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

NCT01189903 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2014-01-28

No results posted yet for this study

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)

Conditions

  • Asian Colorectal Cancer Patients

Interventions

DRUG

Regorafenib

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Boon Cher Goh, MBBS, MRCP · National University Hospital, Singapore

Study Design

Purpose
TREATMENT

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-08-31

Countries

  • Singapore

Study Locations

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Entities

Drugs

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 NCT01189903 on ClinicalTrials.gov