Saint Mary Medical Center
      • Indianapolis, Indiana, United States, 46312
        • Saint Catherine Hospital
      • Munster, Indiana, United States, 46321
        • The Community Hospital
      • Munster, Indiana, United States, 46321
        • Women's Diagnostic Center - Munster
      • Valparaiso, Indiana, United States, 46383
        • Northwest Cancer Center - Valparaiso
    • Iowa
      • Ames, Iowa, United States, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, United States, 50010
        • McFarland Clinic - Ames
      • Ankeny, Iowa, United States, 50023
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
      • Boone, Iowa, United States, 50036
        • McFarland Clinic - Boone
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates at Mercy Medical Center
      • Clive, Iowa, United States, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, United States, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Council Bluffs, Iowa, United States, 51503
        • Alegent Health Mercy Hospital
      • Council Bluffs, Iowa, United States, 51503
        • Heartland Oncology and Hematology LLP
      • Council Bluffs, Iowa, United States, 51503
        • Methodist Jennie Edmundson Hospital
      • Creston, Iowa, United States, 50801
        • Greater Regional Medical Center
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Des Moines, Iowa, United States, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Fort Dodge, Iowa, United States, 50501
        • McFarland Clinic - Trinity Cancer Center
      • Jefferson, Iowa, United States, 50129
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, United States, 50158
        • McFarland Clinic - Marshalltown
      • Waukee, Iowa, United States, 50263
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
      • West Des Moines, Iowa, United States, 50266
        • Mercy Medical Center-West Lakes
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Flaget Memorial Hospital
      • Corbin, Kentucky, United States, 40701
        • Commonwealth Cancer Center-Corbin
      • Lexington, Kentucky, United States, 40504
        • Saint Joseph Radiation Oncology Resource Center
      • Lexington, Kentucky, United States, 40509
        • Saint Joseph Hospital East
      • Lexington, Kentucky, United States, 40504
        • Saint Joseph Hospital
      • London, Kentucky, United States, 40741
        • Saint Joseph London
      • Mount Sterling, Kentucky, United States, 40353
        • Saint Joseph Mount Sterling
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Rogel Cancer Center
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek
      • Brighton, Michigan, United States, 48116
        • University of Michigan - Brighton Center for Specialty Care
      • Brownstown, Michigan, United States, 48183
        • Henry Ford Cancer Institute-Downriver
      • Clinton Township, Michigan, United States, 48038
        • Henry Ford Macomb Hospital-Clinton Township
      • Dearborn, Michigan, United States, 48126
        • Henry Ford Medical Center-Fairlane
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49009
        • Beacon Kalamazoo Cancer Center
      • Kalamazoo, Michigan, United States, 49048
        • Beacon Kalamazoo
      • Monroe, Michigan, United States, 48162
        • Toledo Clinic Cancer Centers-Monroe
      • Muskegon, Michigan, United States, 49444
        • Trinity Health Muskegon Hospital
      • Niles, Michigan, United States, 49120
        • Corewell Health Lakeland Hospitals - Niles Hospital
      • Norton Shores, Michigan, United States, 49444
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Novi, Michigan, United States, 48377
        • Henry Ford Medical Center-Columbus
      • Reed City, Michigan, United States, 49677
        • Corewell Health Reed City Hospital
      • Saint Joseph, Michigan, United States, 49085
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
      • Saint Joseph, Michigan, United States, 49085
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • West Bloomfield, Michigan, United States, 48322
        • Henry Ford West Bloomfield Hospital
      • Wyandotte, Michigan, United States, 48192
        • Henry Ford Wyandotte Hospital
      • Wyoming, Michigan, United States, 49519
        • University of Michigan Health - West
    • Minnesota
      • Aitkin, Minnesota, United States, 56431
        • Riverwood Healthcare Center
      • Baxter, Minnesota, United States, 56425
        • Essentia Health - Baxter Clinic
      • Brainerd, Minnesota, United States, 56401
        • Essentia Health Saint Joseph's Medical Center
      • Burnsville, Minnesota, United States, 55337
        • Minnesota Oncology - Burnsville
      • Cambridge, Minnesota, United States, 55008
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Crosslake, Minnesota, United States, 56442
        • Essentia Health - Saint Joseph's Crosslake Clinic
      • Deer River, Minnesota, United States, 56636
        • Essentia Health - Deer River Clinic
      • Detroit Lakes, Minnesota, United States, 56501
        • Essentia Health Saint Mary's - Detroit Lakes Clinic
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Cancer Center
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, United States, 55805
        • Miller-Dwan Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Ely, Minnesota, United States, 55731
        • Essentia Health - Ely Clinic
      • Fosston, Minnesota, United States, 56542
        • Essentia Health - Fosston
      • Hibbing, Minnesota, United States, 55746
        • Essentia Health Hibbing Clinic
      • International Falls, Minnesota, United States, 56649
        • Essentia Health - International Falls Clinic
      • Maple Grove, Minnesota, United States, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55454
        • Health Partners Inc
      • Monticello, Minnesota, United States, 55362
        • Monticello Cancer Center
      • Moose Lake, Minnesota, United States, 55767
        • Essentia Health - Moose Lake Clinic
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • Park Rapids, Minnesota, United States, 56470
        • Essentia Health - Park Rapids
      • Pequot Lakes, Minnesota, United States, 56472
        • Essentia Health - Saint Joseph's Pequot Lakes Clinic
      • Pine River, Minnesota, United States, 56474
        • Essentia Health - Saint Joseph's Pine River Clinic
      • Princeton, Minnesota, United States, 55371
        • Fairview Northland Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Sandstone, Minnesota, United States, 55072
        • Essentia Health Sandstone
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Staples, Minnesota, United States, 56479
        • Essentia Health - Saint Joseph's Staples Clinic
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Virginia, Minnesota, United States, 55792
        • Essentia Health Virginia Clinic
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, United States, 55092
        • Fairview Lakes Medical Center
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
      • Grenada, Mississippi, United States, 38901
        • Baptist Cancer Center-Grenada
      • New Albany, Mississippi, United States, 38652
        • Baptist Memorial Hospital and Cancer Center-Union County
      • Oxford, Mississippi, United States, 38655
        • Baptist Memorial Hospital and Cancer Center-Oxford
      • Southhaven, Mississippi, United States, 38671
        • Baptist Memorial Hospital and Cancer Center-Desoto
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, United States, 63703
        • Mercy Cancer Center - Cape Girardeau
      • Farmington, Missouri, United States, 63640
        • Parkland Health Center - Farmington
      • Sainte Genevieve, Missouri, United States, 63670
        • Sainte Genevieve County Memorial Hospital
      • St Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • Sullivan, Missouri, United States, 63080
        • Missouri Baptist Sullivan Hospital
      • Sunset Hills, Missouri, United States, 63127
        • BJC Outpatient Center at Sunset Hills
    • Montana
      • Anaconda, Montana, United States, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Health Deaconess Hospital
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
      • Great Falls, Montana, United States, 59405
        • Benefis Sletten Cancer Institute
      • Havre, Montana, United States, 59501
        • Hi-Line Sletten Cancer Center
      • Kalispell, Montana, United States, 59901
        • Logan Health Medical Center
      • Missoula, Montana, United States, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, United States, 59804
        • Community Medical Center
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • CHI Health Saint Francis
      • Kearney, Nebraska, United States, 68847
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, United States, 68510
        • Saint Elizabeth Regional Medical Center
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, United States, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, United States, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, United States, 68130
        • Alegent Health Lakeside Hospital
      • Omaha, Nebraska, United States, 68131
        • Creighton University Medical Center
      • Omaha, Nebraska, United States, 68114
        • Oncology Associates PC
      • Omaha, Nebraska, United States, 68114
        • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
      • Papillion, Nebraska, United States, 68046
        • Midlands Community Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
      • Nashua, New Hampshire, United States, 03063
        • Dartmouth Cancer Center - Nashua
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
    • New York
      • Glens Falls, New York, United States, 12801
        • Glens Falls Hospital
      • Mineola, New York, United States, 11501
        • NYU Langone Hospital - Long Island
      • New York, New York, United States, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Essentia Health Cancer Center-South University Clinic
      • Jamestown, North Dakota, United States, 58401
        • Essentia Health - Jamestown Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, United States, 45247
        • TriHealth Cancer Institute-Westside
      • Cincinnati, Ohio, United States, 45255
        • TriHealth Cancer Institute-Anderson
      • Maumee, Ohio, United States, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Centers-Toledo
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Baker City, Oregon, United States, 97814
        • Saint Alphonsus Cancer Care Center-Baker City
      • Bend, Oregon, United States, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, United States, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, United States, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, United States, 97420
        • Bay Area Hospital
      • Hood River, Oregon, United States, 97031
        • Providence Hood River Memorial Hospital
      • Newberg, Oregon, United States, 97132
        • Providence Newberg Medical Center
      • Ontario, Oregon, United States, 97914
        • Saint Alphonsus Cancer Care Center-Ontario
      • Oregon City, Oregon, United States, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
      • Redmond, Oregon, United States, 97756
        • Saint Charles Health System-Redmond
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Roper Hospital
      • Charleston, South Carolina, United States, 29414
        • Bon Secours Saint Francis Hospital
      • Charleston, South Carolina, United States, 29403
        • Charleston Oncology - Roper
      • Charleston, South Carolina, United States, 29414
        • Charleston Oncology - Saint Francis
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Baptist Memorial Hospital and Cancer Center-Collierville
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, United States, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Dallas, Texas, United States, 75237
        • UT Southwestern Simmons Cancer Center - RedBird
      • Fort Worth, Texas, United States, 76104
        • UT Southwestern/Simmons Cancer Center-Fort Worth
      • Richardson, Texas, United States, 75080
        • UT Southwestern Clinical Center at Richardson/Plano
    • Vermont
      • Saint Johnsbury, Vermont, United States, 05819
        • Dartmouth Cancer Center - North
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute
      • Fairfax, Virginia, United States, 22033
        • Inova Fair Oaks Hospital
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Providence Regional Cancer System-Aberdeen
      • Bellingham, Washington, United States, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, United States, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, United States, 98026
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, United States, 98029
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, United States, 98503
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, United States, 98632
        • PeaceHealth Saint John Medical Center
      • Mount Vernon, Washington, United States, 98274
        • Skagit Regional Health Cancer Care Center
      • Seattle, Washington, United States, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, United States, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Sedro-Woolley, Washington, United States, 98284
        • PeaceHealth United General Medical Center
      • Shelton, Washington, United States, 98584
        • Providence Regional Cancer System-Shelton
      • Silverdale, Washington, United States, 98383
        • Saint Michael Cancer Center
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest - Spokane South
      • Spokane, Washington, United States, 99216
        • Cancer Care Northwest-Valley
      • Spokane, Washington, United States, 99218
        • Cancer Care Northwest-North Spokane
      • Vancouver, Washington, United States, 98664
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, United States, 99362
        • Providence Saint Mary Regional Cancer Center
      • Yelm, Washington, United States, 98597
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • Ashland, Wisconsin, United States, 54806
        • Duluth Clinic Ashland
      • Ashland, Wisconsin, United States, 54806
        • Northwest Wisconsin Cancer Center
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Hayward, Wisconsin, United States, 54843
        • Essentia Health-Hayward Clinic
      • Hayward, Wisconsin, United States, 54843
        • Tamarack Health Hayward Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Medical Center - Minocqua
      • New Richmond, Wisconsin, United States, 54017
        • Cancer Center of Western Wisconsin
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Spooner, Wisconsin, United States, 54801
        • Essentia Health-Spooner Clinic
      • Stevens Point, Wisconsin, United States, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Superior, Wisconsin, United States, 54880
        • Essentia Health Saint Mary's Hospital - Superior
      • Weston, Wisconsin, United States, 54476
        • Marshfield Medical Center - Weston
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Memorial Hospital of Laramie County
      • Cody, Wyoming, United States, 82414
        • Billings Clinic-Cody
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Metastatic pancreatic adenocarcinoma. Adenosquamous carcinoma, squamous carcinoma, acinar cell carcinoma, and carcinoma not otherwise specified are also acceptable
  • BRCA1/2 or PALB2 mutation (somatic or germline) identified on any Clinical Laboratory Improvement Amendments (CLIA)-certified gene panel. Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org. (Submission of mutation report will be required)
  • Measurable disease
  • Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment

  • Clinical or radiographic progression on first-line FOLFIRINOX (or nanoliposomal irinotecan, fluorouracil, leucovorin, and oxaliplatin [NALIRIFOX]) for metastatic disease

    • Patients whose front-line chemotherapy was required to be simplified due to toxicity associated with any of the constituent components of FOLFIRINOX/NALIRIFOX (e.g. simplified to leucovorin calcium, fluorouracil, and oxaliplatin [FOLFOX], leucovorin calcium, fluorouracil, and irinotecan [FOLFIRI], fluorouracil [5-FU] [including capecitabine]) will be eligible
    • Patients with progressive disease while on maintenance PARP inhibitor treatment after FOLFIRINOX (or NALIRIFOX), irrespective of how long ago they received FOLFIRINOX/NALIRIFOX, will also be eligible
    • Patients who develop metastatic disease during or within 6 months after completing FOLFIRINOX/NALIRIFOX in either the locally advanced or adjuvant/neoadjuvant settings will be eligible

  • Patients may not have received prior cisplatin for their pancreatic cancer in any setting

    * Note: Patients may have previously received gemcitabine +/- nab-paclitaxel for resectable (neoadjuvant/adjuvant) or locally advanced disease if (1) treatment was completed > 1 year ago and (2) in the opinion of the treating provider, re-treatment with gemcitabine/nab-paclitaxel is appropriate

  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky performance status >= 60)
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 8.0 g/dL
  • Creatinine =< 1.8 x institutional upper limit of normal (ULN) or calculated creatinine clearance (Calc. CrCl) > 40 mL/min

  • Total bilirubin =< 2.0 x institutional ULN

    * Any elevated bilirubin should be asymptomatic at enrollment (except for participants with documented Gilbert's syndrome who may only be included if the total bilirubin =< 3 x ULN or direct bilirubin =< 1.5 x ULN)

  • Aspartate transaminase (AST)/alanine transaminase (ALT) =< 3 x institutional ULN

    * AST/ALT of =< 5 x ULN if liver metastases are present

  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects

    * Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required

  • Patients with > grade 2 peripheral sensory neuropathy are not eligible
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 8-weeks.

    * Patients with known, new or progressive brain metastases (active brain metastases) or leptomeningeal disease are ineligible

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load anytime within 6 months prior to registration are eligible for this trial

  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

    * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

  • Concomitant chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
  • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (nab-paclitaxel, gemcitabine, cisplatin)
Patients receive nab-paclitaxel IV over 30-40 minutes, gemcitabine IV over 30-40 minutes, and cisplatin IV over 30-60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
Drug: Cisplatin
Given IV
Drug: Gemcitabine
Given IV
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CAT Scan
  • CT Scan
Procedure: Biospecimen Collection
Undergo blood sample collection
Drug: Nab paclitaxel
Given IV
Other Names:
  • ABI-007
  • Abraxane
  • Albumin-bound Paclitaxel
  • Protein-bound Paclitaxel
Active Comparator: Arm II (nab-paclitaxel, gemcitabine)
Patients receive nab-paclitaxel IV over 30-40 minutes and gemcitabine IV over 30-40 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
Drug: Gemcitabine
Given IV
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CAT Scan
  • CT Scan
Procedure: Biospecimen Collection
Undergo blood sample collection
Drug: Nab paclitaxel
Given IV
Other Names:
  • ABI-007
  • Abraxane
  • Albumin-bound Paclitaxel
  • Protein-bound Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) (Phase II)
Time Frame: Up to 12 months
Will be assessed by the proportion of patients who achieve complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) during the protocol treatment. Fisher's exact test will be conducted based on the first 32 patients in each arm who meet PP population criteria.
Up to 12 months
Overall Survival (OS) (Phase III)
Time Frame: From the date of randomization to the date of death due to all causes, assessed up to 5 years
Will be conducted on modified intention-to-treat population. Stratified Cox model will be constructed to compare OS in the experimental arm to OS in the control arm.
From the date of randomization to the date of death due to all causes, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: From the date of randomization to the date of first documented disease progression or death due to all causes, whichever occurs first, assessed up to 5 years
Will be assessed per RECIST 1.1. Will be estimated, in each arm, using the method of Kaplan-Meier and compared by stratified Cox regression model.
From the date of randomization to the date of first documented disease progression or death due to all causes, whichever occurs first, assessed up to 5 years
Incidence of adverse events
Time Frame: Up to 30 days after the last dose of study treatment
The maximum grade for each type of adverse events that are possibly, probably, or definitely related to study treatments will be recorded for each patient.
Up to 30 days after the last dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2024

Primary Completion (Estimated)

January 15, 2029

Study Completion (Estimated)

December 9, 2029

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A022106
  • NCI-2023-06547 (Other Identifier: NCI Clinical Trial Reporting Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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