At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma
- ✓Initial metastatic diagnosis ≤6 weeks prior to screening
- ✓≥1 measurable metastatic lesion on CT or MRI (RECIST 1.1)
- ✓ECOG performance status 0 or 1
- ✕Prior chemotherapy, surgery, radiotherapy, or investigational therapy for metastatic pancreatic cancer
- ✕Adjuvant chemotherapy within 12 months of enrollment (or with persistent toxicities)
- ✕Only locally advanced disease (not metastatic)
- ✕Serum albumin <3 g/dL
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas
In Brief
A Phase 3 clinical trial evaluating Irinotecan Liposomal Injection, Oxaliplatin, and 4 other interventions for Metastatic Adenocarcinoma of the Pancreas. Completed, enrolled 770 participants across 200 sites in 18 countries.
Detailed Summary
The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
Study Details
Timeline
Interventions
Irinotecan liposome injection is irinotecan in the form of the sucrosofate salt, encapsulated in liposomes for i.v. infusion. It is supplied in sterile, single-use vials containing 10 mL of irinotecan liposome injection at a concentration of 4.3 mg/mL free base equivalent (FBE).
Oxaliplatin injection, USP is supplied in single-dose vials containing 50 mg, 100 mg or 200 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL.
Fluorouracil injection, USP is a colorless to faint yellow, aqueous, sterile, nonpyrogenic injectable solution available in 50 mL and 100 mL pharmacy bulk package. Each mL contains 50 mg fluorouracil in water for injection, USP.
Leucovorin Calcium for Injection is supplied in vials ranging from 50-500 mg and available as an injectable solution or lyophilized powder for reconstitution.
Nab-paclitaxel is a lyophilised powder containing 100 or 250 mg of paclitaxel formulated as albumin-bound particles in single-use vials for re-constitution. Each mL of the reconstituted formulation will contain 5 mg/mL paclitaxel.
Gemcitabine for injection is a lyophilised powder for solution for infusion, with each single use vial containing 200 mg, 1 g or 2 g of gemcitabine.