Ignite Creation Date:
2024-05-06 @ 1:59 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01949194
Status:
UNKNOWN
Last Update Posted:
2018-08-10
First Post:
2013-09-11
Brief Title:
Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers
Sponsor:
Gerald Batist
Organization:
Jewish General Hospital
Study Overview
Official Title:
A Phase II Exploratory Study to Identify Biomarkers Predictive of Clinical Response to Regorafenib in Patients With Metastatic Colorectal Cancer Who Have Failed First-line Therapy
Status:
UNKNOWN
Status Verified Date:
2018-08
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:
In recent years anti-angiogenic agents have been incorporated into clinical practice for the treatment of metastatic CRC leading to improvements in progression-free survival and overall survival Regorafenib is an oral multi-kinase inhibitor that targets angiogenic and oncogenic kinases Although structurally similar to another multi-kinase inhibitor sorafenib it appears to be pharmacologically more potent and possesses broader antiangiogenic properties
Both sorafenib and regorafenib target BRAF wild-type and BRAF V600E mutant but the inhibition of p38 MAP kinase is a peculiar characteristic of regorafenib A Phase I study of regorafenib as a single agent in patients with heavily pretreated CRC showed promising clinical activity with a disease control rate PR SD of 59 in evaluable patients In the Phase III trial CORRECT which was a randomized double-blind placebo-controlled study comparing either regorafenib plus best supportive care BSC or placebo plus BSC it was shown that regorafenib significantly increased overall survival OS progression-free survival PFS and disease control rate DCR independently of KRAS status A major interest given the data presented in the CORRECT trial is to determine predictive biomarkers to indicate patients likely to benefit or to be resistant to this anti-angiogenic compound
This study aims to determine the efficacy of regorafenib as single-agent treatment for the treatment of second-line metastatic colorectal cancer and to identify predictive biomarkers in the actual metastatic tumors to be treated In the case of metastatic CRC patients liver lesions are frequently the most common site of metastatic deposit and these lesions can be biopsied to assess putative biomarkers Patients will be asked to undergo a biopsy of a metastatic lesion prior to treatment and an optional liver biopsy at the time of relapse Using several high-throughput discovery platforms biomarkers will be identified in the metastatic tumor specimens and in blood samples collected throughout the treatment This will allow us to evaluate putative biomarkers and monitor tumor biomarker dynamics using serial blood collection
The objectives of this trial are to help identify the patient subgroup most likely to be responsive or resistant to regorafenib so that future treatment with regorafenib can be directed to the more responsive but as yet identified patient population
Both sorafenib and regorafenib target BRAF wild-type and BRAF V600E mutant but the inhibition of p38 MAP kinase is a peculiar characteristic of regorafenib A Phase I study of regorafenib as a single agent in patients with heavily pretreated CRC showed promising clinical activity with a disease control rate PR SD of 59 in evaluable patients In the Phase III trial CORRECT which was a randomized double-blind placebo-controlled study comparing either regorafenib plus best supportive care BSC or placebo plus BSC it was shown that regorafenib significantly increased overall survival OS progression-free survival PFS and disease control rate DCR independently of KRAS status A major interest given the data presented in the CORRECT trial is to determine predictive biomarkers to indicate patients likely to benefit or to be resistant to this anti-angiogenic compound
This study aims to determine the efficacy of regorafenib as single-agent treatment for the treatment of second-line metastatic colorectal cancer and to identify predictive biomarkers in the actual metastatic tumors to be treated In the case of metastatic CRC patients liver lesions are frequently the most common site of metastatic deposit and these lesions can be biopsied to assess putative biomarkers Patients will be asked to undergo a biopsy of a metastatic lesion prior to treatment and an optional liver biopsy at the time of relapse Using several high-throughput discovery platforms biomarkers will be identified in the metastatic tumor specimens and in blood samples collected throughout the treatment This will allow us to evaluate putative biomarkers and monitor tumor biomarker dynamics using serial blood collection
The objectives of this trial are to help identify the patient subgroup most likely to be responsive or resistant to regorafenib so that future treatment with regorafenib can be directed to the more responsive but as yet identified patient population
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None