Entospletinib (ENTO) as Monotherapy and in Combination With Chemotherapy in Japanese Adults

PHASE1TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

May 19, 2017

Primary Completion Date

February 26, 2019

Study Completion Date

February 26, 2019

Conditions
Hematologic MalignancyAcute Myeloid Leukemia
Interventions
DRUG

Entospletinib

400 mg (2 × 200 mg tablets) orally twice daily

DRUG

Daunorubicin

60 mg/m\^2 administered intravenously daily on Days 1 to 3 of each 28-day induction cycle

DRUG

Cytarabine

"100 mg/m\^2 intravenous administration twice daily on Days 1 to 7 of each 28-day induction cycle~Hi-DAC: 3 g/m\^2 IV administration twice daily on days 1, 3, and 5 (≤ 60 years of age) or 1 g/m\^2 IV administration once daily on Days 1 to 5 (\> 60 years of age) of each 28-day post-remission cycle"

Trial Locations (6)

910-1193

University of Fukui Hospital, Fukui

812-8582

Kyushu University Hospital, Fukuoka

259-1193

Tokai University Hospital, Kanagawa

980-8574

Tohoku University Hospital, Miyagi

589-8511

Kindai University Hospital, Ōsaka

141-8625

NTT Medical Center Tokyo, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY