Ignite Creation Date:
2024-05-06 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05174650
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-23
First Post:
2021-11-09
Brief Title:
Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 FusionsRearrangements
Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Organization:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study Overview
Official Title:
A Phase II Single-arm Open-label Study of Atezolizumab and Derazantinib for Patients With Advanced Intrahepatic Cholangiocarcinoma With FGFR2
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
The study trial is a open-label single-arm multicenter phase II trial investigating the combined treatment of atezolizumab and derazantinib in patients with advanced intrahepatic cholangiocarcinoma with FGFR2 fusionsrearrangements
Detailed Description:
The aim of this phase II study is to explore the safety and anti-tumor efficacy of the combination of atezolizumab and derazantinib in patients with advanced intrahepatic cholangiocarcinoma with ORR as the primary endpoint
The primary endpoint is the Objective Response Rate ORR assessed every 8 weeks 7 days
Objective response rate ORR according to investigator-based RECIST 11 assessment defined as the proportion of allocated subjects with best response of complete or partial response within 9 months after the date of first administration of study treatment
The secondary endpoints are safety and efficacy and will be evaluated by
Incidence treatment relationship seriousness and severity of all AEs SAEs AESIs according to CTCAE V50
ORREOT
Objective response rate ORR according to investigator-based RECIST 11 assessment defined as the proportion of allocated subjects with best response of complete or partial response within study treatment
PFSR6 8 and 10 months The proportion of patients known to be alive and without confirmed objective disease progression at 6 8 and 10 months after first administration of study treatment respectively
PFS Time from first administration of study treatment until the date of first objective disease progression or death
OS Time from first administration of study treatment until death of a patient due to any cause
The primary endpoint is the Objective Response Rate ORR assessed every 8 weeks 7 days
Objective response rate ORR according to investigator-based RECIST 11 assessment defined as the proportion of allocated subjects with best response of complete or partial response within 9 months after the date of first administration of study treatment
The secondary endpoints are safety and efficacy and will be evaluated by
Incidence treatment relationship seriousness and severity of all AEs SAEs AESIs according to CTCAE V50
ORREOT
Objective response rate ORR according to investigator-based RECIST 11 assessment defined as the proportion of allocated subjects with best response of complete or partial response within study treatment
PFSR6 8 and 10 months The proportion of patients known to be alive and without confirmed objective disease progression at 6 8 and 10 months after first administration of study treatment respectively
PFS Time from first administration of study treatment until the date of first objective disease progression or death
OS Time from first administration of study treatment until death of a patient due to any cause
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None