NCT02177812 is a Phase 1 clinical trial of GSK2879552 in Leukaemia, Myelocytic, Acute, sponsored by GlaxoSmithKline.

Who is sponsoring NCT02177812?

NCT02177812 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT02177812?

Interventions in NCT02177812: GSK2879552, ATRA.

What condition does NCT02177812 study?

NCT02177812 studies Leukaemia, Myelocytic, Acute.

Is NCT02177812 still recruiting?

NCT02177812 is currently terminated. Last updated 28 June 2019.

Are results published for NCT02177812?

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

Last reviewed 2019-06-28 · How we verify

NCT02177812

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

A Phase I Dose Escalation Study of GSK2879552 in Subjects With Acute Myeloid Leukemia (AML)

Terminated Phase 1 Results posted Last updated 28 June 2019

What this trial tests

Phase 1 trial testing GSK2879552 in Leukaemia, Myelocytic, Acute in 41 participants. Terminated before completion.

Timeline

27 August 2014

Primary endpoint
8 December 2017

8 December 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	27 August 2014
Primary completion	8 December 2017
Estimated completion	8 December 2017
Sites	8 locations across Canada, United States, Australia

Drugs / interventions tested

GSK2879552 — full drug profile →
ATRA — full drug profile →

Conditions studied

Leukaemia, Myelocytic, Acute — all drugs for Leukaemia, Myelocytic, Acute →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Leukaemia, Myelocytic, Acute. 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.

Part 1: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) Primary · Median of 4 weeks of drug exposure

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function.

All AEs

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	2
Part 1: GSK2879552 4mg QD	7
Part 1: GSK2879552 8mg QD	5
Part 1: GSK2879552 12mg QD	6
Part 1: GSK2879552 20mg QD	4
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	10
Part 1: GSK2879552 20mg QD PK/PD Expansion	6

All SAEs

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	2
Part 1: GSK2879552 4mg QD	7
Part 1: GSK2879552 8mg QD	5
Part 1: GSK2879552 12mg QD	6
Part 1: GSK2879552 20mg QD	3
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	8
Part 1: GSK2879552 20mg QD PK/PD Expansion	5

Part 1: Number of Participants With Dose Limiting Toxicities (DLT) Primary · Median of 4 weeks of drug exposure

An event was considered a DLT if it occursed within the first 28 days of treatment, and meets one of the following criteria unless it can be clearly established that the event was unrelated to treatment: hematologic DLT included myelosuppression, Grade \>=3 non-hematologic toxicity that is considered clinically significant and lasts \>72 hours, Grade 2 toxicity that in the judgment of the investigator and GSK Medical Monitor is dose-limiting and treatment delay of \>=42 days due to unresolved toxicity.

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	0
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Part 1: Number of Participants With AE Leading to Dose Reductions or Delays Primary · Median of 4 weeks of drug exposure

The number of participants who had any dose reduction or delay have been presented.

AEs leading to dose reduction

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	0
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	0
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	1

AEs leading to dose interruption/delay

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	2
Part 1: GSK2879552 8mg QD	3
Part 1: GSK2879552 12mg QD	5
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	6
Part 1: GSK2879552 20mg QD PK/PD Expansion	1

Part 1: Number of Participants With Withdrawals Due to Toxicities Primary · Median of 4 weeks of drug exposure

Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented.

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	0
Part 1: GSK2879552 8mg QD	1
Part 1: GSK2879552 12mg QD	4
Part 1: GSK2879552 20mg QD	2
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	4
Part 1: GSK2879552 20mg QD PK/PD Expansion	2

Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range Primary · Median of 4 weeks of drug exposure

Blood samples were collected to assess clinical chemistry parameters like urea/blood urea nitrogen (BUN), calcium, potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, glucose, total carbon dioxide (CO2), gamma glutamyl transferase (GGT), albumin, sodium, alkaline phosphatase, total protein, phosphate, lactate dehydrogenase (LDH). Laboratory values were as per local labs per site with own normal ranges. Values above range were reported as high and values below range as low. Data for worst case post Base

Direct Bilirubin,to Low,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	0
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	0
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Direct Bilirubin,to High,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	2
Part 1: GSK2879552 8mg QD	1
Part 1: GSK2879552 12mg QD	2
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	5
Part 1: GSK2879552 20mg QD PK/PD Expansion	3

Chloride,to Low,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	0
Part 1: GSK2879552 8mg QD	1
Part 1: GSK2879552 12mg QD	2
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	2
Part 1: GSK2879552 20mg QD PK/PD Expansion	1

Chloride,to High,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	1
Part 1: GSK2879552 4mg QD	2
Part 1: GSK2879552 8mg QD	1
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

CO2/Bicarbonate,to Low,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	1
Part 1: GSK2879552 8mg QD	1
Part 1: GSK2879552 12mg QD	2
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	2
Part 1: GSK2879552 20mg QD PK/PD Expansion	2

CO2/Bicarbonate,to High,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	1
Part 1: GSK2879552 8mg QD	2
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	1

Lactate Dehydrogenase,to Low,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	2
Part 1: GSK2879552 8mg QD	2
Part 1: GSK2879552 12mg QD	2
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	2
Part 1: GSK2879552 20mg QD PK/PD Expansion	2

Lactate Dehydrogenase,to High,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	2
Part 1: GSK2879552 8mg QD	1
Part 1: GSK2879552 12mg QD	2
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	3
Part 1: GSK2879552 20mg QD PK/PD Expansion	2

Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline Primary · Median of 4 weeks of drug exposure

Blood samples were collected for analysis of clinical chemistry parameters based on common terminology criteria for adverse events (CTCAE) version 4.0, where Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life threatening consequences. Data for any increase in grade of worst-case on-therapy has been provided.

Albumin, n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	2
Part 1: GSK2879552 4mg QD	5
Part 1: GSK2879552 8mg QD	3
Part 1: GSK2879552 12mg QD	4
Part 1: GSK2879552 20mg QD	4
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	6
Part 1: GSK2879552 20mg QD PK/PD Expansion	3

ALP, n=1,2,7,5,6,4, 10, 6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	3
Part 1: GSK2879552 8mg QD	2
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	3
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

ALT, n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	4
Part 1: GSK2879552 8mg QD	3
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	1
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	5
Part 1: GSK2879552 20mg QD PK/PD Expansion	2

AST, n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	2
Part 1: GSK2879552 4mg QD	3
Part 1: GSK2879552 8mg QD	2
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	1
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	3
Part 1: GSK2879552 20mg QD PK/PD Expansion	1

Total bilirubin, n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	1
Part 1: GSK2879552 4mg QD	2
Part 1: GSK2879552 8mg QD	1
Part 1: GSK2879552 12mg QD	3
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	4
Part 1: GSK2879552 20mg QD PK/PD Expansion	2

Hypercalcemia, n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	0
Part 1: GSK2879552 8mg QD	2
Part 1: GSK2879552 12mg QD	0
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	3
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Hypoglycemia,n= 1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	1
Part 1: GSK2879552 8mg QD	2
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	1
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Creatinine,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	1
Part 1: GSK2879552 4mg QD	2
Part 1: GSK2879552 8mg QD	1
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	4
Part 1: GSK2879552 20mg QD PK/PD Expansion	1

Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Primary · Median of 4 weeks of drug exposure

Blood samples were collected to assess hematology parameters like mean corpuscle hemoglobin concentration (MCHC), mean corpuscle hemoglobin (MCH), mean corpuscle volume (MCV) mean platelet volume (MPV), basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, monocytes, platelet count, Red blood cell (RBC) count, reticulocytes, White Blood Cell (WBC) count. Laboratory values were as per local labs per site with own normal ranges. Values above range were reported as high and values below range as low. Data for worst post Baseline were reported. NA indicates that data were not available as s

Basophils, to Low,n=1,2,7,4,2,2,9,5

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	2
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	0
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Basophils, to High,n=1,2,7,4,2,2,9,5

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	1
Part 1: GSK2879552 8mg QD	2
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Eosinophils, to Low,n=1,2,7,4,2,2,8,5

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	2
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Eosinophils, to High,n=1,2,7,4,2,2,8,5

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	1
Part 1: GSK2879552 4mg QD	1
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	0
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	1

Hemoglobin, to Low,n=0,0,0,0,2,0,0,1

Group	Value	95% CI
Part 1: GSK2879552 12mg QD	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Hemoglobin, to High,n=0,0,0,0,2,0,0,1

Group	Value	95% CI
Part 1: GSK2879552 12mg QD	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	1

Hematocrit, to Low,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	0
Part 1: GSK2879552 8mg QD	1
Part 1: GSK2879552 12mg QD	0
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Hematocrit, to High,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	0
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	0
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Number of Participants With Hematology Toxicity Grade Changes From Baseline Primary · Median of 4 weeks of drug exposure

Blood samples were collected for analysis of hematology parameters based on common terminology criteria for adverse events (CTCAE) version 4.0, where Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life threatening consequences. Data for any grade increase worst-case on-therapy has been provided.

Hg increase,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	0
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	0
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Hg anemia,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	2
Part 1: GSK2879552 4mg QD	5
Part 1: GSK2879552 8mg QD	4
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	2
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	4
Part 1: GSK2879552 20mg QD PK/PD Expansion	3

Lymph increase,n=1,2,7,4,2,2,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	1
Part 1: GSK2879552 4mg QD	1
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	0
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	3
Part 1: GSK2879552 20mg QD PK/PD Expansion	1

Lymph decrease,n=1,2,7,4,2,2,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	2
Part 1: GSK2879552 4mg QD	2
Part 1: GSK2879552 8mg QD	3
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	2
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	5
Part 1: GSK2879552 20mg QD PK/PD Expansion	2

Total Neu,n=1,2,7,4,2,2,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	2
Part 1: GSK2879552 4mg QD	1
Part 1: GSK2879552 8mg QD	1
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	1
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	1
Part 1: GSK2879552 20mg QD PK/PD Expansion	1

Platelet,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	1
Part 1: GSK2879552 4mg QD	4
Part 1: GSK2879552 8mg QD	3
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	2
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	3
Part 1: GSK2879552 20mg QD PK/PD Expansion	3

WBC,n=1,2,7,5,6,4,10,6

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	2
Part 1: GSK2879552 4mg QD	2
Part 1: GSK2879552 8mg QD	4
Part 1: GSK2879552 12mg QD	5
Part 1: GSK2879552 20mg QD	1
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	5
Part 1: GSK2879552 20mg QD PK/PD Expansion	1

Part 1: Number of Participants With Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Primary · Median of 4 weeks of drug exposure

SBP and DBP were measured after resting for 5 minutes in semi-supine position. Vital signs were graded according to Common Toxicity Criteria for Adverse Events (CTCAE) version 4. An increase is defined as an increase in CTCAE grade relative to Baseline grade. For SBP Grade 0 (\<120 millimeters of mercury \[mmHg\]), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP Grade 0 (\<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Data for worst-case post Baseline is reported.

SBP,Any Grade Increase; n=1, 1, 3, 4, 6, 2, 5, 3

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	1
Part 1: GSK2879552 4mg QD	3
Part 1: GSK2879552 8mg QD	4
Part 1: GSK2879552 12mg QD	6
Part 1: GSK2879552 20mg QD	2
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	5
Part 1: GSK2879552 20mg QD PK/PD Expansion	3

SBP,Increase to Grade 2;n=1, 1, 3, 4, 6, 2, 5, 3

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	1
Part 1: GSK2879552 4mg QD	1
Part 1: GSK2879552 8mg QD	2
Part 1: GSK2879552 12mg QD	2
Part 1: GSK2879552 20mg QD	1
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	4
Part 1: GSK2879552 20mg QD PK/PD Expansion	3

SBP,Increase to Grade 3;n=1, 1, 3, 4, 6, 2, 5, 3

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	0
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	2
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

DBP,Any Grade Increase;n=1, 2, 3, 2, 4, 1, 3, 2

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	2
Part 1: GSK2879552 4mg QD	3
Part 1: GSK2879552 8mg QD	2
Part 1: GSK2879552 12mg QD	4
Part 1: GSK2879552 20mg QD	1
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	3
Part 1: GSK2879552 20mg QD PK/PD Expansion	2

DBP,Increase to Grade 2;n=1, 2, 3, 2, 4, 1, 3, 2

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	1
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	2
Part 1: GSK2879552 20mg QD	1
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	2
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

DBP,Increase to Grade 3;n=1, 2, 3, 2, 4, 1, 3, 2

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	0
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	0
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Part 1: Number of Participants With Change From Baseline in Heart Rate Primary · Median of 4 weeks of drug exposure

Heart rate was measured after restings for 5 minutes in semi-supine position. Data for participants with heart rate decreased to \< 60 beats per minute (bpm), normal or no change, increase to \> 100 bpm. Data for worst post Baseline were reported.

Decrease to <60

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	1
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Change to Normal or No Change

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	2
Part 1: GSK2879552 4mg QD	1
Part 1: GSK2879552 8mg QD	4
Part 1: GSK2879552 12mg QD	4
Part 1: GSK2879552 20mg QD	4
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	5
Part 1: GSK2879552 20mg QD PK/PD Expansion	3

Increase to >100

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	6
Part 1: GSK2879552 8mg QD	1
Part 1: GSK2879552 12mg QD	2
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	5
Part 1: GSK2879552 20mg QD PK/PD Expansion	3

Part 1: Number of Participants With Change From Baseline in Temperature Primary · Median of 4 weeks of drug exposure

Temperature was measured after resting for 5 minutes in semi-supine position. Data for participants with temperature decreased to \<=35 Celsius, normal or no change, increase to \>=38 Celsius at worst-case post Baseline is reported.

Decrease to <=35

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	1
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	0
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Change to Normal or No Change

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	1
Part 1: GSK2879552 2mg QD	2
Part 1: GSK2879552 4mg QD	4
Part 1: GSK2879552 8mg QD	4
Part 1: GSK2879552 12mg QD	5
Part 1: GSK2879552 20mg QD	4
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	9
Part 1: GSK2879552 20mg QD PK/PD Expansion	6

Increase to >=38

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	3
Part 1: GSK2879552 8mg QD	1
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	1
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Part 1: Number of Participants With Change From Baseline in Respiratory Rate Primary · Median of 4 weeks of drug exposure

Respiration rate was measured after resting for 5 minutes in semi-supine position. Data for worst case post-Baseline has been reported. Number of participants with respiratory rate decrease to \<12 and increase to \>25 has been reported.

Decrease to <12

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	0
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	0
Part 1: GSK2879552 20mg QD	1
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	0
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Increase to >25

Group	Value	95% CI
Part 1:GSK2879552 1mg QD	0
Part 1: GSK2879552 2mg QD	0
Part 1: GSK2879552 4mg QD	2
Part 1: GSK2879552 8mg QD	0
Part 1: GSK2879552 12mg QD	1
Part 1: GSK2879552 20mg QD	0
Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day	1
Part 1: GSK2879552 20mg QD PK/PD Expansion	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from start of the study up to 3 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1:GSK2879552 1mg QD

Serious: 1/1 (100%)

Deaths: 0/1

Part 1: GSK2879552 2mg QD

Serious: 2/2 (100%)

Deaths: 0/2

Part 1: GSK2879552 4mg QD

Serious: 7/7 (100%)

Deaths: 1/7

Part 1: GSK2879552 8mg QD

Serious: 5/5 (100%)

Deaths: 0/5

Part 1: GSK2879552 12mg QD

Serious: 6/6 (100%)

Deaths: 3/6

Part 1: GSK2879552 20mg QD

Serious: 3/4 (75%)

Deaths: 1/4

Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day

Serious: 8/10 (80%)

Deaths: 2/10

Part 1: GSK2879552 20mg QD PK/PD Expansion

Serious: 5/6 (83%)

Deaths: 1/6

Part 2: Expansion Cohort

Serious: 0

Deaths: 0

Serious adverse events (44 terms)

Reaction	System	Part 1:GSK2879552 1mg QD	Part 1: GSK2879552 2mg QD	Part 1: GSK2879552 4mg QD	Part 1: GSK2879552 8mg QD	Part 1: GSK2879552 12mg QD	Part 1: GSK2879552 20mg QD	Part 1: GSK2879552 2mg QD/…	Part 1: GSK2879552 20mg QD…	Part 2: Expansion Cohort
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—
Anorectal cellulitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Escherichia sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—	—
Klebsiella bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—
Lung infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Pseudomonal bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—
Parainfluenzae virus infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Pneumonia respiratory syncytial viral	Infections and infestations	—	—	—	—	—	—	—	—	—
Pulmonary mycosis	Infections and infestations	—	—	—	—	—	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—	—	—	—	—	—
Soft tissue infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Viral infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Gastric haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Oral pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—

Other adverse events (204 terms — click to expand)

Reaction	System	Part 1:GSK2879552 1mg QD	Part 1: GSK2879552 2mg QD	Part 1: GSK2879552 4mg QD	Part 1: GSK2879552 8mg QD	Part 1: GSK2879552 12mg QD	Part 1: GSK2879552 20mg QD	Part 1: GSK2879552 2mg QD/…	Part 1: GSK2879552 20mg QD…	Part 2: Expansion Cohort
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Confusional state	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Fluid overload	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—	—	—	—
Petechiae	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—	—	—	—
Mouth ulceration	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Oral pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Localised oedema	General disorders	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—
Psoriasis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Rash pruritic	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Tachypnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Lung infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—
Lethargy	Nervous system disorders	—	—	—	—	—	—	—	—	—
Disturbance in attention	Nervous system disorders	—	—	—	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Febrile neutropenia, Anaemia, Leukocytosis, Thrombocytopenia, Cellulitis, Pneumonia, Anorectal cellulitis, Escherichia sepsis.

Data from ClinicalTrials.gov NCT02177812 adverse events section.

Sponsor's own description

This study is a phase I, open-label study to determine recommended phase 2 dose (RP2D) and regimen for the orally administered lysine specific demethylase 1 (LSD1) inhibitor GSK2879552, alone or in combination with All-Trans Retinoic Acid (ATRA). The recommended dose and regimen will be selected based on the safety, pharmacokinetic (PK), and pharmacodynamic (PD) profiles observed after the treatment of subjects with relapsed/refractory AML. The study consists of two parts. Part 1 will identify the maximum tolerated dose (MTD) and/or RP2D using a dose-escalation procedure. Dose escalations will be guided by the Neuenschwander-continual reassessment method (N-CRM). PK/PD expansion cohorts will also be included in Part 1 to characterize the range of biologically effective doses by assessing PD markers and obtain additional PK data. Part 2 will explore further the safety, tolerability, and clinical activity of GSK2879552, alone or in combination with ATRA, at the RP2D in subjects with AML.

Publications & conference data

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

Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
LSD1/KDM1A inhibitors in clinical trials: advances and prospects.
Fang Y, Liao G, Yu B, Yu B. · · 2019 · cited 316× · PMID 31801559 · DOI 10.1186/s13045-019-0811-9
MLL-Rearranged Leukemias-An Update on Science and Clinical Approaches.
Winters AC, Bernt KM. · · 2017 · cited 289× · PMID 28232907 · DOI 10.3389/fped.2017.00004
Epigenetics in cancer stem cells.
Toh TB, Lim JJ, Chow EK. · · 2017 · cited 286× · PMID 28148257 · DOI 10.1186/s12943-017-0596-9
Targeting histone methyltransferases and demethylases in clinical trials for cancer therapy.
Morera L, Lübbert M, Jung M. · · 2016 · cited 283× · PMID 27222667 · DOI 10.1186/s13148-016-0223-4
Epigenetics and Cancer Stem Cells: Unleashing, Hijacking, and Restricting Cellular Plasticity.
Wainwright EN, Scaffidi P. · · 2017 · cited 250× · PMID 28718414 · DOI 10.1016/j.trecan.2017.04.004
Targeting epigenetic regulators to overcome drug resistance in cancers.
Wang N, Ma T, Yu B, Yu B. · · 2023 · cited 213× · PMID 36797239 · DOI 10.1038/s41392-023-01341-7
Genomic and Epigenomic Alterations in Cancer.
Chakravarthi BV, Nepal S, Varambally S. · · 2016 · cited 149× · PMID 27338107 · DOI 10.1016/j.ajpath.2016.02.023

Verify or expand the search:

Other trials of GSK2879552

Trials testing the same drug.

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Trials by the same sponsor.

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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 NCT02177812 (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 GlaxoSmithKline
Last refreshed: 28 June 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/NCT02177812.

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