Open AccessRandomized, Multicenter, Phase II Trial of Gemcitabine and Cisplatin With or Without Veliparib in Patients With Pancreas Adenocarcinoma and a Germline BRCA/PALB2 Mutation
Author(s) -
Eileen Mary O'Reilly,
Jonathan W. Lee,
Mark M. Zalupski,
Marinela Capanu,
Jennifer Park,
Talia Golan,
Esther Tahover,
Maeve A. Lowery,
Joanne F. Chou,
Vaibhav Sahai,
Robin Brenner,
Hedy L. Kindler,
Kenneth H. Yu,
Alice Zervoudakis,
Shreya Vemuri,
Zsofia K. Stadler,
K. G. Richard,
Neesha C. Dhani,
Alice Chen,
David P. Kelsen
Publication year - 2020
Publication title -
journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 10.482
H-Index - 548
eISSN - 1527-7755
pISSN - 0732-183X
DOI - 10.1200/jco.19.02931
Subject(s) - medicine , gemcitabine , veliparib , parp inhibitor , pancreatic cancer , clinical endpoint , population , oncology , palb2 , surgery , randomized controlled trial , gastroenterology , cancer , germline mutation , mutation , polymerase , poly adp ribose polymerase , gene , biochemistry , chemistry , environmental health
Five percent to 9% of pancreatic ductal adenocarcinomas (PDACs) develop in patients with a germline BRCA1/2 or PALB2 (g BRCA/PALB2 +) mutation. Phase IB data from a trial that used cisplatin, gemcitabine, and veliparib treatment demonstrated a high response rate (RR), disease control rate (DCR), and overall survival (OS) in this population. We designed an open-label, randomized, multicenter, two-arm phase II trial to investigate cisplatin and gemcitabine with or without veliparib in g BRCA/PALB2 + PDAC.