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)
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|ClinicalTrials.gov Identifier: NCT04083235|
Recruitment Status : Active, not recruiting
First Posted : September 10, 2019
Last Update Posted : March 13, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Metastatic Adenocarcinoma of the Pancreas||Drug: Irinotecan Liposomal Injection Drug: Oxaliplatin Drug: 5Fluorouracil Drug: Leucovorin Drug: Nab-paclitaxel Drug: Gemcitabine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||770 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||February 19, 2020|
|Actual Primary Completion Date :||July 23, 2022|
|Estimated Study Completion Date :||December 31, 2023|
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).
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).
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®
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.
Other Name: Folinic Acid
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).
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®
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®
- Overall survival (OS) [ Time Frame: From study start until 543 OS events have occurred (approximately 15 months after last patient enrollment) ]
- Progression free survival (PFS) [ Time Frame: From study start until 543 OS events have occurred (approximately 15 months after last patient enrollment) ]
- Overall Response Rate (ORR) [ Time Frame: From study start until 543 OS events have occurred (approximately 15 months after last patient enrollment) ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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 lesions 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 ).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083235
|Study Director:||Ipsen Medical Director||Ipsen|
|Other Study ID Numbers:||
2018-003585-14 ( EudraCT Number )
|First Posted:||September 10, 2019 Key Record Dates|
|Last Update Posted:||March 13, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|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.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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