Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607302
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - a Prospective Multicenter Observational Study in Germany
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDHIRA
Brief Summary:
Cholangiocarcinoma is a rare and aggressive tumor of the bile duct associated with a poor prognosis and very limited treatment options The IDH1 inhibitor ivosidenib provides a new targeted treatment option for this disease Ivosidenib was approved by European Medicines Agency EMA in May 2023 as monotherapy in adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy
The prospective multicenter observational study IDHIRA will collect first real-world data on ivosidenib treatment in a broad patient population in Germany Ivosidenib will be administered according to the current SmPC Thus IDHIRA will generate real-world evidence on effectiveness quality of life QoL and safety of ivosidenib
The prospective multicenter observational study IDHIRA will collect first real-world data on ivosidenib treatment in a broad patient population in Germany Ivosidenib will be administered according to the current SmPC Thus IDHIRA will generate real-world evidence on effectiveness quality of life QoL and safety of ivosidenib
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