Clinical trial NCT03135028: Entospletinib (ENTO) as Monotherapy and in Combination With Chemotherapy in Japanese Adults
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hematologic Malignancy
Acute Myeloid Leukemia
Keywords: Relapsed or Refractory Hematologic Malignancy
Previously untreated AML
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2017-05-01
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Key Inclusion Criteria:

* ENTO monotherapy (Group A): relapsed or refractory hematologic malignancies by World Health Organisation (WHO) criteria and who are not eligible to receive standard of care
* ENTO + cytarabine + daunorubicin (Group B): previously untreated AML by WHO criteria, who are deemed fit for cytarabine and daunorubicin (7+3) induction chemotherapy and are able to undergo up to 2 cycles of induction chemotherapy, as determined by the treating physician
* Must have been born in Japan and must not have lived outside of Japan for a period \> 1 year in the 5 years prior to Day 1 of study treatment
* Must be able to confirm the Japanese origin of their maternal and paternal ancestry

Key Exclusion Criteria:

* Known active central nervous system or leptomeningeal leukemic involvement
* Ongoing liver injury, or known infection with chronic active hepatitis C virus (HCV) or chronic active hepatitis B virus (HBV)

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT)
timeFrame: Cycle 1 (28-day cycle)
Secondary outcomes:
measure: Percentage of Participants With AEs and Laboratory Abnormalities Not Defined as DLT
timeFrame: Day 1 Up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
measure: Plasma Concentration of ENTO
timeFrame: Cycle 1 (28-days cycle) Day 8 at 0 (predose), 1, 2, 3, 4, 6, 8, and 12 hours postdose
Other outcomes:
Locations:
city: Fukui
country: Japan
facility: University of Fukui Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Miyagi
country: Japan
facility: Tohoku University Hospital
city: Tokyo
country: Japan
facility: NTT Medical Center Tokyo
city: Ōsaka
country: Japan
facility: Kindai University Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: