Onivyde pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion
Sponsors
AstraZeneca AB, Amsterdam UMC, University Of Cologne, Medica Scientia Innovation Research S.L., Groupe Belge D'Oncologie Digestive
Conditions
Biliary Tract CancerGastric CancerGastroesophageal Junction CancerHER2 negative metastatic breast cancer (MBC) with nervous system involvement and measurable metastasesHepatic Oligometastatic Adenocarcinoma of the PancreasMETASTATIC PANCREATIC DUCTAL ADENOCARCINOMAMetastatic Pancreatic AdenocarcinomaMetastatic pancreatic cancer
Phase 1
Phase 2
“NALPAC” A NON-COMPARATIVE RANDOMIZED PHASE 2 STUDY, EVALUATING THE EFFICACY OF 5-FU + NALIRI AND 5-FU + NALIRINOX FOR METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA (PDAC), PROGRESSIVE AFTER GEMCITABINE-ABRAXANE OR GEMCITABINE MONOTHERAPY.
RecruitingCTIS2024-516336-97-00
Start: 2022-02-21Target: 134Updated: 2025-02-25
Open-Label, Single Arm Phase II Trial Investigating the Efficacy, Safety and Quality of Life of Neoadjuvant Chemotherapy with Liposomal Irinotecan Combined with Oxaliplatin and 5-Fluorouracil/Folinic Acid Followed by Curative Surgical Resection in Patients with Hepatic Oligometastatic Adenocarcinoma of the Pancreas
(HOLIPANC)
SuspendedCTIS2024-512951-18-00
Start: 2021-08-06Target: 150Updated: 2025-07-22
Multicenter open-label, phase II trial, to evaluate the efficacy and safety of nal-IRI for progressing brain metastases in patients with HER2-negative breast cancer.
CompletedCTIS2024-514999-41-00
Start: 2017-04-28End: 2025-04-02Target: 56Updated: 2025-02-06
PRODIGE 61- FFCD 1702 - FUNGEMAX Randomized phase II study comparing 5FU/LV+Nal-IRI, gemcitabine+Nab-paclitaxel or a sequential regimen of 2 months 5FU/LV+Nal-IRI followed by two months of gemcitabine+Nab-paclitaxel, in metastatic pancreatic cancer
Not yet recruitingCTIS2024-518143-38-00
Target: 288Updated: 2025-10-15
Liposomal iRInotecan, Carboplatin or oXaliplatin in the first line treatment of esophagogastric cancer: a randomized phase 2 study (LyRICX)
Active, not recruitingCTIS2023-509287-26-00
Start: 2019-07-01Target: 322Updated: 2025-11-04
A randomized phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy
Active, not recruitingCTIS2023-509463-24-01
Start: 2019-11-04Target: 146Updated: 2025-01-09
Pancreatic cancer first-line NALIRIFOX optimization with 5-FU maintenance and role of antibiotics and microbiota exploration in second-line treatment – A non-comparative, randomized phase II PANORAMIX GERCOR G-116 PRODIGE 105 study
Not yet recruitingCTIS2024-517766-41-00
Target: 142Updated: 2025-05-27
Efficacy and safety of trifluridin/tipiracil in combination with nanoliposomal irinotecan as a second line therapy in patients with cholangiocarcinoma
RecruitingCTIS2024-517330-18-00
Start: 2025-10-02Target: 38Updated: 2025-11-10