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NCT01915498 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 345
- Enrollment target
NCT01915498 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 345 participants.
The verdict
NCT01915498, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 345 participants
- Enrollment target
Study Summary
The primary objectives of Phase 1 Dose Escalation/Part 1 Expansion are: * To assess the safety and tolerability of treatment with enasidenib administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle in participants with advanced hematologic malignancies. * To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of enasidenib in participants with advanced hematologic malignancies. The primary objective of Phase 2 is: • To assess the efficacy of enasidenib as treatment for participants with relapsed or refractory (R/R) acute myelogenous leukemia (AML) with an IDH2 mutation.
Interventions
- DRUG Enasidenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2013-08-27 |
| Est. Completion | 2023-10-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01915498
The ClinicalTrials.gov registry entry for NCT01915498 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 345 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Enasidenib is the first listed.
NCT01915498 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01915498 about?
NCT01915498 is a clinical study titled "Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation". The primary objectives of Phase 1 Dose Escalation/Part 1 Expansion are: * To assess the safety and tolerability of treatment with enasidenib administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle in participants with advanced hematologic malignancies. * To determ...
What is the current status of trial NCT01915498?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 345 participants. The study started on 2013-08-27. Estimated completion is 2023-10-31.
What interventions are being tested in trial NCT01915498?
The interventions under investigation include: Enasidenib (DRUG).
Who is sponsoring clinical trial NCT01915498?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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