Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05876754
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-05-17
Brief Title:
An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
Sponsor:
Servier Affaires Médicales
Organization:
Servier
Study Overview
Official Title:
An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-09
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:
ProvIDHe
Brief Summary:
A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated locally advanced or metastatic cholangiocarcinoma CCA All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles continuing as long as clinical benefit and consent for participation is maintained There will be a minimum of 6 study visits from screening until the final follow-up if one cycle of treatment is completed and consent is maintained through 18 months of follow-up Each additional cycle completed will add one study visit on the first day of each cycle
Detailed Description:
Ivosidenib is approved in the United States and in EU for the treatment of advanced or metastatic CCA this study is being conducted to conslidate the data related to the safety efficacy and impact on quality of life for patients This is an open-label single-arm study of ivosidenib which means that all patients meeting eligibility criteria will receive two 250 mg ivosidenib tablets totaling 500mg of drug to be taken orally once daily for 28 consecutive days also referred to as one cycle Additional cycles can continue as long as clinical benefit is confirmed by an investigator and consent is maintained There will be a screening visit study visit on day 1 of each cycle withdrawal visit within 42 days of stopping treatment and a follow-up visit every 6 months for up to 18 months after stopping treatment This results in a minimum of 6 study visits for the completion of one 28-day cycle of ivosidenib One additional study visit will be added on day one of each additional cycle of treatment Study visits will include an electrocardiogram ECG physical exam tumor assessment according to local practive at a given site and blood and urine analyses If at any point ivosidenib is made available as a medical prescription at the patients site patients will be withdrawn from the study treatment and patients will be followed to collect data on overall survival
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-501463-40 | EUDRACT_NUMBER | None | None |