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Onivyde pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion

DRUG10 trials

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
Groupe Belge D'Oncologie DigestiveMETASTATIC PANCREATIC DUCTAL ADENOCARCINOMA
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
University Of CologneHepatic Oligometastatic Adenocarcinoma of the Pancreas
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
Medica Scientia Innovation Research S.L.HER2 negative metastatic breast cancer (MBC) with nervous system involvement and measurable metastases
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
Fondation Franc.Cancerologie DigestiveMetastatic pancreatic cancer
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
Amsterdam UMCpreviously untreated metastatic or locally advanced esophagogastric cancer
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
Amsterdam UMCmetastatic pancreatic cancer
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
Association GercorPatients with metastatic pancreatic ductal adenocarcinoma.
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
Heinrich-Heine-Universitaet Duesseldorfadvanced, non resectable or metastatic cholangio- or gallbladder carcinoma after failure to respond to a previous gemcitabine treatment
Start: 2025-10-02Target: 38Updated: 2025-11-10

Phase 3

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