Pancreatic: Metastatic: 1st Line: NAPOLI 3

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

Title
Ipsen D-US-60010-001 (Pancreatic)
Study Title

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

Site Link
Malignancy
Pancreas Adenocarcinoma
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st
Investigational Agent
Irinotecan liposome injection (Nal-IRI)
Drug Class
Liposomal chemotherapy
PI
Axel Grothey, MD
Sponsor
Ipsen
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically confirmed adenocarcinoma of pancreas not previously treated in metastatic setting
  • Initial diagnosis of metastatic disease < or = 6 weeks prior to screening
  • Measurable disease
  • ECOG PS 0-1
  • Adequate hepatic, hemtologic, and renal function
  • No prior therapy in adjuvant setting unless adjuvant therapy was completed at least 12 months prior to metastatic diagnosis
  • No CNS metastases
Objective
  • Primary- OS
  • Secondary- PFS, ORR
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Adenocarcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X