Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
Public ClinicalTrials.gov record NCT02719574. 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 Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.
Study identification
- NCT ID
- NCT02719574
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 336 participants
Conditions and interventions
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
- Apr 30, 2016 (Actual)
- Primary completion
- Dec 28, 2023 (Actual)
- Completion
- Jan 24, 2024 (Actual)
- Last update posted
- Jun 29, 2026
2016 – 2024
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90024 | — |
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Yale University | New Haven | Connecticut | 06510 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Emory Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| New York Medical College | Hawthorne | New York | 10532 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Cornell University Weill Medical College | New York | New York | 10065 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Oregon Health & Science University | Portland | Oregon | 97229 | — |
| Sarah Cannon Research Institute - Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| 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 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02719574, 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 Jun 29, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02719574 live on ClinicalTrials.gov.