Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465953
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-14
Brief Title:
Ivosidenib IVO Monotherapy and Azacitidine AZA Monotherapy in Patients With Hypomethylating Agent HMA Naive Myelodysplastic Syndromes MDS With an IDH1 Mutation
Sponsor:
Institut de Recherches Internationales Servier
Organization:
Servier
Study Overview
Official Title:
A Phase 3 Multicenter Open Label Randomized Non-comparative Two-arm Study of Ivosidenib IVO Monotherapy and Azacitidine AZA Monotherapy in Adult Patients With Hypomethylating Agent HMA Naive Myelodysplastic Syndromes MDS With an Isocitrate Dehydrogenase-1 IDH1 Mutation PyramIDH Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
PyramIDH
Brief Summary:
This study will enroll participants with myelodysplastic syndromes MDS with an Isocitrate dehydrogenase protein 1 IDH1 mutation who have not received treatment with a hypomethylating agent previously Participants will be randomized to receive either ivosidenib IVO alone or azacitidine AZA alone IVO will be administered daily throughout the 28-day treatment cycle and AZA will be administered for the first 7 days of each 28-day cycle Study visits will be conducted every week during Cycle 1 Days 1 8 15 and 22 and Day 1 of each cycle thereafter After the last dose of treatment participants will attend an safety follow-up visit and participants will be followed to assess overall survival Study visits may include a bone marrow aspirate physical exam echocardiogram ECHO electrocardiogram ECG blood and urine analysis and questionnaires
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 |
|---|---|---|---|
| 2023-510155-37 | EUDRACT_NUMBER | None | None |