NCT02343939 (ENTO in AML) is a Phase 1, PHASE2 clinical trial of Entospletinib in Acute Myeloid Leukemia, sponsored by Gilead Sciences.

Who is sponsoring NCT02343939?

NCT02343939 is sponsored by Gilead Sciences.

What drugs are being tested in NCT02343939?

Interventions in NCT02343939: Entospletinib, Daunorubicin, Cytarabine, Decitabine, Azacitidine.

What condition does NCT02343939 study?

NCT02343939 studies Acute Myeloid Leukemia.

Is NCT02343939 still recruiting?

NCT02343939 is currently terminated. Last updated 15 November 2019.

Are results published for NCT02343939?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-11-15 · How we verify

NCT02343939: ENTO in AML

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML)

Terminated Phase 1, PHASE2 Results posted Last updated 15 November 2019

What this trial tests

Phase 1, PHASE2 trial testing Entospletinib in Acute Myeloid Leukemia in 148 participants. Terminated before completion.

Timeline

1 July 2015

Primary endpoint
4 September 2018

21 February 2019

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	148
Start date	1 July 2015
Primary completion	4 September 2018
Estimated completion	21 February 2019
Sites	17 locations across Canada, United States, Germany

Drugs / interventions tested

Entospletinib
Daunorubicin (daunorubicin) — full drug profile →
Cytarabine — full drug profile →
Decitabine (decitabine) — full drug profile →
Azacitidine (azacitidine) — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

Gilead Sciences — full company profile →

Who can join

18 and older, any sex, with 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 Experiencing Dose Limiting Toxicities (DLTs) Primary · Group A: Cycle 0 Day 1 to Cycle 2 Day 28; Group B: Cycle 0 Day 1 to Cycle 1 Day 28; Group C: Cycle 1 Day 1 to Cycle 1 Day 28 (Cycle length: for Cycle 0 = 14 days, for all other cycles = 28 days)

DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment. DLT assessment was applicable only for Phase 1b and Phase 2 safety run-in participants.

Group	Value	95% CI
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin	0
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin	0
Group B Phase 1b ENTO 200 mg + Decitabine	0
Group B Phase 1b ENTO 400 mg + Decitabine	16.7
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)	0
Group C Phase 1b/2 ENTO 400 mg	0
Group C Phase 1b ENTO 800 mg	16.7

Percentage of Participants With Morphologic Complete Remission (CR) at the End of Induction Primary · At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)

Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Morphologic CR included CR and cytogenetic CR (CRc). CR required all of the following: \< 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/microliter (mcL); Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis.

Group	Value	95% CI
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin	66.7	9.4 – 99.2
Group A Phase 1b ENTO 400 mg + Cytarabine + Daunorubicin	66.7	29.9 – 92.5
Group A Phase 2 ENTO 400 mg + Cytarabine + Daunorubicin	46.3	30.7 – 62.6
Group B Phase 1b ENTO 200 mg + Decitabine	0.0	0.0 – 52.2
Group B Phase 1b ENTO 400 mg + Decitabine	16.7	0.4 – 64.1
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)	25.0	3.2 – 65.1
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)	0.0	0.0 – 19.5
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)	7.1	0.2 – 33.9
Group C Phase 1b ENTO 400 mg	0.0	0.0 – 41.0
Group C Phase 1b ENTO 800 mg	0.0	0.0 – 41.0
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)	0.0	0.0 – 45.9
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)	15.4	1.9 – 45.4

Percentage of Participants With Composite Complete Remission at the End of Induction Primary · At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)

Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Composite complete remission included CR, CRc, and morphologic complete remission with incomplete blood count recovery (CRi). CR required all of the following: \< 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis. CRi required all of the CR cri

Group	Value	95% CI
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin	100.0	29.2 – 100
Group A Phase 1b ENTO 400 mg + Cytarabine + Daunorubicin	77.8	40 – 97.2
Group A Phase 2 ENTO 400 mg + Cytarabine + Daunorubicin	65.9	49.4 – 79.9
Group B Phase 1b ENTO 200 mg + Decitabine	40.0	5.3 – 85.3
Group B Phase 1b ENTO 400 mg + Decitabine	50.0	11.8 – 88.2
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)	25.0	3.2 – 65.1
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)	23.5	6.8 – 49.9
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)	14.3	1.8 – 42.8
Group C Phase 1b ENTO 400 mg	14.3	0.4 – 57.9
Group C Phase 1b ENTO 800 mg	0.0	0.0 – 41.0
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)	0.0	0.0 – 45.9
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)	15.4	1.9 – 45.4

Percentage of Participants With Overall Response at the End of Induction Primary · At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)

Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Overall response included CR, CRc, CRi, and partial remission (PR). CR required all of the following: \< 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis. CRi required all of the CR criteria except the criterion of neutrophils and platelets. P

Group	Value	95% CI
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin	100.0	29.2 – 100
Group A Phase 1b ENTO 400 mg + Cytarabine + Daunorubicin	77.8	40 – 97.2
Group A Phase 2 ENTO 400 mg + Cytarabine + Daunorubicin	70.7	54.5 – 83.9
Group B Phase 1b ENTO 200 mg + Decitabine	40.0	5.3 – 85.3
Group B Phase 1b ENTO 400 mg + Decitabine	50.0	11.8 – 88.2
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)	25.0	3.2 – 65.1
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)	23.5	6.8 – 49.9
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)	14.3	1.8 – 42.8
Group C Phase 1b ENTO 400 mg	14.3	0.4 – 57.9
Group C Phase 1b ENTO 800 mg	0.0	0 – 41
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)	0.0	0 – 45.9
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)	15.4	1.9 – 45.4

Duration of Exposure of Entospletinib Secondary · First dose date up to approximately 3 years

Group	Value	95% CI
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin	8.6	6.1 – 10.0
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin	7.1	0.9 – 72.9
Group B Phase 1b ENTO 200 mg + Decitabine	13.7	1.6 – 50.9
Group B Phase 1b ENTO 400 mg + Decitabine	15.4	1.9 – 58.9
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)	10.1	1.3 – 39.4
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)	13.9	1.9 – 40.0
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)	10.1	0.9 – 47.0
Group C Phase 1b/2 ENTO 400 mg	4.4	1.4 – 15.6
Group C Phase 1b ENTO 800 mg	7.6	2.0 – 9.0

Event Free Survival (EFS) Secondary · First dose date up to approximately 38 months

EFS was defined as the time interval from the start of the study therapy until the date of treatment failure, acute myeloid leukemia (AML) relapse, or death from any cause, whichever occurred first. Participants who received other anti-cancer therapy (prior to the event if any) were censored. Median EFS was analyzed using Kaplan-Meier (KM) method.

Group	Value	95% CI
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin	NA	NA – NA
Group A Phase 1b ENTO 400 mg + Cytarabine + Daunorubicin	1.9	0.9 – 1.9
Group A Phase 2 ENTO 400 mg + Cytarabine + Daunorubicin	9.0	2.3 – NA
Group B Phase 1b ENTO 200 mg + Decitabine	2.2	0.5 – 4.7
Group B Phase 1b ENTO 400 mg + Decitabine	2.9	1.1 – 7.7
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)	2.3	0.5 – 9.0
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)	3.2	0.5 – 4.2
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)	2.4	2.1 – 3.9
Group C Phase 1b ENTO 400 mg	1.8	0.9 – 1.9
Group C Phase 1b ENTO 800 mg	1.8	0.5 – 1.9
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)	1.0	0.7 – 2.8
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)	1.0	0.8 – 2.7

Overall Survival (OS) Secondary · First dose date up to approximately 38 months

OS was defined as the time interval from the start of the study therapy to death from any cause. Median OS was analyzed using KM method.

Group	Value	95% CI
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin	37.1	9.1 – NA
Group A Phase 1b ENTO 400 mg + Cytarabine + Daunorubicin	34.1	1.2 – NA
Group A Phase 2 ENTO 400 mg + Cytarabine + Daunorubicin	NA	16.8 – NA
Group B Phase 1b ENTO 200 mg + Decitabine	3.2	0.8 – 12.7
Group B Phase 1b ENTO 400 mg + Decitabine	5.3	2.4 – NA
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)	6.9	1.4 – NA
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)	7.3	2.4 – NA
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)	6.2	3.2 – 10.2
Group C Phase 1b ENTO 400 mg	5.9	0.9 – 6.3
Group C Phase 1b ENTO 800 mg	5.6	0.5 – 8.4
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)	8.2	0.7 – 24.3
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)	7.9	3.3 – 11.9

Percentage of Participants Experiencing Treatment-Emergent Adverse Events Secondary · First dose date up to the last dose date plus 30 days (maximum: 18 months)

Group	Value	95% CI
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin	100.0
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin	100.0
Group B Phase 1b ENTO 200 mg + Decitabine	100.0
Group B Phase 1b ENTO 400 mg + Decitabine	100.0
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)	100.0
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)	100.0
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)	100.0
Group C Phase 1b/2 ENTO 400 mg	100.0
Group C Phase 1b ENTO 800 mg	100.0

Percentage of Participants Who Experienced Laboratory Abnormalities Secondary · First dose date up to the last dose date plus 30 days (maximum: 18 months)

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.

Any Laboratory Abnormality

Group	Value	95% CI
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin	100
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin	100
Group B Phase 1b ENTO 200 mg + Decitabine	100
Group B Phase 1b ENTO 400 mg + Decitabine	100
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)	100
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)	94.1
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)	100
Group C Phase 1b/2 ENTO 400 mg	100
Group C Phase 1b ENTO 800 mg	100

Grade 3 or 4 Laboratory Abnormalities

Group	Value	95% CI
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin	100
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin	98.0
Group B Phase 1b ENTO 200 mg + Decitabine	100
Group B Phase 1b ENTO 400 mg + Decitabine	100
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)	85.7
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)	94.1
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)	92.9
Group C Phase 1b/2 ENTO 400 mg	82.9
Group C Phase 1b ENTO 800 mg	85.7

Adverse events — posted to ClinicalTrials.gov

Time frame: - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin

Serious: 0/3 (0%)

Deaths: 2/3

Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin

Serious: 23/50 (46%)

Deaths: 21/50

Group B Phase 1b ENTO 200 mg + Decitabine

Serious: 5/5 (100%)

Deaths: 5/5

Group B Phase 1b ENTO 400 mg + Decitabine

Serious: 5/6 (83%)

Deaths: 4/6

Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)

Serious: 7/8 (88%)

Deaths: 5/8

Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)

Serious: 11/17 (65%)

Deaths: 12/17

Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)

Serious: 7/14 (50%)

Deaths: 11/14

Group C Phase 1b/2 ENTO 400 mg

Serious: 19/35 (54%)

Deaths: 30/35

Group C Phase 1b ENTO 800 mg

Serious: 4/7 (57%)

Deaths: 6/7

Serious adverse events (74 terms)

Reaction	System	Group A Phase 1b ENTO 200 …	Group A Phase 1b/2 ENTO 40…	Group B Phase 1b ENTO 200 …	Group B Phase 1b ENTO 400 …	Group B Phase 2 ENTO 400 m…	Group B Phase 2 ENTO 400 m…	Group B Phase 2 ENTO 400 m…	Group C Phase 1b/2 ENTO 40…	Group C Phase 1b ENTO 800 mg
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—	—	—	—	—
Haematemesis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Lung infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—
Angina pectoris	Cardiac disorders	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—
Cardiac failure chronic	Cardiac disorders	—	—	—	—	—	—	—	—	—
Sinus bradycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Gastric haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Haematochezia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Intestinal ischaemia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Large intestine perforation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Oesophagitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Proctalgia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—

Other adverse events (287 terms — click to expand)

Reaction	System	Group A Phase 1b ENTO 200 …	Group A Phase 1b/2 ENTO 40…	Group B Phase 1b ENTO 200 …	Group B Phase 1b ENTO 400 …	Group B Phase 2 ENTO 400 m…	Group B Phase 2 ENTO 400 m…	Group B Phase 2 ENTO 400 m…	Group C Phase 1b/2 ENTO 40…	Group C Phase 1b ENTO 800 mg
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—
Lung infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—	—	—
Mucosal inflammation	General disorders	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Febrile neutropenia, Cardiac failure congestive, Haematemesis, Pyrexia, Device related infection, Lung infection, Pneumonia, Sepsis.

Data from ClinicalTrials.gov NCT02343939 adverse events section.

Sponsor's own description

This study will evaluate the efficacy, safety, and tolerability of entospletinib when administered as monotherapy or in combination with chemotherapy in adults with acute myeloid leukemia (AML).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Syk inhibitors in clinical development for hematological malignancies.
Liu D, Mamorska-Dyga A. · · 2017 · cited 130× · PMID 28754125 · DOI 10.1186/s13045-017-0512-1
Current status and future perspectives in targeted therapy of NPM1-mutated AML.
Ranieri R, Pianigiani G, Sciabolacci S, Perriello VM, et al · · 2022 · cited 91× · PMID 36008542 · DOI 10.1038/s41375-022-01666-2
Targeting Tyrosine Kinases in Acute Myeloid Leukemia: Why, Who and How?
Fernandez S, Desplat V, Villacreces A, Guitart AV, et al · · 2019 · cited 34× · PMID 31336846 · DOI 10.3390/ijms20143429
Inhibitors of Chemoresistance Pathways in Combination with Ara-C to Overcome Multidrug Resistance in AML. A Mini Review.
Fajardo-Orduña GR, Ledesma-Martínez E, Aguiñiga-Sánchez I, Mora-García ML, et al · · 2021 · cited 27× · PMID 34066940 · DOI 10.3390/ijms22094955
Combinatorial efficacy of entospletinib and chemotherapy in patient-derived xenograft models of infant acute lymphoblastic leukemia.
Loftus JP, Yahiaoui A, Brown PA, Niswander LM, et al · · 2021 · cited 22× · PMID 32414848 · DOI 10.3324/haematol.2019.241729
The rocky road to personalized medicine in acute myeloid leukaemia.
Brinda B, Khan I, Parkin B, Konig H. · · 2018 · cited 15× · PMID 29327808 · DOI 10.1111/jcmm.13478
Acute Myeloid Leukemia: From Biology to Clinical Practices Through Development and Pre-Clinical Therapeutics.
Roussel X, Daguindau E, Berceanu A, Desbrosses Y, et al · · 2020 · cited 14× · PMID 33363031 · DOI 10.3389/fonc.2020.599933
Entospletinib with decitabine in acute myeloid leukemia with mutant TP53 or complex karyotype: A phase 2 substudy of the Beat AML Master Trial.
Duong VH, Ruppert AS, Mims AS, Borate U, et al · · 2023 · cited 13× · PMID 37078412 · DOI 10.1002/cncr.34780

Verify or expand the search:

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Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting

Other Gilead Sciences trials

Trials by the same sponsor.

NCT07115368 — Study of GS-1219 in Participants With HIV-1 · Phase 1 · terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain · completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated · Phase 2, PHASE3 · terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02343939 (US National Library of Medicine, public domain)
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: 15 November 2019

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/NCT02343939.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing