Drugs / 5-fluouracil
last change Sep 2025 re-read 9 days ago

5-fluouracil

also known as 5-fluouracil (5-FU) · 5-FU
Developed for
cancer · malignant pancreatic neoplasm · metastatic neoplasm · pancreatic ductal adenocarcinoma
Investigated by
Servier · Shanghai Henlius Biotech · University of Cologne

Trials 2

20192020202120222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT03577704 Aug 2018 → Sep 2022 cancer Shanghai Henlius Biotech Completed No outcome recorded
Phase 21 trial
Phase 2 NCT04617457 Oct 2021 → Dec 2024 malignant pancreatic neoplasm, metastatic neoplasm University of Cologne Unknown No outcome recorded
Comparator or background therapy3 trials
Phase 2 NCT04469556 Comparator Oct 2020 → Mar 2025 pancreatic ductal adenocarcinoma University Health Network, Toronto Completed No outcome recorded
Phase 2/3 NCT03344068 Background Jan 2018 → Dec 2020 nasopharyngeal carcinoma Sun Yat-sen University Unknown No outcome recorded
Phase 4 NCT01588990 Background Jun 2012 → Sep 2016 colorectal cancer Hoffmann-La Roche Completed No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2017-05-17 Oncolytics Biotech Results Oncolytics Biotech® Announces ASCO Abstracts and Preliminary Data for Studies in Pancreatic and Prostate Cancers oncolyticsbiotech.com ↗
Three of five efficacy evaluable patients showed a tumor response (secondary endpoint), with one having a partial response (six-month duration) and two having stable disease (lasting 126 and 221 days).

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as 5-fluouracil “mFOLFOX6 protocol: oxaliplatin (85 mg/m2), leucovorin (400 mg/m2), and 5-fluouracil (5-FU) (400 mg/m2, followed by 2400 mg/m2), every 2 weeks.” NCT03577704 ↗
4

“Modified FOLFIRINOX (Folinic acid/Leucovorin, 5-Fluouracil, Irinotecan, Oxaliplatin) administered intravenously.” NCT04469556 ↗

“Nedaplatin 80mg/m2 d1+5-fluouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles.” NCT03344068 ↗

NCT04617457 ↗

NCT01588990 ↗

Known as 5-fluouracil (5-FU) “5-fluouracil (5-FU)” NCT04617457 ↗
Known as 5-FU “mFOLFOX6 protocol: oxaliplatin (85 mg/m2), leucovorin (400 mg/m2), and 5-fluouracil (5-FU) (400 mg/m2, followed by 2400 mg/m2), every 2 weeks.” NCT03577704 ↗
Route Intravenous “400 mg/m\^2 IV” NCT01588990 ↗