Clavis Pharma's CP-4126 Enters New Phase II Clinical Trial in Pancreatic Cancer Patients Refractory to 1st line Gemcitabine Therapy

07-Feb-2011 - Norway

Clavis Pharma announced that its partner, Clovis Oncology, Inc., has recruited the first patient into a Phase II clinical study (CO-101-003 study) with CP-4126 (also known as CO-101). This trial will investigate the use of CP-4126 as a 2nd line treatment for advanced, metastatic pancreatic cancer in patients refractory to 1st line gemcitabine treatment, where the mechanism of resistance is likely to be due to impaired drug entry into tumour cells.

CP-4126 is a novel, patented, lipid-conjugated derivative of the anti-cancer drug gemcitabine, developed using Clavis' lipid vector technology (LVT). Due to its different molecular design, CP-4126 is absorbed by cancer cells independent of hENT1 levels, which may lead to an improvement in efficacy in the poorly-served group of patients with no or low hENT1 expression.

The CO-101-003 study is a 35-patient, single arm, Simon 2- stage, Phase II multicentre study that will be conducted at US sites. Patients with advanced, metastatic pancreatic cancer will be eligible for inclusion if they were refractory to 1st line gemcitabine treatment (gemcitabine-refractory) and their tumours show no expression of hENT1. The primary objective of this study is to determine disease control rate (DCR or best response of complete response [CR], partial response [PR], or stable disease [SD]). CP-4126 treatment will continue will continue until tumour progression or toxicity occurs.

CP-4126 is also being evaluated as a 1st line therapy in a head-to-head comparison with gemcitabine in an ongoing Phase II, pivotal trial (study CO-101-001).

https://www.bionity.com/en/news/130681/clavis-pharma-s-cp-4126-enters-new-phase-ii-clinical-trial-in-pancreatic-cancer-patients-refractory-to-1st-line-gemcitabine-therapy.html