NCT03150056 is a Phase 1 clinical trial of GSK525762 in Solid Tumours, sponsored by GlaxoSmithKline.

Who is sponsoring NCT03150056?

NCT03150056 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT03150056?

Interventions in NCT03150056: GSK525762, Abiraterone, Enzalutamide, Prednisone.

What condition does NCT03150056 study?

NCT03150056 studies Solid Tumours.

Is NCT03150056 still recruiting?

NCT03150056 is currently terminated. Last updated 10 August 2022.

Are results published for NCT03150056?

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

Last reviewed 2022-08-10 · How we verify

NCT03150056

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

Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer

Terminated Phase 1 Results posted Last updated 10 August 2022

What this trial tests

Phase 1 trial testing GSK525762 in Solid Tumours in 73 participants. Terminated before completion.

Timeline

18 July 2017

Primary endpoint
31 July 2020

22 June 2021

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	73
Start date	18 July 2017
Primary completion	31 July 2020
Estimated completion	22 June 2021
Sites	20 locations across United Kingdom, United States, Australia, Spain

Drugs / interventions tested

GSK525762
Abiraterone (ABIRATERONE) — full drug profile →
Enzalutamide (enzalutamide) — full drug profile →
Prednisone (prednisone) — full drug profile →

Conditions studied

Solid Tumours — all drugs for Solid Tumours →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, male only, with Solid Tumours. 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.

Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Primary · Up to 21.3 months

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An 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/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement, or is associated with liver injury and impaired liver function.

Any AEs

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	10
GSK525762 60 mg Alternate+Abiraterone 1000 mg	6
GSK525762 40 mg+Abiraterone 1000 mg	4
GSK525762 80 mg+Enzalutamide 160 mg	10
GSK525762 60 mg+Enzalutamide 160 mg	22
GSK525762 60 mg Alternate+Enzalutamide 160 mg	21

Any SAEs

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	4
GSK525762 60 mg Alternate+Abiraterone 1000 mg	2
GSK525762 40 mg+Abiraterone 1000 mg	0
GSK525762 80 mg+Enzalutamide 160 mg	1
GSK525762 60 mg+Enzalutamide 160 mg	6
GSK525762 60 mg Alternate+Enzalutamide 160 mg	7

Number of Participants With AEs Leading to Any Dose Reduction or Delays Primary · Up to 21.3 months

Dose reduction

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	4
GSK525762 60 mg Alternate+Abiraterone 1000 mg	1
GSK525762 40 mg+Abiraterone 1000 mg	0
GSK525762 80 mg+Enzalutamide 160 mg	7
GSK525762 60 mg+Enzalutamide 160 mg	10
GSK525762 60 mg Alternate+Enzalutamide 160 mg	7

Dose delay

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	5
GSK525762 60 mg Alternate+Abiraterone 1000 mg	2
GSK525762 40 mg+Abiraterone 1000 mg	4
GSK525762 80 mg+Enzalutamide 160 mg	8
GSK525762 60 mg+Enzalutamide 160 mg	15
GSK525762 60 mg Alternate+Enzalutamide 160 mg	12

Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment Primary · Up to 21.3 months

Number of participants who withdrew due to toxicity and changes in safety assessment including laboratory parameters and vital signs have been presented.

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	6
GSK525762 60 mg Alternate+Abiraterone 1000 mg	2
GSK525762 40 mg+Abiraterone 1000 mg	2
GSK525762 80 mg+Enzalutamide 160 mg	3
GSK525762 60 mg+Enzalutamide 160 mg	8
GSK525762 60 mg Alternate+Enzalutamide 160 mg	4

Percentage of Participants With Greater Than or Equals to (>=)50 Percent (%) Decrease in Prostate-specific Antigen From Baseline (PSA50) Primary · Up to 21.3 months

PSA50 response rate is defined as percentage of participants with a decrease of \>=50% in the PSA concentration from the Baseline PSA value determined at least 12 weeks after start of treatment and confirmed \>=4 weeks later by an additional PSA evaluation.

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	0	0.0 – 30.8
GSK525762 60 mg Alternate+Abiraterone 1000 mg	0	0.0 – 45.9
GSK525762 40 mg+Abiraterone 1000 mg	0	0.0 – 60.2
GSK525762 80 mg+Enzalutamide 160 mg	0	0.0 – 30.8
GSK525762 60 mg+Enzalutamide 160 mg	0	0.0 – 17.6
GSK525762 60 mg Alternate+Enzalutamide 160 mg	0	0.0 – 16.1

Maximum Observed Plasma Concentration (Cmax) of GSK525762 and Its Active Metabolites GSK3529246 Secondary · Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis. PK Population consisted of all participants from the All Treated Safety Population for whom a PK sample was obtained and analyzed.

GSK525762:Week1 Day1,n=10,6,4,10,21,18

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	950.319	± 19.18
GSK525762 60 mg Alternate+Abiraterone 1000 mg	993.154	± 33.77
GSK525762 40 mg+Abiraterone 1000 mg	671.129	± 30.44
GSK525762 80 mg+Enzalutamide 160 mg	427.580	± 31.76
GSK525762 60 mg+Enzalutamide 160 mg	333.256	± 48.86
GSK525762 60 mg Alternate+Enzalutamide 160 mg	336.296	± 43.28

GSK525762:Week3 Day1,n=4,3,3,9,17,10

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	891.302	± 36.79
GSK525762 60 mg Alternate+Abiraterone 1000 mg	735.171	± 21.63
GSK525762 40 mg+Abiraterone 1000 mg	559.711	± 40.59
GSK525762 80 mg+Enzalutamide 160 mg	284.298	± 45.12
GSK525762 60 mg+Enzalutamide 160 mg	158.409	± 153.45
GSK525762 60 mg Alternate+Enzalutamide 160 mg	171.527	± 47.88

GSK3529246:Week1 Day1,n=10,6,4,10,21,18

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	280.892	± 43.14
GSK525762 60 mg Alternate+Abiraterone 1000 mg	318.772	± 31.13
GSK525762 40 mg+Abiraterone 1000 mg	199.456	± 32.94
GSK525762 80 mg+Enzalutamide 160 mg	408.208	± 39.86
GSK525762 60 mg+Enzalutamide 160 mg	321.750	± 24.24
GSK525762 60 mg Alternate+Enzalutamide 160 mg	323.685	± 25.77

GSK3529246:Week3 Day1,n=4,3,3,10,17,10

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	447.929	± 39.30
GSK525762 60 mg Alternate+Abiraterone 1000 mg	444.232	± 26.74
GSK525762 40 mg+Abiraterone 1000 mg	364.151	± 15.46
GSK525762 80 mg+Enzalutamide 160 mg	449.614	± 49.54
GSK525762 60 mg+Enzalutamide 160 mg	328.398	± 39.74
GSK525762 60 mg Alternate+Enzalutamide 160 mg	356.615	± 18.26

Time to Cmax (Tmax) of GSK525762 and Its Active Metabolites GSK3529246 Secondary · Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis.

GSK525762:Week1 Day1,n=10,6,4,10,21,18

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	0.800	0.50 – 2.92
GSK525762 60 mg Alternate+Abiraterone 1000 mg	0.558	0.50 – 1.00
GSK525762 40 mg+Abiraterone 1000 mg	1.000	0.58 – 3.08
GSK525762 80 mg+Enzalutamide 160 mg	0.508	0.40 – 1.08
GSK525762 60 mg+Enzalutamide 160 mg	1.000	0.45 – 3.00
GSK525762 60 mg Alternate+Enzalutamide 160 mg	0.742	0.50 – 6.00

GSK525762:Week3 Day1,n=4,3,3,9,17,10

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	0.500	0.50 – 0.50
GSK525762 60 mg Alternate+Abiraterone 1000 mg	1.000	0.50 – 3.00
GSK525762 40 mg+Abiraterone 1000 mg	0.950	0.50 – 1.00
GSK525762 80 mg+Enzalutamide 160 mg	0.583	0.47 – 3.00
GSK525762 60 mg+Enzalutamide 160 mg	0.933	0.00 – 3.03
GSK525762 60 mg Alternate+Enzalutamide 160 mg	0.517	0.50 – 3.08

GSK3529246:Week1 Day1,n=10,6,4,10,21,18

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	3.000	1.18 – 6.00
GSK525762 60 mg Alternate+Abiraterone 1000 mg	3.000	0.53 – 6.00
GSK525762 40 mg+Abiraterone 1000 mg	2.042	1.00 – 3.08
GSK525762 80 mg+Enzalutamide 160 mg	2.067	1.00 – 3.00
GSK525762 60 mg+Enzalutamide 160 mg	2.917	0.53 – 6.05
GSK525762 60 mg Alternate+Enzalutamide 160 mg	1.817	0.95 – 6.00

GSK3529246:Week3 Day1,n=4,3,3,10,17,10

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	1.000	0.85 – 3.00
GSK525762 60 mg Alternate+Abiraterone 1000 mg	3.000	1.00 – 6.17
GSK525762 40 mg+Abiraterone 1000 mg	3.000	1.00 – 3.03
GSK525762 80 mg+Enzalutamide 160 mg	1.042	0.50 – 6.00
GSK525762 60 mg+Enzalutamide 160 mg	1.017	0.00 – 6.00
GSK525762 60 mg Alternate+Enzalutamide 160 mg	1.875	0.50 – 6.33

Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUC[0-tau]) of GSK525762 and Its Active Metabolites GSK3529246 Secondary · Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis.

GSK525762:Week1 Day1,n=8,2,2,6,9,8

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	4927.834	± 71.78
GSK525762 60 mg Alternate+Abiraterone 1000 mg	4677.411	± 21.59
GSK525762 40 mg+Abiraterone 1000 mg	4172.282	± 31.08
GSK525762 80 mg+Enzalutamide 160 mg	1139.481	± 34.32
GSK525762 60 mg+Enzalutamide 160 mg	1261.529	± 102.14
GSK525762 60 mg Alternate+Enzalutamide 160 mg	959.452	± 60.97

GSK525762:Week3 Day1,n=4,1,3,5,6,6

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	2697.923	± 69.10
GSK525762 60 mg Alternate+Abiraterone 1000 mg	2580.877	± NA
GSK525762 40 mg+Abiraterone 1000 mg	1561.908	± 13.67
GSK525762 80 mg+Enzalutamide 160 mg	674.437	± 57.10
GSK525762 60 mg+Enzalutamide 160 mg	660.607	± 14.41
GSK525762 60 mg Alternate+Enzalutamide 160 mg	386.950	± 37.03

GSK3529246:Week1 Day1,n=2,1,0,5,9,10

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	3765.196	± 0.47
GSK525762 60 mg Alternate+Abiraterone 1000 mg	4918.549	± NA
GSK525762 80 mg+Enzalutamide 160 mg	4379.342	± 30.76
GSK525762 60 mg+Enzalutamide 160 mg	3373.990	± 19.73
GSK525762 60 mg Alternate+Enzalutamide 160 mg	3306.018	± 31.84

GSK3529246:Week3 Day1,n=2,2,2,4,12,7

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	4170.516	± 6.55
GSK525762 60 mg Alternate+Abiraterone 1000 mg	5146.749	± 9.99
GSK525762 40 mg+Abiraterone 1000 mg	4598.235	± 16.28
GSK525762 80 mg+Enzalutamide 160 mg	3816.407	± 37.02
GSK525762 60 mg+Enzalutamide 160 mg	3386.702	± 30.44
GSK525762 60 mg Alternate+Enzalutamide 160 mg	3082.516	± 33.36

Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246 Secondary · Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis.

GSK525762:Week1 Day1,n=8,2,3,1,3,4

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	22.418	± 192.37
GSK525762 60 mg Alternate+Abiraterone 1000 mg	8.696	± 72.93
GSK525762 40 mg+Abiraterone 1000 mg	13.664	± 119.83
GSK525762 80 mg+Enzalutamide 160 mg	2.100	± NA
GSK525762 60 mg+Enzalutamide 160 mg	5.053	± 3035.92
GSK525762 60 mg Alternate+Enzalutamide 160 mg	1.660	± 34.60

GSK525762:Week3 Day1,n=2,2,2,1,0,0

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	8.966	± 93.46
GSK525762 60 mg Alternate+Abiraterone 1000 mg	4.555	± 522.90
GSK525762 40 mg+Abiraterone 1000 mg	1.410	± 48.34
GSK525762 80 mg+Enzalutamide 160 mg	3.540	± NA

GSK3529246:Week1 Day1,n=8,3,3,9,20,17

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	58.995	± 52.50
GSK525762 60 mg Alternate+Abiraterone 1000 mg	68.379	± 47.51
GSK525762 40 mg+Abiraterone 1000 mg	42.107	± 52.26
GSK525762 80 mg+Enzalutamide 160 mg	46.011	± 38.73
GSK525762 60 mg+Enzalutamide 160 mg	37.765	± 56.41
GSK525762 60 mg Alternate+Enzalutamide 160 mg	38.200	± 53.15

GSK3529246:Week3 Day1,n=3,3,2,7,13,8

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	48.223	± 99.09
GSK525762 60 mg Alternate+Abiraterone 1000 mg	48.291	± 29.86
GSK525762 40 mg+Abiraterone 1000 mg	63.526	± 3.90
GSK525762 80 mg+Enzalutamide 160 mg	50.882	± 77.10
GSK525762 60 mg+Enzalutamide 160 mg	32.299	± 60.18
GSK525762 60 mg Alternate+Enzalutamide 160 mg	26.165	± 76.95

Cmax of Abiraterone Secondary · Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis.

Week 1 Day 1, n=10,5,4

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	77.962	± 57.07
GSK525762 60 mg Alternate+Abiraterone 1000 mg	63.369	± 114.31
GSK525762 40 mg+Abiraterone 1000 mg	122.496	± 131.30

Week 3 Day 1, n=4,4,2

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	149.673	± 65.39
GSK525762 60 mg Alternate+Abiraterone 1000 mg	87.554	± 110.92
GSK525762 40 mg+Abiraterone 1000 mg	146.924	± 76.98

Tmax of Abiraterone Secondary · Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis.

Week 1 Day 1, n=10,5,4

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	1.133	0.17 – 3.13
GSK525762 60 mg Alternate+Abiraterone 1000 mg	1.083	0.53 – 3.00
GSK525762 40 mg+Abiraterone 1000 mg	0.750	0.00 – 1.08

Week 3 Day 1, n=4,4,2

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	1.000	0.85 – 1.00
GSK525762 60 mg Alternate+Abiraterone 1000 mg	2.000	0.98 – 3.00
GSK525762 40 mg+Abiraterone 1000 mg	3.017	3.00 – 3.03

AUC(0-tau) of Abiraterone Secondary · Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis.

Week 1 Day 1, n=5,1,1

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	432.368	± 56.74
GSK525762 60 mg Alternate+Abiraterone 1000 mg	148.871	± NA
GSK525762 40 mg+Abiraterone 1000 mg	1405.809	± NA

Week 3 Day 1, n=1,2,1

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	1361.627	± NA
GSK525762 60 mg Alternate+Abiraterone 1000 mg	595.686	± 64.72
GSK525762 40 mg+Abiraterone 1000 mg	2185.039	± NA

Ctrough of Abiraterone Secondary · Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis.

Week 1 Day 1, n=9,2,3

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	7.603	± 93.00
GSK525762 60 mg Alternate+Abiraterone 1000 mg	4.636	± 1802.64
GSK525762 40 mg+Abiraterone 1000 mg	11.263	± 86.21

Week 3 Day 1, n=2,4,1

Group	Value	95% CI
GSK525762 60 mg+Abiraterone 1000 mg	15.114	± 9.84
GSK525762 60 mg Alternate+Abiraterone 1000 mg	7.697	± 69.99
GSK525762 40 mg+Abiraterone 1000 mg	21.800	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK525762 60 mg+Abiraterone 1000 mg

Serious: 4/10 (40%)

Deaths: 9/10

GSK525762 60 mg Alternate+Abiraterone 1000 mg

Serious: 2/6 (33%)

Deaths: 2/6

GSK525762 40 mg+Abiraterone 1000 mg

Serious: 0/4 (0%)

Deaths: 2/4

GSK525762 80 mg+Enzalutamide 160 mg

Serious: 1/10 (10%)

Deaths: 7/10

GSK525762 60 mg+Enzalutamide 160 mg

Serious: 6/22 (27%)

Deaths: 8/22

GSK525762 60 mg Alternate+Enzalutamide 160 mg

Serious: 7/21 (33%)

Deaths: 10/21

Serious adverse events (27 terms)

Reaction	System	GSK525762 60 mg+Abirateron…	GSK525762 60 mg Alternate+…	GSK525762 40 mg+Abirateron…	GSK525762 80 mg+Enzalutami…	GSK525762 60 mg+Enzalutami…	GSK525762 60 mg Alternate+…
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Clavicle fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Disseminated intravascular coagulation	Blood and lymphatic system disorders	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Femur fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—
Gastric haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Intraventricular haemorrhage	Nervous system disorders	—	—	—	—	—	—
Myelitis	Infections and infestations	—	—	—	—	—	—
Myocarditis	Cardiac disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Paraplegia	Nervous system disorders	—	—	—	—	—	—
Pathological fracture	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Rectal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—
Renal impairment	Renal and urinary disorders	—	—	—	—	—	—
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Subdural haemorrhage	Injury, poisoning and procedural complications	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—

Other adverse events (40 terms — click to expand)

Reaction	System	GSK525762 60 mg+Abirateron…	GSK525762 60 mg Alternate+…	GSK525762 40 mg+Abirateron…	GSK525762 80 mg+Enzalutami…	GSK525762 60 mg+Enzalutami…	GSK525762 60 mg Alternate+…
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Amylase increased	Investigations	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—	—
Troponin I increased	Investigations	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Hypertriglyceridaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
International normalised ratio increased	Investigations	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Haematoma	Vascular disorders	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—

Most-reported serious reactions: Acute kidney injury, Haematuria, Back pain, Clavicle fracture, Dehydration, Diarrhoea, Disseminated intravascular coagulation, Epistaxis.

Data from ClinicalTrials.gov NCT03150056 adverse events section.

Sponsor's own description

This study aims to evaluate the combination of GSK525762 with other agents that have been shown to be effective in the treatment of CRPC or metastatic (m)CRPC. This study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) based on safety, tolerability, pharmacokinetic, and efficacy profiles of GSK525762 in combination with either abiraterone (Arm A) or enzalutamide (Arm B).

Publications & conference data

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

Targeting epigenetic regulators for cancer therapy: mechanisms and advances in clinical trials.
Cheng Y, He C, Wang M, Ma X, et al · · 2019 · cited 760× · PMID 31871779 · DOI 10.1038/s41392-019-0095-0
The liver cancer immune microenvironment: Therapeutic implications for hepatocellular carcinoma.
Donne R, Lujambio A. · · 2023 · cited 461× · PMID 35989535 · DOI 10.1002/hep.32740
Epigenetic regulation in human cancer: the potential role of epi-drug in cancer therapy.
Lu Y, Chan YT, Tan HY, Li S, et al · · 2020 · cited 318× · PMID 32340605 · DOI 10.1186/s12943-020-01197-3
Targeting signaling pathways in prostate cancer: mechanisms and clinical trials.
He Y, Xu W, Xiao YT, Huang H, et al · · 2022 · cited 192× · PMID 35750683 · DOI 10.1038/s41392-022-01042-7
Epigenetics-targeted drugs: current paradigms and future challenges.
Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
Bromodomain and extraterminal (BET) proteins: biological functions, diseases, and targeted therapy.
Wang ZQ, Zhang ZC, Wu YY, Pi YN, et al · · 2023 · cited 128× · PMID 37926722 · DOI 10.1038/s41392-023-01647-6
Recent developments in epigenetic cancer therapeutics: clinical advancement and emerging trends.
Nepali K, Liou JP. · · 2021 · cited 122× · PMID 33840388 · DOI 10.1186/s12929-021-00721-x
Targeting Bromodomain and Extraterminal Proteins for Drug Discovery: From Current Progress to Technological Development.
Tang P, Zhang J, Liu J, Chiang CM, et al · · 2021 · cited 109× · PMID 33616410 · DOI 10.1021/acs.jmedchem.0c01487

Verify or expand the search:

Other trials of GSK525762

Trials testing the same drug.

NCT02964507 — Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-p · Phase 1 · terminated
NCT01943851 — A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of · Phase 2 · completed
NCT01587703 — A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects Wi · Phase 1 · completed

Other recruiting trials for Solid Tumours

Currently open trials in the same condition.

NCT07391670 — A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durval · Phase 1 · recruiting
NCT07446855 — Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homo · Phase 1, PHASE2 · recruiting
NCT07224425 — A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it · Phase 1 · recruiting
NCT07165067 — A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
NCT07403370 — Olanzapine Dose Comparison for the Prevention of HER-INV: A Network Meta-Analysis · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

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 NCT03150056 (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: 10 August 2022

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/NCT03150056.

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

NCT03150056

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (27 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of GSK525762

Other recruiting trials for Solid Tumours

Other GlaxoSmithKline trials

Verify against primary sources