18 and older, any sex, with Hematologic Malignancy or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT)Primary· Cycle 1 (28-day cycle)
Occurrence of any of the following toxicities, attributable to ENTO, during Cycle 1 was considered DLT:
* Grade 4 non-hematologic toxicity except alopecia, nausea, and vomiting controllable with anti-emetic therapy, line associated venous thrombosis, infection-related toxicities such as fever/sepsis, and fatigue.
* In participants without bone marrow evidence of hematologic malignancy, hematologic toxicity defined as failure to recover absolute neutrophil count (ANC \> 500/μL) or platelet count (\>25000/μL) within 28 days
* Grade 4, clinically significant, electrolyte abnormalities that were
Group
Value
95% CI
ENTO 400 mg
0.0
Percentage of Participants With AEs and Laboratory Abnormalities Not Defined as DLTSecondary· Day 1 Up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Group
Value
95% CI
ENTO 400 mg
100.0
Plasma Concentration of ENTOSecondary· Cycle 1 (28-days cycle) Day 8 at 0 (predose), 1, 2, 3, 4, 6, 8, and 12 hours postdose
Plasma concentration of drug (ENTO) over different time points is reported.
Cycle 1 Day 8, predose
Group
Value
95% CI
ENTO 400 mg
921.9
± 610.47
Cycle 1 Day 8, 1 hour postdose
Group
Value
95% CI
ENTO 400 mg
1395.7
± 1081.40
Cycle 1 Day 8, 2 hours postdose
Group
Value
95% CI
ENTO 400 mg
1892.7
± 1285.08
Cycle 1 Day 8, 3 hours postdose
Group
Value
95% CI
ENTO 400 mg
1529.1
± 994.69
Cycle 1 Day 8, 4 hours postdose
Group
Value
95% CI
ENTO 400 mg
1350.0
± 862.21
Cycle 1 Day 8, 6 hours postdose
Group
Value
95% CI
ENTO 400 mg
1139.3
± 709.22
Cycle 1 Day 8, 8 hours postdose
Group
Value
95% CI
ENTO 400 mg
1075.9
± 659.08
Cycle 1 Day 8, 12 hours postdose
Group
Value
95% CI
ENTO 400 mg
855.1
± 568.18
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05020665 — Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML
· Phase 3
· terminated
NCT03225924 — Study of Entospletinib (ENTO) in Newly Diagnosed DLBCL Patients With aaIPI>=1 Treated by Chemiotherapy
· Phase 1, PHASE2
· terminated
NCT03010358 — Entospletinib and Obinutuzumab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lympho
· Phase 1, PHASE2
· completed
NCT02983617 — Safety and Efficacy of the Combination of Tirabrutinib and Entospletinib With and Without Obinutuzumab in Adults With Ch
· Phase 2
· completed
NCT02568683 — Safety and Efficacy of Entospletinib (ENTO [GS-9973]) Combined With Vincristine (VCR) in Adult Participants With Relapse
· Phase 1, PHASE2
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 6 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03135028.