Trial · NCT03150056

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

NCT03150056, Phase 1, Terminated, GlaxoSmithKline; results first posted 2021-08-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer. Trials, record NCT03150056. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03150056

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer
NCT number: NCT03150056
Status: Terminated
Phases: Phase 1
Enrollment: 73 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Solid Tumours
Interventions: GSK525762, Abiraterone, Enzalutamide, Prednisone
First posted: 2017-05-11
Last updated: 2022-08-10
Other registries' IDs: eudract:2016-003416-13
Results first posted: 2021-08-26

Source ClinicalTrials.gov

Registered outcomes29

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.
Primary	Number of Participants With AEs Leading to Any Dose Reduction or Delays	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. Number of participants with AEs leading to any dose reduction or delays have been presented.
Primary	Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment	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.
Primary	Percentage of Participants With Greater Than or Equals to (>=)50 Percent (%) Decrease in Prostate-specific Antigen From Baseline (PSA50)	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.
Secondary	Maximum Observed Plasma Concentration (Cmax) of GSK525762 and Its Active Metabolites GSK3529246	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.
Secondary	Time to Cmax (Tmax) of GSK525762 and Its Active Metabolites GSK3529246	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.
Secondary	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	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.
Secondary	Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246	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.
Secondary	Cmax of Abiraterone	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.
Secondary	Tmax of Abiraterone	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.

1 to 10 of 29Source ClinicalTrials.gov

See all 29 registered outcomes

Outcomes29

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to 21.3 months	All Treated Population consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With AEs Leading to Any Dose Reduction or Delays	Up to 21.3 months	All Treated Population.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment	Up to 21.3 months	All Treated Population.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Percentage of Participants With Greater Than or Equals to (>=)50 Percent (%) Decrease in Prostate-specific Antigen From Baseline (PSA50)	Up to 21.3 months	Modified All Treated Population comprised of all participants who received at least one dose of GSK525762 plus abiraterone/enzalutamide. Only those participants with data available at the indicated time points were analyzed.	Percentage of participants	NUMBER
SECONDARY	Maximum Observed Plasma Concentration (Cmax) of GSK525762 and Its Active Metabolites GSK3529246	Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3	PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).	Nanogram per milliliter	GEOMETRIC_MEAN
SECONDARY	Time to Cmax (Tmax) of GSK525762 and Its Active Metabolites GSK3529246	Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3	PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).	Hours	MEDIAN
SECONDARY	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	Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3	PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).	Hours*nanogram per milliliter	GEOMETRIC_MEAN
SECONDARY	Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246	Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3	PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).	Nanogram per milliliter	GEOMETRIC_MEAN
SECONDARY	Cmax of Abiraterone	Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3	PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).	Nanogram per milliliter	GEOMETRIC_MEAN
SECONDARY	Tmax of Abiraterone	Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3	PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).	Hours	MEDIAN

1 to 10 of 29Source ClinicalTrials.gov

See all 29 outcomes

Results by group430

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	GSK525762 60 mg+Abiraterone 1000 mg	Any AEs	10	Participants
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	GSK525762 60 mg Alternate+Abiraterone 1000 mg	Any AEs	6	Participants
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	GSK525762 40 mg+Abiraterone 1000 mg	Any AEs	4	Participants
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	GSK525762 80 mg+Enzalutamide 160 mg	Any AEs	10	Participants
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	GSK525762 60 mg+Enzalutamide 160 mg	Any AEs	22	Participants
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	GSK525762 60 mg Alternate+Enzalutamide 160 mg	Any AEs	21	Participants
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	GSK525762 60 mg+Abiraterone 1000 mg	Any SAEs	4	Participants
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	GSK525762 60 mg Alternate+Abiraterone 1000 mg	Any SAEs	2	Participants
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	GSK525762 40 mg+Abiraterone 1000 mg	Any SAEs	0	Participants
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	GSK525762 80 mg+Enzalutamide 160 mg	Any SAEs	1	Participants

1 to 10 of 430Source ClinicalTrials.gov

See all 430 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	GSK525762 60 mg+Abiraterone 1000 mg	10
Overall Study	STARTED	GSK525762 60 mg Alternate+Abiraterone 1000 mg	6
Overall Study	STARTED	GSK525762 40 mg+Abiraterone 1000 mg	4
Overall Study	STARTED	GSK525762 80 mg+Enzalutamide 160 mg	10
Overall Study	STARTED	GSK525762 60 mg+Enzalutamide 160 mg	22
Overall Study	STARTED	GSK525762 60 mg Alternate+Enzalutamide 160 mg	21
Overall Study	COMPLETED	GSK525762 60 mg+Abiraterone 1000 mg	0
Overall Study	COMPLETED	GSK525762 60 mg Alternate+Abiraterone 1000 mg	1
Overall Study	COMPLETED	GSK525762 40 mg+Abiraterone 1000 mg	1
Overall Study	COMPLETED	GSK525762 80 mg+Enzalutamide 160 mg	2

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events402

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Decreased appetite	Metabolism and nutrition disorders	GSK525762 60 mg+Abiraterone 1000 mg	4	10	4
other	Decreased appetite	Metabolism and nutrition disorders	GSK525762 60 mg Alternate+Abiraterone 1000 mg	4	6	4
other	Decreased appetite	Metabolism and nutrition disorders	GSK525762 40 mg+Abiraterone 1000 mg	4	4	6
other	Decreased appetite	Metabolism and nutrition disorders	GSK525762 80 mg+Enzalutamide 160 mg	4	10	6
other	Decreased appetite	Metabolism and nutrition disorders	GSK525762 60 mg+Enzalutamide 160 mg	9	22	15
other	Decreased appetite	Metabolism and nutrition disorders	GSK525762 60 mg Alternate+Enzalutamide 160 mg	13	21	15
other	Nausea	Gastrointestinal disorders	GSK525762 60 mg+Abiraterone 1000 mg	7	10	9
other	Nausea	Gastrointestinal disorders	GSK525762 60 mg Alternate+Abiraterone 1000 mg	3	6	3
other	Nausea	Gastrointestinal disorders	GSK525762 40 mg+Abiraterone 1000 mg	1	4	2
other	Nausea	Gastrointestinal disorders	GSK525762 80 mg+Enzalutamide 160 mg	6	10	7

1 to 10 of 402Source ClinicalTrials.gov

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Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GSK525762 60 mg+Abiraterone 1000 mg	9	10
Total, all-cause mortality	GSK525762 60 mg Alternate+Abiraterone 1000 mg	2	6
Total, all-cause mortality	GSK525762 40 mg+Abiraterone 1000 mg	2	4
Total, all-cause mortality	GSK525762 80 mg+Enzalutamide 160 mg	7	10
Total, all-cause mortality	GSK525762 60 mg+Enzalutamide 160 mg	8	22
Total, all-cause mortality	GSK525762 60 mg Alternate+Enzalutamide 160 mg	10	21
Total, other adverse events	GSK525762 60 mg+Abiraterone 1000 mg	10	10
Total, other adverse events	GSK525762 60 mg Alternate+Abiraterone 1000 mg	6	6
Total, other adverse events	GSK525762 40 mg+Abiraterone 1000 mg	4	4
Total, other adverse events	GSK525762 80 mg+Enzalutamide 160 mg	10	10

1 to 10 of 18Source ClinicalTrials.gov

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Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03150056

GET https://conductscience.org/api/trials/v1/NCT03150056/registered?page=2

API reference For AI assistants