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Trial 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.

Acronym:

NAPOLI 3

ACTRN/NCT /ethics:

NCT04083235

Scientific 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

Sponsor / Cooperative group:

Ipsen

Trial & Patient Characteristics

Cancer TypePancreas
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexBoth
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced; Metastatic or Widespread
Anticipated Start Date2020-02-19
Anticipated End Date-

Participating Hospitals

HospitalThe Queen Elizabeth Hospital
Clinical Trial CoordinatorPamela Cooper
Emailpamela.cooper@sa.gov.au
Phone08 8222 6140
Principal InvestigatorDr Vy Broadbridge
Recruitment StatusRecruiting