Metastatic Colorectal Cancer Clinical Trial
Official title:
Phase II Single Arm Trial of FOLF(HA)Iri Plus Cetuximab in Irinotecan-naïve Second Line Patients With KRAS Wild Type Metastatic Colorectal Cancer
As an approach to improve efficacy and provide clinical benefit to cancer patients
undergoing chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel
means for delivering anti-cancer agents to tumours. The drug delivery platform is based on
the use of hyaluronic acid (HA), a novel excipient, in which, formulation with HA results in
optimisation of cytotoxic drug uptake and retention within solid tumours. In the specific
example of HA-Irinotecan, this new formulation of irinotecan has demonstrated enhanced
efficacy in both nonclinical and early clinical studies.
The current study is an investigation into the use of HA-Irinotecan in a Phase II single arm
trial of FOLF(HA)iri plus cetuximab in irinotecan-naïve second line patients with KRAS wild
type metastatic colorectal cancer. The study objectives are to confirm the safety and
efficacy of FOLF(HA)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic
colorectal cancer patients.
It is expected that the study recruit approximately 40-50 patients in 1 year with subsequent
treatment and follow up; thus the trial will run for approximately 2-3 years.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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