West Cancer Center

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

Site Link

NCT04083235

Malignancy

Pancreas Adenocarcinoma

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st

Investigational Agent

Irinotecan liposome injection (Nal-IRI)

Drug Class

Liposomal chemotherapy

Axel Grothey, MD

Sponsor

Ipsen

Phase

Phase 3

Status

Open to Enrollment

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

Assessment Frequency Link

Path

Adenocarcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes

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