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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: Completed Phase 1 study, sponsored by Celgene.
NCT01915498 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 345 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (475% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Toxicity severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. A DLT was defined as: • Non-hematologic toxicities: CTCAE ≥ Grade 3 with the exception of ≥ Grade 3 blood bilirubin increases in participants with a uridine diphosphate- glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) mutation. In participants with a UGT1A1 mutation, blood bilirubin increases of \> 5× upper limit of normal (ULN) were considere
Interventions
- DRUG Enasidenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2013-08-27 |
| Est. Completion | 2023-10-31 |
| Phase | Phase 1 |
What the finished NCT01915498 record still lists
NCT01915498 is an interventional study that assigns participants to a tested intervention. The registered 345 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (475% higher).
The record links to 0 conditions, and to 1 intervention - of which Enasidenib is the first listed.
NCT01915498 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01915498's enrollment target sits among peer trials
345 100th of 2000 higher than 1,899 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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