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
| Autor: | Susie Cooke, T.R. Jeffry Evans, Derek Grose, Sumitra Mohan, David K. Chang, Janet Graham, Juan W. Valle, Judith Dixon-Hughes, Hannah K. Weir, Andrew V. Biankin, James Paul, Jamie Stobo |
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| Rok vydání: | 2018 |
| Předmět: |
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 |
| Zdroj: | Journal of Clinical Oncology. 36:TPS4158-TPS4158 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2018.36.15_suppl.tps4158 |
| Popis: | 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... |
| Databáze: | OpenAIRE |
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