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Trial of FOLF(HA)Iri With Cetuximab in mCRC

NCT02216487 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2014-08-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

HA-Irinotecan

HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan for treatment of mCRC.

Sponsors & Collaborators

  • Alchemia Oncology

    collaborator INDUSTRY

  • Merck Serono International SA

    collaborator INDUSTRY

  • Western General Hospital, Australia

    lead OTHER

Principal Investigators

  • Peter Gibbs, MD · Western General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-06-30
Completion
2016-11-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02216487 on ClinicalTrials.gov