WHO ICTRP trial
A Phase 3 study to test the AG-120 in combination with Azacitidine in comparison…
CTIS2024-514309-73-00 · EU Clinical Trials Information System · Not Recruiting
Key facts
| Trial ID | CTIS2024-514309-73-00 |
|---|---|
| Public title | A Phase 3 study to test the AG-120 in combination with Azacitidine in comparison with the use of Azacitidine alone in patients = 18 Years of Age with previously untreated Acute Myeloid Leukemia with an IDH1 Mutation |
| Scientific title | A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination with Azacitidine in Subjects =18 Years of Age with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation - AG120-C-009 |
| Primary sponsor | Institut De Recherches Internationales Servier IRIS |
| Registry | EU Clinical Trials Information System |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): No Therapeutic confirmatory - (Phase III): Yes Therapeutic use - (Phase IV): No |
| Countries | Canada;Taiwan;Israel;Russian Federation;Japan;Korea, Republic of;United States;China;United Kingdom;Mexico;Brazil;Australia;Poland;Spain;Italy;France;Germany |
| Conditions | Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation MedDRA version: 21.0Level: LLTClassification code: 10028557Term: Myeloid leukemia acute Class: 10029104;Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15] |
| Interventions | Product Name: AG-120/S95031 250mg film-coated tablet, Product Code:PRD10101805, Pharmaceutical Form: FILM-COATED TABLET, Other descriptive name: , Strength: , Product Name: Vidaza 25 mg/ml powder for suspension for injection, Product… |
| Registration date | Oct 14, 2024 |
| Target size | 141 |
| Secondary IDs | NCT03173248;2016-004907-30 |
| Registry page | euclinicaltrials.eu |
At a glance
- No Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: