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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|ClinicalTrials.gov Identifier: NCT01189903|
Recruitment Status : Unknown
Verified January 2014 by National University Hospital, Singapore.
Recruitment status was: Active, not recruiting
First Posted : August 27, 2010
Last Update Posted : January 28, 2014
- 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)
- 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)
|Condition or disease||Intervention/treatment||Phase|
|Asian Colorectal Cancer Patients||Drug: Regorafenib||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||August 2013|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189903
|National University Hospital|
|Singapore, Singapore, 119074|
|Principal Investigator:||Boon Cher Goh, MBBS, MRCP||National University Hospital, Singapore|