Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04083235
Previous Study | Return to List | Next Study

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 (NAPOLI 3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083235
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date  ICMJE September 6, 2019
First Posted Date  ICMJE September 10, 2019
Last Update Posted Date September 28, 2020
Actual Study Start Date  ICMJE February 19, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2020)
Overall survival (OS) [ Time Frame: From study start until 565 OS events have occurred (approximately 15 months after last patient enrollment) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2019)
Overall survival (OS) [ Time Frame: From study start until 564 OS events have occurred (approximately 15 months after last patient enrollment) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2020)
  • Progression free survival (PFS) [ Time Frame: From study start until 565 OS events have occurred (approximately 15 months after last patient enrollment) ]
  • Overall Response Rate (ORR) [ Time Frame: From study start until 565 OS events have occurred (approximately 15 months after last patient enrollment) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2019)
  • Progression free survival (PFS) [ Time Frame: From study start until 564 OS events have occurred (approximately 15 months after last patient enrollment) ]
  • Overall Response Rate (ORR) [ Time Frame: From study start until 564 OS events have occurred (approximately 15 months after last patient enrollment) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Adenocarcinoma of the Pancreas
Intervention  ICMJE
  • Drug: Irinotecan Liposomal Injection
    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).
    Other Names:
    • Onivyde®
    • Nal-IRI
  • Drug: Oxaliplatin
    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.
    Other Name: Eloxatin®
  • Drug: 5Fluorouracil
    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.
    Other Names:
    • Adrucil®
    • flurouracil
    • 5-FU
  • Drug: Leucovorin
    Leucovorin Calcium for Injection is supplied in vials ranging from 50-500 mg and available as an injectable solution or lyophilized powder for reconstitution.
    Other Name: Folinic Acid
  • Drug: Nab-paclitaxel
    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.
    Other Name: Abraxane®
  • Drug: Gemcitabine
    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.
    Other Name: Gemzar®
Study Arms  ICMJE
  • 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).
    Interventions:
    • Drug: Irinotecan Liposomal Injection
    • Drug: Oxaliplatin
    • Drug: 5Fluorouracil
    • Drug: Leucovorin
  • 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).
    Interventions:
    • Drug: Nab-paclitaxel
    • Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2019)
750
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Brazil,   Canada,   Czechia,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Portugal,   Russian Federation,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04083235
Other Study ID Numbers  ICMJE D-US-60010-001
2018-003585-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.
Time Frame: Data are available beginning 6 months and ending 5 years after the publication of the findings in a journal; after this time, only raw data may be available.
Access Criteria: Proposals should be submitted to DataSharing@ipsen.com and will be assessed by a scientific review board.
Responsible Party Ipsen
Study Sponsor  ICMJE Ipsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP