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PRIMUS-001: An adaptive phase II study of FOLFOX-A (FOLFOX and nab-paclitaxel) versus AG (nab-paclitaxel and gemcitabine) in patients with metastatic pancreatic cancer, with integrated biomarker evaluation (ISRCTN75002153) – Part of Precision-Panc
- Source :
- Journal of Clinical Oncology. 36:TPS4158-TPS4158
- Publication Year :
- 2018
- Publisher :
- American Society of Clinical Oncology (ASCO), 2018.
-
Abstract
- TPS4158Background: Platinum-containing regimens (e.g. FOLFIRINOX) have shown survival benefit for pancreatic cancer (PC), with some “exceptional responders”; biomarkers (BM) of response are not well defined. Tumors with mutations in BRCA1/2 and other Fanconi Anemia genes, are preferentially sensitive to DNA-damaging agents (e.g. platinum) through synthetic lethality mechanisms, as they are defective in DNA damage response (DDR). We have shown that DDR deficiency may be present in 20% of PC. PRIMUS-001 aims to exploit defective DDR as a therapeutic vulnerability, with integrated study of BM of DNA-damaging agent response. Methods: PRIMUS-001 will enroll patients who are profiled molecularly using Precision-Panc NGS Diagnostic (BM via bespoke clinical grade assay). It is a multicentre, randomized (1:1), open-label, phase II trial comparing FOLFOX-A (nab-paclitaxel 150mg/m2 IV, oxaliplatin 85mg/m2, folinic acid 350mg flat dose, fluorouracil infusion 2400mg/m2 continuous IV infusion) vs AG (nab-paclitaxel 125...
- Subjects :
- 0301 basic medicine
Cancer Research
FOLFIRINOX
business.industry
Phases of clinical research
medicine.disease
Gemcitabine
Oxaliplatin
03 medical and health sciences
Folinic acid
030104 developmental biology
0302 clinical medicine
Oncology
FOLFOX
Fluorouracil
030220 oncology & carcinogenesis
Pancreatic cancer
medicine
Cancer research
business
medicine.drug
Subjects
Details
- ISSN :
- 15277755 and 0732183X
- Volume :
- 36
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Oncology
- Accession number :
- edsair.doi...........9cf4e529a3124ff3db2d628e15b313e4