Gemcitabine + Oxaliplatin +Nab-paclitaxel in Subjects With Advanced Biliary Tract Cancer

Summary

The objective of the study is to determine a new combination of drug that improves the outcome in patients with advanced (unresectable or metastatic) BTC. The primary objective of the phase I part of the study is to determine the maximum tolerated dose (MTD) of the combination gemcitabine plus oxaliplatin plus nab-paclitaxel, established in the first cycle of therapy, in order to determine the recommended phase II dose (RP2D). The primary objective of the phase II is to determine activity of GEMOX plus nab-paclitaxel. The secondary objectives of the study consist in to better define the safety profile and the outcome of the study treated population.

Timeline

Start

2017-07-21

Primary completion

2020-09-01

Completion

2021-05-01

Outcome

Missed primary endpoint

paper However, the study did not meet its primary endpoint. PMID 38954899 ↗

Publications

• Pressiani T, Balsano R, Giordano L, Milella M, Bergamo F, Bozzarelli S, Noventa S, Ferrrari D, Scartozzi M, Parra HS, Auriemma A, Solda C, Zaniboni A, Zecchetto C, Rizzato MD, Rimassa L, Santoro A. Multicenter phase I/II trial of gemcitabine, oxaliplatin and nab-paclitaxel as first-line treatment for patients with advanced biliary tract cancer. Eur J Cancer. 2024 Aug;207:114196. doi: 10.1016/j.ejca.2024.114196. Epub 2024 Jun 29.

Drugs

Indications