Ignite Creation Date:
2024-05-06 @ 7:40 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02579616
Status:
COMPLETED
Last Update Posted:
2020-12-23
First Post:
2015-10-16
Brief Title:
Study of Lenvatinib E7080 in Unresectable Biliary Tract Cancer BTC Who Failed Gemcitabine-based Combination Chemotherapy
Sponsor:
Eisai Co Ltd
Organization:
Eisai Inc
Study Overview
Official Title:
An Open-Label Multicenter Phase 2 Study of E7080 LENVIMA Lenvatinib Mesylate in Subjects With Unresectable Biliary Tract Cancer Who Failed Gemcitabine-based Combination Chemotherapy
Status:
COMPLETED
Status Verified Date:
2020-10
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 is a multicenter single arm open-label study in participants with unresectable BTC and disease progression or failure following one prior gemcitabine-based doublet chemotherapy regimen combination of gemcitabine and cisplatin or gemcitabine and other platinum agentfluoropyrimidine agent This study contains 3 phases a Pre-treatment phase that will last within 21 days a Treatment phase that will consist of study treatment cycles and tumor assessment conducted every 6-8 weeks and a Follow-up phase that will begin immediately after the Off-Treatment Visit and will continue as long as the participant is alive unless the participant withdraws consent or until the End of Study
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