NAPOLI 3
08 Dec 2020
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 Type | Pancreas |
|---|---|
| Trial Type | Treatment |
| Phase | Phase III |
| Age Range | 18 years and older |
| Sex | Both |
| Tumour Stream | - |
| Cancer Stage | Locally Recurrent or Locally Advanced; Metastatic or Widespread |
| Anticipated Start Date | 2020-02-19 |
| Anticipated End Date | - |
Participating Hospitals
| Hospital | The Queen Elizabeth Hospital |
|---|---|
| Clinical Trial Coordinator | Pamela Cooper |
| pamela.cooper@sa.gov.au | |
| Phone | 08 8222 6140 |
| Principal Investigator | Dr Vy Broadbridge |
| Recruitment Status | Recruiting |