Ignite Creation Date:
2024-05-06 @ 2:55 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02162914
Status:
UNKNOWN
Last Update Posted:
2020-07-31
First Post:
2014-05-26
Brief Title:
Regorafenib Versus Placebo to Treat Cholangiocarcinoma
Sponsor:
Erasme University Hospital
Organization:
Erasme University Hospital
Study Overview
Official Title:
REGORAFENIB AFTER FAILURE OF GEMCITABINE AND PLATINUM-BASED CHEMOTHERAPY FOR LOCALLY ADVANCED NON RESECTABLE AND METASTATIC INTRA-HEPATIC OR HILAR CHOLANGIOCARCINOMA A Randomized Double-blinded Phase II Trial
Status:
UNKNOWN
Status Verified Date:
2020-07
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:
REACHIN
Brief Summary:
The study is a multicenter randomized 11 placebo-controlled double-blinded phase II trial aiming to demonstrate an improvement of median PFS when treating locally advanced unresectable or metastatic patients suffering from an intra-hepatic or hilum mass-forming cholangiocarcinoma with Regorafenib as compared to placebo and after progression after GEM-CDDP or GEM-OX or gemcitabine alone followed or preceded by platinum CDDP or oxaliplatin-based chemotherapy
The principal objective is to investigate Regorafenib efficacy by prospectively evaluating the PFS after the administration of Regorafenib combined with BSC as compared to placebo with BSC Hypothesis is a 50 improvement in median PFS from 6 weeks to 12 weeks in Regorafenib group
The principal objective is to investigate Regorafenib efficacy by prospectively evaluating the PFS after the administration of Regorafenib combined with BSC as compared to placebo with BSC Hypothesis is a 50 improvement in median PFS from 6 weeks to 12 weeks in Regorafenib group
Detailed Description:
The principal objective is to investigate Regorafenib efficacy by prospectively evaluating the PFS after the administration of Regorafenib combined with BSC as compared to placebo with BSC Hypothesis is a 50 improvement in median PFS from 6 weeks to 12 weeks in Regorafenib group
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