EICHORCondition: Acute Myeloid Leukemia · Acute Myelogenous Leukemia · Myelodysplastic Syndrome · Sponsor: Forma Therapeutics, Inc.
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * Pathologically proven acute myeloid leukemia (AML) (except acute promyelocytic leukemia \[APL\] with the t(15;17) translocation) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy. * Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site * Good performance status * Good kidney and liver function Exclusion Criteria: * Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy * Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| UCLA Medical Center | Los Angeles, California, United States | — |
| UC Davis Comprehensive Cancer Center | Sacramento, California, United States | — |
| Yale University | New Haven, Connecticut, United States | — |
| University of Miami | Miami, Florida, United States | — |
| Emory Winship Cancer Institute | Atlanta, Georgia, United States | — |
| Northwestern University Feinberg School of Medicine | Chicago, Illinois, United States | — |
| University of Maryland Greenebaum Cancer Center | Baltimore, Maryland, United States | — |
| Karmanos Cancer Institute | Detroit, Michigan, United States | — |
| Roswell Park Cancer Institute | Buffalo, New York, United States | — |
| New York Medical College | Hawthorne, New York, United States | — |
| Columbia University Medical Center | New York, New York, United States | — |
| Cornell University Weill Medical College | New York, New York, United States | — |
+ 48 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT02719574