Product

Irinotecan liposome

Aliases

Irinotecan liposome injection, Onivyde® Reference product, Onivyde Test product

5 clinical trials

3 indications

Indication

Pancreatic Cancer

Indication

Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy

Indication

Small Cell Lung Cancer

Clinical trial

A Phase I, Randomised, Open-Label, Single-Dose, Two-Treatment, Two-Way Crossover, Two-Stage Study to Evaluate the Bioequivalence of Onivyde (Irinotecan Liposome Injection) Manufactured at Two Different Sites Administered in Combination With Anti-Cancer Agents in Adult Participants With Metastatic Pancreatic Adenocarcinoma

Status: Recruiting, Estimated PCD: 2024-05-27

Clinical trial

A Phase I Study to Evaluate the Safety and Tolerability of Irinotecan Liposome in Combination With Oxaliplatin and 5-FU/LV in the Treatment of Advanced Pancreatic Cancer

Status: Active (not recruiting), Estimated PCD: 2023-11-28

Clinical trial

A Randomized, Double-blind, Single-dummy, Parallel-controlled, Multicentre, Phase III Clinical Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy

Status: Completed, Estimated PCD: 2021-11-18

Clinical trial

RESILIENT: A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Progressed on or After Platinum-based First-Line Therapy

Status: Completed, Estimated PCD: 2022-02-08

Clinical trial

NALIRIFOX as Perioperative Treatment in Patients With High-risk Resectable Pancreatic Cancer : a Multicenter, Randomized, Open-label Trial

Status: Not yet recruiting, Estimated PCD: 2025-04-01