Acute Myeloid Leukemia Clinical Trial
Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
Summary
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.
Eligibility Criteria
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
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There are 46 Locations for this study
Los Angeles California, 90024, United States
Sacramento California, 95817, United States
New Haven Connecticut, 06510, United States
Miami Florida, 33136, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Baltimore Maryland, 21201, United States
Detroit Michigan, 48201, United States
Buffalo New York, 14263, United States
Hawthorne New York, 10532, United States
New York New York, 10032, United States
New York New York, 10065, United States
Durham North Carolina, 27705, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97229, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Adelaide South Australia, 5000, Australia
Melbourne Victoria, 3004, Australia
Parkville Victoria, 3000, Australia
Nedlands Western Australia, 6009, Australia
Box Hill , 3128, Australia
Toronto Ontario, M5G 2, Canada
Bobigny , 93000, France
Marseille , 13005, France
Nantes , 44093, France
Paris , 75010, France
Paris , 75012, France
Pessac , 33604, France
Pierre-Bénite , 69495, France
Rennes , 35033, France
Toulouse , 31059, France
Vandœuvre-lès-Nancy , 54511, France
Villejuif , 94805, France
Braunschweig , , Germany
Gießen , , Germany
Halle (Saale) , , Germany
Münster , , Germany
Orbassano Turin, , Italy
Ascoli Piceno , , Italy
Bologna , , Italy
Meldola , , Italy
Parma , , Italy
Ravenna , , Italy
Rimini , , Italy
Gumi , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Barcelona , 08035, Spain
Barcelona , 8036, Spain
Barcelona , 8908, Spain
Madrid , 28041, Spain
Salamanca , 37007, Spain
Valencia , 46026, Spain
London , NW1 2, United Kingdom
London , , United Kingdom
Oxford , , United Kingdom
Southampton , , United Kingdom
Sutton , SM2 5, United Kingdom
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