Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT01189903
Status:
UNKNOWN
Last Update Posted:
2014-01-28
First Post:
2010-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients
Sponsor:
National University Hospital, Singapore
Organization:
Study Overview
Official Title:
Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2014-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
* 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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: