Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation
Public ClinicalTrials.gov record NCT01915498. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-221 in Subjects With Advanced Hematologic Malignancies With an IDH2 Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01915498
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 345 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 27, 2013 (Actual)
- Primary completion
- Jul 25, 2019 (Actual)
- Completion
- Oct 31, 2023 (Actual)
- Last update posted
- Oct 22, 2024
2013 – 2023
United States locations
- U.S. sites
- 19
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City Of Hope | Duarte | California | 91010-301 | — |
| Stanford Cancer Center | Stanford | California | 94305 | — |
| University Of Colorado Cancer Center | Aurora | Colorado | 80045 | — |
| University of Miami Sylvester Cancer Center | Miami | Florida | 33136 | — |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Northwestern University | Chicago | Illinois | 60611-3008 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02117 | — |
| Dana-Farber/Mass General Brigham Cancer Care, Inc | Boston | Massachusetts | 02215 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Cornell University Weill Medical College | New York | New York | 10065 | — |
| Memorial Sloan-Kettering Cancer Center - NYC | New York | New York | 10065 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Ohio State University | Gahanna | Ohio | 43230 | — |
| Oregon Health and Science University OHSU | Portland | Oregon | 97239 | — |
| Sarah Cannon Research Institute Drug Development Unit | Nashville | Tennessee | 37203 | — |
| Ut Southwestern Medical Center At Dallas | Dallas | Texas | 75390-85520 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01915498, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 22, 2024 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01915498 live on ClinicalTrials.gov.