Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

265

Participants

Timeline

Start Date

October 9, 2013

Primary Completion Date

August 4, 2017

Study Completion Date

March 7, 2018

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Gilteritinib

Participants received gilteritinib oral tablets (10 mg, 40 mg or 100 mg, depending on the dose) once daily without food allowed for at least 2 hours before and 1 hour after dosing starting from day -2 and day of cycle 1, for continuous 28-day cycles.

DRUG

Voriconazole

Participants received 200 mg voriconazole tablets daily every 12 hours starting from day 16 of cycle 1 through day 1 of cycle 2.

DRUG

Midazolam

Participants received a single oral dose of 2 mg of midazolam syrup on day -1 and day 15 of cycle 1.

DRUG

Cephalexin

Participants received a single oral dose of 500 mg cephalexin tablet or capsule on day -1 and day 15 of cycle 1.

Trial Locations (26)

10022

Site US10009, New York

10032

Site US10013, New York

10065

Site US10019, New York

12203

Site DE49002, Berlin

14263

Site US10010, Buffalo

17033

Site US10018, Hershey

19104

Site US10004, Philadelphia

21201

Site US10012, Baltimore

21287

Site US10003, Baltimore

22031

Site US10026, Fairfax

35294

Site US10021, Birmingham

37232

Site US10007, Nashville

40138

Site IT39001, Bologna

44195

Site US10014, Cleveland

55455

Site US10006, Minneapolis

55905

Site US10011, Rochester

60611

Site US10001, Chicago

60637

Site US10015, Chicago

77030

Site US10002, Houston

85259

Site US10023, Scottsdale

91010

Site US10022, Duarte

94143

Site US10005, San Francisco

90095-1678

Site US10008, Los Angeles

07601

Site US10020, Hackensack

29425-8900

Site US10017, Charleston

01307

Site DE49004, Dresden

All Listed Sponsors
lead

Astellas Pharma Global Development, Inc.

INDUSTRY

NCT02014558 - Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter