nal-IRI

DRUG6 trials

Conditions

Cholangiocarcinoma AdvancedCholangiocarcinoma MetastaticCholangiocarcinoma Non-resectableCholangiocarcinoma of the GallbladderColorectal CancerEsophageal AdenocarcinomaGastric AdenocarcinomaLocally Advanced Rectal Cancer (LARC)

Phase 1

Evaluation of MM-151 + Nal-IRI + 5-FU + Leucovorin in RAS/RAF Wild-type Metastatic Colorectal Cancer

WithdrawnNCT02785068

Merrimack PharmaceuticalsColorectal Cancer

Start: 2016-07-31End: 2018-10-31Updated: 2017-01-11

Phase 2

Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

CompletedNCT02551991

IpsenPancreatic Cancer

Start: 2015-10-19End: 2021-02-15Updated: 2022-10-10

Nal-IRI and 5-FU Compared to 5-FU in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies

CompletedNCT03043547

AIO-Studien-gGmbHCholangiocarcinoma Advanced, Cholangiocarcinoma Metastatic, Cholangiocarcinoma Non-resectable +1

Start: 2017-10-24End: 2022-03-08Updated: 2022-05-18

A Study to Evaluate a Chemotherapy Treatment Followed by Chemo and Radiotherapy in Patients With Rectal Cancer

CompletedNCT04009876

Fundación de investigación HMLocally Advanced Rectal Cancer (LARC)

Start: 2019-05-01End: 2022-10-21Updated: 2022-12-13

Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma

RecruitingNCT04150640

University of Wisconsin, MadisonEsophageal Adenocarcinoma, Gastric Adenocarcinoma

Start: 2020-07-13End: 2027-12-01Target: 52Updated: 2026-02-24

PANORAMIX : Optimizing 1st-line NALIRIFOX and Exploring Microbiota's Role in 2nd Line Pancreatic Cancer Treatment

Not yet recruitingNCT07028424

GERCOR - Multidisciplinary Oncology Cooperative GroupPDAC - Pancreatic Ductal Adenocarcinoma

Start: 2025-07-31End: 2030-12-31Target: 206Updated: 2025-07-01

2025-03-253 citations

Nanoliposomal irinotecan and fluorouracil plus leucovorin versus fluorouracil plus leucovorin in patients with cholangiocarcinoma and gallbladder carcinoma previously treated with gemcitabine-based therapies (AIO NALIRICC): a multicentre, open-label, randomised, phase 2 trial.

2024-06-1023 citations

NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial.

2023-09-11295 citations

Liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): 12- and 18-month survival rates from the phase 3 NAPOLI 3 trial.

Journal of Clinical Oncology2023-06-013 citations

NAPOLI-3: A randomized, open-label phase 3 study of liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

Journal of Clinical Oncology2023-01-2466 citations

Phase II, multicenter, open-label, non-randomized study of neoadjuvant chemotherapy NALIRINOX (5-FU/LV + oxaliplatin + nal-IRI) followed by chemoradiotherapy in patients with rectal cancer in a watch-and-wait program.

Journal of Clinical Oncology2022-06-01

Population pharmacokinetics of liposomal irinotecan in patients with cancer and exposure–safety analyses in patients with metastatic pancreatic cancer

CPT Pharmacometrics & Systems Pharmacology2021-11-0911 citations

Assessing real-world survival outcomes of patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with first-line FOLFIRINOX compared to patients from a phase 1/2 trial treated with NALIRIFOX.

Journal of Clinical Oncology2021-05-20

A phase II study of liposomal irinotecan with 5-fluorouracil, leucovorin and oxaliplatin in patients with resectable pancreatic cancer: the nITRO trial

Therapeutic Advances in Medical Oncology2020-01-0113 citations

Abstract B14: CA 19-9 levels in patients with metastatic pancreatic adenocarcinoma receiving first-line therapy with liposomal irinotecan plus 5-fluorouracil/leucovorin and oxaliplatin (NAPOX)

Cancer Research2019-12-131 citations

Improved Efficacy and Reduced Toxicity Using a Custom-Designed Irinotecan-Delivering Silicasome for Orthotopic Colon Cancer

ACS Nano2018-12-11123 citations

A phase 1/2, open-label dose-escalation study of liposomal irinotecan (nal-IRI) plus 5- fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX) in patients with previously untreated metastatic pancreatic cancer (mPAC).

Journal of Clinical Oncology2018-05-201 citations

Preclinical antitumor activity of nanoliposomal irinotecan (Nal-IRI, MM-398) and utilization as a foundation of front-line pancreatic cancer regimens.

Journal of Clinical Oncology2017-02-01

Abstract 4830: Preclinical anti-tumor activity of nanoliposomal irinotecan (Nal-IRI, MM-398) + 5-FU + oxaliplatin in pancreatic cancer

Cancer Research2016-07-151 citations

A randomized, open-label phase II study of nanoliposomal irinotecan (nal-IRI)-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated metastatic pancreatic adenocarcinoma (mPAC).

Journal of Clinical Oncology2016-02-013 citations

nal-IRI

Sponsors

Conditions

Phase 1

Phase 2

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