NCT03135028

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

A Phase 1b Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Entospletinib (ENTO) as Monotherapy in Japanese Subjects With Relapsed or Refractory Hematologic Malignancies and in Combination With Chemotherapy in Japanese Subjects With Previously Untreated Acute Myeloid Leukemia (AML)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of entospletinib (ENTO) monotherapy and in combination with chemotherapy in Japanese participants.

Conditions

• Hematologic Malignancy
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-05-19
• Primary completion: 2019-02-26
• Completion: 2019-02-26
• First posted: 2017-05-01
• Last updated: 2020-03-06
• Results posted: 2020-03-06

Locations

6 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study