A Study of ASP2215 in Combination with Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia, Trial ID 2215-CL-0103

Study summary

The purpose of this study is to describe the dose limiting toxicities (DLT) and define the maximum tolerated dose (MTD) of ASP2215 when combined with cytarabine/idarubicin or daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of ASP2215 will also be evaluated. This study will also characterize the pharmacokinetics (PK) of ASP2215 when given in combination with cytarabine/idarubicin or cytarabine/daunorubicin remission induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute myeloid leukemia as well as evaluate the effect of ASP2215 on the PK of cytarabine.

Additional Study Details

Phase

Phase 1

Product

gilteritinib

Product

Gilteritinib

Idarubicin

Cytarabine

Daunorubicin

Type

Interventional

Masking

None (Open Label)

Enrollment number

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Locations

Completed

Site US10004

Chicago, IL, United States, 60611

Withdrawn

Site US10008

Columbus, OH, United States, 43201

Completed

Site US10006

Philadelphia, PA, United States, 19104

Completed

Site US10019

Oklahoma City, OK, United States, 73104

Completed

Site US10013

New Haven, CT, United States, 06520

Completed

Site US10014

Cleveland, OH, United States, 44106

Completed

Site US10001

Baltimore, MD, United States, 21231

Completed

Site US10002

New York, NY, United States, 10032

Completed

Site US10009

Westwood, KS, United States, 66205

Completed

Site US10003

Los Angeles, CA, United States, 90095

Completed

Site US10010

San Antonio, TX, United States, 78229

Trial info

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Age

18+ years

Condition

Leukemia - AML

Sex

Female & Male

Trial Dates

Jan 2015 - Jul 2021

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Additional Study Details

Inclusion Criteria

Subject has a diagnosis of previously-untreated de novo acute myeloid leukemia (AML) according to WHO classification (2008) documented within 28 days prior to enrollment.
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Subject must meet the following criteria as indicated on the clinical laboratory tests.
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x institutional upper limit normal (ULN)
- Total serum bilirubin ≤ 1.5 x institutional ULN
- Serum creatinine ≤ 1.5 x institutional ULN or an estimated glomerular filtration rate (eGFR) of > 50 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation.
Subject is suitable for oral administration of study drug.
Female subject must be either:
- Of non-child bearing potential:
- post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
- documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening)
- Or, if of childbearing potential,
- must agree not to try to become pregnant during the study and for 180 days after the final study drug administration, and
- must have a negative urine pregnancy test at Screening, and
- must use two forms of birth control* (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 180 days after the final study drug administration. *Acceptable forms of birth control include:

a. Established use of oral, injected or implanted hormonal methods of contraception.

b. Placement of an intrauterine device (IUD) or intrauterine system (IUS).

c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

Female subject must not be breastfeeding at Screening or during the study period, and for 60 days after the final study drug administration.
Female subject must not donate ova starting at Screening and throughout the study period, and for 180 days after the final study drug administration.
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control* (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 120 days after the final study drug administration.
Male subject must not donate sperm starting at Screening and throughout the study period and for 120 days after the final study drug administration.
Subject agrees not to participate in another interventional study while on treatment.

Exclusion Criteria

Subject was diagnosed as acute promyelocytic leukemia (APL) or AML with good risk cytogenetics; t(8;21), inv(16) or t(16;16). (Subjects with pending cytogenetics that require treatment may enroll. Any subject that is found to have good risk cytogenetics after initiation of treatment will discontinue ASP2215 and be taken off trial).
Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
Subject has active malignant tumors other than AML or myelodysplastic syndrome (MDS).
Subject has received previous therapy for AML, with the exception of the following:
- Emergency leukapheresis;
- Emergency treatment for hyperleukocytosis with hydroxyurea for ≤ 10 days;
- Preemptive treatment with retinoic acid prior to exclusion of APL ≤ 7 days;
- Growth factor or cytokine support;
- Steroids for the treatment of hypersensitivity or transfusion reactions.
Subject has clinically active central nervous system leukemia.
Subject has disseminated intravascular coagulation abnormality (DIC).
Subject has had major surgery within 4 weeks prior to the first study dose.
Subject has radiation therapy within 4 weeks prior to the first study dose.
Subject has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ≥ 45%.
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A.
Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.
Subject requires treatment with concomitant drugs that target serotonin 5HT1R or 5HT2BR receptors or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.
Subject has an active uncontrolled infection.
Subject is known to have human immunodeficiency virus infection.
Subject has active hepatitis B or C, or other active hepatic disorder.
Subject has any condition which makes the subject unsuitable for study participation (e.g. ophthalmic conditions such as advanced cataracts).
Subject has Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading.
Subject has Long corrected QT interval (QTc) Syndrome at Screening.
Subject has hypokalemia and hypomagnesemia at Screening (defined as values below institutional lower limit of normal [LLN]).

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A Study of ASP2215 in Combination with Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia

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