Drugs / 5-FU/LV
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT03693677 | Nov 2018 → Jan 2025 | malignant pancreatic neoplasm | Federation Francophone de Cancerologie Digestive | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2024-06-04 | Starpharma Pty Ltd | Results DEP irinotecan presentation at ASCO 2024 Annual Meeting starpharma.com ↗
The presentation was part of a rapid oral abstract session and highlighted the final results of the DEP® irinotecan Phase 1/2 clinical trial, which were reported in full last week. |
| 2024-05-27 | Starpharma Pty Ltd | Results Positive final DEP irinotecan Phase 2 clinical trial results starpharma.com ↗ |
| 2023-11-14 | Starpharma Pty Ltd | Results Starpharma Presents at Bell Potter Conference starpharma.com ↗
DCR is 100% and ORR of 20% (cf. published data in advanced CRC patients for conventional irinotecan plus 5-FU/LV (FOLFIRI) as second-line therapy (i.e., in patients less heavily pre-treated than in the current study) reported an ORR of 4%. |
| 2023-10-25 | Starpharma Pty Ltd | Results SPL to present DEP radiotheranostics at Wilsons Conference starpharma.com ↗
DCR is 100% and ORR of 20% (cf. published data in advanced CRC patients for conventional irinotecan plus 5-FU/LV (FOLFIRI) as second-line therapy. |
| 2023-09-12 | Starpharma Pty Ltd | Results Positive DEP irinotecan clinical results presentation starpharma.com ↗
DCR of 100% in CRC patients receiving DEP® irinotecan in combination with 5-fluorouracil (5-FU) and leucovorin (LV), with durable responses of up to 27 weeks to date; |
| 2020-07-01 | Ipsen | Results Ipsen presents Phase I/II clinical data evaluating liposomal irinotecan (Onivyde®) as an investigational first-line combination treatment for metastatic pancreatic cancer at the ESMO World Congress on Gastrointestinal Cancer ipsen.com ↗
The results include safety and efficacy analyses from the multicenter, open-label, study consisting of dose-exploration safety run-in (traditional 3+3 design) to confirm the maximum tolerated dose and appropriate dose regimen for NALIRIFOX in the dose-expansion phase. |
| 2019-07-05 | Ipsen | Results Ipsen and Servier announce initial Phase 1/2 clinical data evaluating liposomal irinotecan (ONIVYDE®) as an investigational first-line treatment for metastatic pancreatic cancer at ESMO 21st World Congress on Gastrointestinal Cancer ipsen.com ↗ |
| 2018-06-22 | Takeda | Results Large-Scale European Review Suggests Disparity in Symptom Recognition and Standardized Treatment for Metastatic Adenocarcinoma of the Pancreas takeda.com ↗
The research suggests that enhanced recognition of symptoms and a standardized treatment approach, especially in the second-line setting, may help improve diagnosis, patient care and outcomes. |
| 2016-10-18 | Takeda | Regulatory Shire Granted EU Marketing Authorization of ONIVYDE®, In Combination With 5-Fluorouracil (5-FU) And Leucovorin (LV), For The Treatment of Metastatic Adenocarcinoma Of The Pancreas in Adult Patients Who Have Progressed Following Gemcitabine-Based Therapy takeda.com ↗
ONIVYDE, in combination with 5- fluorouracil (5-FU) and leucovorin (LV), is the first and only treatment approved for this patient population based on pivotal Phase 3 data (NAPOLI-1) showing increased overall survival i,ii |
| 2014-05-01 | TTY Biopharm | Results 智擎公司宣佈第三期臨床試驗數據顯示MM-398 (PEP02) 加上5-FU/LV合併療法能延長晚期胰臟癌患者的整體存活期 com.tw ↗ |
| 2014-01-18 | Nektar Therapeutics | Results Nektar Presents Positive Clinical Data from a Phase 1 Study of Etirinotecan Pegol (NKTR-102) in Combination with 5-Fluorouracil/Leucovorin at the 2014 Gastrointestinal Cancers Symposium nektar.com ↗
Nektar Therapeutics' (Nasdaq: NKTR) presented favorable data today from a Phase 1 study of etirinotecan pegol (EP, NKTR-102) in combination with 5-fluorouracil (5-FU)/Leucovorin (LV) in patients with advanced cancer. |
All press releases naming this drug 11 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 5-FU/LV | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03693677 ↗ |