Ignite Creation Date:
2024-05-06 @ 8:36 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02773459
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2016-05-13
Brief Title:
MEK162 in Combination With Capecitabine in Advanced Biliary Tract Cancer
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Phase Ib Study of MEK162 in Combination With Capecitabine in Gemcitabine-pretreated Advanced Biliary Tract Cancer
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
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:
This study is to test the efficacy of MEK162 plus capecitabine in gemcitabine-pretreated advanced biliary tract cancer and to explore the predictive biomarkers for future large-scale clinical trials using this combination
Detailed Description:
Biliary tract cancer is one of rare cancers which is relatively more frequent in east Asia The frequency of KRAS mutation andor BRAF mutation is reported at 40 to 60 The prognosis is still very poor with only limited treatment options The most commonly used 1st-line chemotherapy is gemcitabinecisplatin combination In gemcitabine-pretreated advanced biliary tract cancer fluoropyrimidine-based chemotherapy is used However the overall survival with these cytotoxic chemotherapies is still only about 8-10 months calling for urgent development of efficient treatment options
Recently mitogen-activated extracellular signal regulated kinase kinase MEK inhibition was shown to have antitumor effects in KRAS mutated biliary tract cancers in preclinical model In phase II study of MEK inhibitor selumetinib in metastatic biliary tract cancers selumetinib displayed interesting activity and acceptable tolerability
MEK162 is an oral highly selective MEK inhibitor It was shown to promote apoptosis and in vivo antitumor activity against human biliary tract cancer cell lines So far there has been no study to test the MEK inhibitor mainly in gemcitabine-pretreated advanced biliary tract cancer especially in combination of capecitabine chemotherapy
The aim of this study is to test the efficacy of MEK162 plus capecitabine in gemcitabine-pretreated advanced biliary tract cancer and to explore the predictive biomarkers for future large-scale clinical trials using this combination
Recently mitogen-activated extracellular signal regulated kinase kinase MEK inhibition was shown to have antitumor effects in KRAS mutated biliary tract cancers in preclinical model In phase II study of MEK inhibitor selumetinib in metastatic biliary tract cancers selumetinib displayed interesting activity and acceptable tolerability
MEK162 is an oral highly selective MEK inhibitor It was shown to promote apoptosis and in vivo antitumor activity against human biliary tract cancer cell lines So far there has been no study to test the MEK inhibitor mainly in gemcitabine-pretreated advanced biliary tract cancer especially in combination of capecitabine chemotherapy
The aim of this study is to test the efficacy of MEK162 plus capecitabine in gemcitabine-pretreated advanced biliary tract cancer and to explore the predictive biomarkers for future large-scale clinical trials using this combination
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