Ignite Creation Date:
2024-05-06 @ 6:10 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05565794
Status:
RECRUITING
Last Update Posted:
2023-08-28
First Post:
2022-09-28
Brief Title:
Pemigatinib After Curative Local Therapy in Advanced iCCA With FGFR2 FusionRearrangements
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 Study of Pemigatinib After Curative Local Therapy in Locally Advanced Intrahepatic Cholangiocarcinoma iCCA Harboring FGFR2 FusionsRearrangements
Status:
RECRUITING
Status Verified Date:
2023-08
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 aim of this phase II study is to determine whether pemigatinib is clinically efficious after curative local therapy such as surgery SBRT or ablation in iCCA patients harboring FGFR2 fusionrearrangement and to assess the safety profile to support the continuation of the concept in a large randomized trial for further development
Detailed Description:
This is a prospective exploratory single-arm non-randomized open-label phase II study to investigate whether pemigatinib is clinically efficacious after curative local treatment including surgery SBRT or ablation in iCCA patients with FGFR2 fusionrearrangements
Patients will receive pemigatinib 135 mg oral once daily 21-day cycle two weeks on one week off until disease recurrence unacceptable toxicity withdrawal of consent or investigator decision but no longer than 12 months max 18 cycles
The primary objective is to assess the efficacy of pemigatinib administered after curative local therapy in treatment-naïve patients with resectable intrahepatic biliary tract cancer recurrence free survival rate at 12 months RFS12
Secondary objectives are to assess the efficacy by overall survival OS and recurrence free survival RFS to assess safety of the treatment AEs impact on liver function use of subsequent therapies to assess quality of life QoL
In addition tissue samples will be analyzed for biomarkers predictive for RFS and OS
20 patients are to be enrolled in this trial
Patients will receive pemigatinib 135 mg oral once daily 21-day cycle two weeks on one week off until disease recurrence unacceptable toxicity withdrawal of consent or investigator decision but no longer than 12 months max 18 cycles
The primary objective is to assess the efficacy of pemigatinib administered after curative local therapy in treatment-naïve patients with resectable intrahepatic biliary tract cancer recurrence free survival rate at 12 months RFS12
Secondary objectives are to assess the efficacy by overall survival OS and recurrence free survival RFS to assess safety of the treatment AEs impact on liver function use of subsequent therapies to assess quality of life QoL
In addition tissue samples will be analyzed for biomarkers predictive for RFS and OS
20 patients are to be enrolled in this trial
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IKF-t055 | OTHER | IKF Trial ID | None |
| 2021-006232-50 | EUDRACT_NUMBER | None | None |