Ignite Creation Date:
2024-07-17 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501625
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-09
Brief Title:
Ivosidenib Plus Durvalumab and GemcitabineCisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Sponsor:
Institut de Recherches Internationales Servier
Organization:
Servier
Study Overview
Official Title:
A Phase 1b2 Safety Lead-in and Dose-Expansion Open Label Multicenter Trial Investigating the Safety Tolerability and Preliminary Activity of Ivosidenib in Combination With Durvalumab and GemcitabineCisplatin as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Status:
NOT_YET_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 objective of this study is to investigate the safety tolerability and preliminary activity of ivosidenib in combination with durvalumab and gemcitabinecisplatin as first-line therapy in participants with locally advanced unresectable or metastatic cholangiocarcinoma with an IDH1 mutation The study will begin with a safety lead-in phase Phase 1b study to determine the recommended combination dose RDC and then will transition to an expansion phase Phase 2 study to assess the clinical activity of ivosidenib in combination with durvalumab and gemcitabinecisplatin at the RCD During the treatment period participants will have study visits on days 1 8 and 15 of Cycle 1 on days 1 and 8 of Cycle 2 to 8 and on day 1 of each additional cycle Cycles 1 through 8 are 21 day cycles and each following cycle is 28 days Approximately 30 days and 90 days after treatment has ended safety follow-up visits will occur and then participants will be followed for survival every 3 months Study visits may include blood tests ECG vital signs and a physical examination
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| 2024-514261-19-00 | CTIS | None | None |