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JOURNAL ONKOLOGIE – STUDIE
NAPOLI 3

A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment

Rekrutierend

NCT-Nummer:
NCT04083235

Studienbeginn:
Februar 2020

Letztes Update:
27.07.2021

Wirkstoff:
Irinotecan Liposomal Injection, Oxaliplatin, 5Fluorouracil, Leucovorin, Nab-Paclitaxel, Gemcitabine

Indikation (Clinical Trials):
Adenocarcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Ipsen

Collaborator:
-

Studienleiter

Ipsen Medical Director
Study Director
Ipsen

Kontakt

Studienlocations
(3 von 245)

Charité - Universitaetsmedizin Berlin
10117 Berlin
(Berlin)
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St. Josef-Hospital
44791 Bochum
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Klinikum Esslingen GmbH
73730 Esslingen
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Onkologisches Zentrum Krankenhaus Nordwest
Steinbacher Hohl 2-26
60488 Frankfurt am Main
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06108 Halle
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Martin Luther Universitat Halle-Wittenberg
06120 Halle
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20249 Hamburg
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22087 Hamburg
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22763 Hamburg
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Carl-Neuberg-Straße 1
30625 Hannover
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69121 Heidelberg
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74078 Heilbronn
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07740 Jena
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Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histological or cytologically confirmed adenocarcinoma of the pancreas that has not

been previously treated in the metastatic setting.

- Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to

screening.

- Subject has one or more metastatic tumours measurable by computed tomography (CT) scan

(or magnetic resonance imaging (MRI), if the subject is allergic to CT contrast media)

according to RECIST Version 1.1 criteria.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Subject has adequate biological parameters as demonstrated by the following blood

counts:(a) Absolute neutrophil count (ANC) ≥2000/mm3 without the use of hemopoietic

growth factors within the last 7 days prior to randomisation (b) Platelet count

≥100,000/mm3 (c) Haemoglobin (Hgb) ≥9 g/dL obtained ≤14 days prior to randomisation.

- Adequate hepatic function as evidenced by: (a) Serum total bilirubin ≤1.5x ULN

(biliary drainage is allowed for biliary obstruction), and (b) Aspartate

aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x upper limit of normal

(ULN) (≤5x ULN is acceptable if liver metastases are present).

- Adequate renal function as evidenced by creatinine clearance ≥30 mL/min.

- Adequate coagulation studies (obtained ≤14 days prior to randomisation) as

demonstrated by prothrombin time and partial thromboplastin time within normal limits

(≤1.5xULN ).

Exclusion Criteria:

- Prior treatment of pancreatic cancer in the metastatic setting with surgery,

radiotherapy, chemotherapy or investigational therapy

- Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant

setting, except those where at least 12 months have elapsed since completion of the

last dose and no persistent treatment-related toxicities are present.

- Subject has only localised advanced disease.

- Documented serum albumin <3 g/dL

- Known history of central nervous system (CNS) metastases.

- Clinically significant gastrointestinal disorder

- History of any second malignancy in the last 2 years

- Concurrent illnesses that would be a relative contraindication to trial participation

- Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1

- Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma

- Known low or absent dihydropyrimidine dehydrogenase (DPD) activity

Studien-Rationale

Primary outcome:

1. Overall survival (OS) (Time Frame - From study start until 565 OS events have occurred (approximately 15 months after last patient enrollment))



Secondary outcome:

1. Progression free survival (PFS) (Time Frame - From study start until 565 OS events have occurred (approximately 15 months after last patient enrollment))

2. Overall Response Rate (ORR) (Time Frame - From study start until 565 OS events have occurred (approximately 15 months after last patient enrollment))

Studien-Arme

  • Experimental: Irinotecan liposome injection + Oxaliplatin + 5-FU/LV
    Irinotecan liposome injection, oxaliplatin, 5 FU/LV, will be administered on Days 1 and 15 of each 28-day cycle (until progression or unacceptable toxicity).
  • Active Comparator: Nab-paclitaxel + Gemcitabine
    Nab-paclitaxel and gemcitabine will be administered on Days 1, 8 and 15 of each 28-day cycle (until progression or unacceptable toxicity).

Geprüfte Regime

  • Irinotecan Liposomal Injection (Onivyde® / Nal-IRI / ):
    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 (Eloxatin®):
    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.
  • 5Fluorouracil (Adrucil® / flurouracil / 5-FU / ):
    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 (Folinic Acid):
    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 (Abraxane®):
    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 (Gemzar®):
    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.

Quelle: ClinicalTrials.gov


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