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Spots Global Cancer Trial Database for Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients

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Trial Identification

Brief Title: Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients

Official Title: Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients

Study ID: NCT01189903

Interventions

Regorafenib

Study Description

Brief Summary: 1. Primary Endpoints * Biomarker data suggestive of regorafenib-mediated inhibition of the RAS-RAF- MEK-ERK signal transduction pathway,of various tyrosine kinase receptors and/or of angiogenesis. * Evaluation of potential relationships between biomarker data and clinical activity. * Evaluation of a novel biomarker technology (Prometheus COPIA platform) 2. Secondary Endpoints * Biomarker data suggestive of regorafenib-mediated effects on circulating rare cells. * Comparison of tumor genetic profiles obtained using DNA isolated from plasma, tumor biopsies and circulating tumor cells. * Patient safety data * Pharmacokinetics of regorafenib * Changes in tumor metabolic activity as measured by PET CT scan (optional)

Detailed Description:

Keywords

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

National University Hospital, Singapore, , Singapore

Contact Details

Name: Boon Cher Goh, MBBS, MRCP

Affiliation: National University Hospital, Singapore

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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