Trial · NCT02964507

Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer

NCT02964507, Phase 1, Terminated, GlaxoSmithKline; results first posted 2022-01-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer. Trials, record NCT02964507. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02964507

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Trial

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

Title: Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer
NCT number: NCT02964507
Status: Terminated
Phases: Phase 1
Enrollment: 124 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Neoplasms
Interventions: GSK525762, Placebo, Fulvestrant
First posted: 2016-11-16
Last updated: 2024-08-29
Other registries' IDs: eudract:2016-003074-40
Results first posted: 2022-01-27

Source ClinicalTrials.gov

Registered outcomes19

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

List	Outcome	Time frame	Description
Primary	Phase I: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to 3 year and 8 months	An AE is defined as 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. A 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 such as important medical events according to medical or scientific judgement or is associated with liver injury and impaired liver function. Any other adverse event apart from SAE is considered as non-SAE.
Primary	Phase I: Number of Participants With Dose Limiting Toxicities (DLTs)	Up to 28 days	An event was considered DLT if it occurred within first 28 days of treatment and met one of following DLT criteria: Grade3 or greater neutropenia for \>=5 days, febrile neutropenia, Grade4 anemia of any duration, Grade4 thrombocytopenia of any duration or Grade3 thrombocytopenia with bleeding, alanine aminotransferase (ALT) \>3 times (x) upper limit of normal (ULN)+bilirubin \>=2x ULN (\>35 % direct) or ALT between 3-5xULN with bilirubin \<2xULN but with hepatitis symptoms or rash, Grade3 nausea,vomiting or diarrhea that did not improve within 72hour despite appropriate supportive treatment(s), Grade4 nausea,vomiting,or diarrhea, Grade3 hypertension (uncontrolled despite addition of upto 2 antihypertensive medications), Grade4 hypertension, other Grade3 or greater clinically significant non-hematologic toxicity (including QT duration corrected for heart rate by Fridericia's formula (QTcF), ejection fraction \<lower limit of normal (LLN) with an absolute decrease of \>10% from Baseline.
Primary	Phase I: Number of Participants With Dose Reductions and Dose Interruption/Delays	Up to 3 year and 8 months	Number of participants with dose reductions and dose interruption or delay due to any reason is presented.
Primary	Phase I: Objective Response Rate-Investigator Assessment	Up to 3 year and 8 months	Objective Response Rate is defined as the percentage of participants who demonstrate a Best Response of confirmed complete response (CR) or partial response (PR), as assessed by the investigator per response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria.
Primary	Phase I: Plasma Concentration of GSK525762	Day 1: Pre-dose, 0.5, 1, 3 hours on Weeks 1 and 3; Day 1: Pre-dose, 0.5-1, 4-8 hours on Week 5; Day 1: Pre-dose, 0.5-1 hour on Weeks 9, 17, 25	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK525762.
Primary	Phase II: Progression Free Survival (PFS)	Up to 3 year and 8 months	PFS is defined as the time (in months) from the date of first dose until the date of first documented progressive disease (PD), as assessed by the investigator per RECIST v1.1 criteria, or date of death due to any cause, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions taking as a reference the smallest sum of diameters for this study.
Secondary	Phase I: Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment	Up to 4 year and 4 months	Number of participants who withdrew due to toxicity and changes in safety assessment including laboratory parameters and vital signs have been presented.
Secondary	Phase I: Disease Control Rate (DCR)	Up to 3 year and 8 months	DCR is defined as the percentage of participants in the population with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) lasting \>=6 months, as assessed by the investigator per RECIST v1.1 criteria.
Secondary	Phase I: Duration of Response (DoR)	Up to 3 year and 8 months	DoR is defined as the time (in months) from date of first documented evidence of confirmed CR or PR to the date of first documented PD, as assessed by the investigator per RECIST v1.1 criteria, or to the date of death due to any cause among participants with a Best overall response (BOR) of confirmed CR or PR.
Secondary	Phase I: Progression-free Survival (PFS)	Up to 3 year and 8 months	PFS is defined as the time (in months) from the date of first dose until the date of first documented PD, as assessed by the investigator per RECIST v1.1 criteria, or date of death due to any cause, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions taking as a reference the smallest sum of diameters for this study.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Phase I: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to 3 year and 8 months	All Treated Population consisted of participants who received at least one dose of study treatment (GSK525762 or fulvestrant).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Phase I: Number of Participants With Dose Limiting Toxicities (DLTs)	Up to 28 days	All Treated Population.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Phase I: Number of Participants With Dose Reductions and Dose Interruption/Delays	Up to 3 year and 8 months	All Treated Population.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Phase I: Objective Response Rate-Investigator Assessment	Up to 3 year and 8 months	Modified All Treated Population consisted of all participants who received at least one dose of GSK525762 and fulvestrant.	Percentage of participants	NUMBER
PRIMARY	Phase I: Plasma Concentration of GSK525762	Day 1: Pre-dose, 0.5, 1, 3 hours on Weeks 1 and 3; Day 1: Pre-dose, 0.5-1, 4-8 hours on Week 5; Day 1: Pre-dose, 0.5-1 hour on Weeks 9, 17, 25	PK Population comprised of participants from the All Treated Population for whom a PK sample was obtained and analyzed. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).	Nanograms per milliliter	MEAN
PRIMARY	Phase II: Progression Free Survival (PFS)	Up to 3 year and 8 months	Modified All Treated Population. Phase II of study was not initiated hence data was not collected and analyzed.
SECONDARY	Phase I: Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment	Up to 4 year and 4 months	All Treated Population.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Phase I: Disease Control Rate (DCR)	Up to 3 year and 8 months	Modified All Treated Population.	Percentage of participants	NUMBER
SECONDARY	Phase I: Duration of Response (DoR)	Up to 3 year and 8 months	Modified All Treated Population. Only those participants with a BOR of confirmed CR or PR based on RECIST v1.1 were analyzed hence N=0 for Phase I-GSK525762 60 mg+FUL 500 mg (CDK4/6+AI Failure \<12M) and Phase I-GSK525762 60+FUL500mg CDK4/6+AI Failure\>=12M Bone Only Disease arms.	Months	MEDIAN
SECONDARY	Phase I: Progression-free Survival (PFS)	Up to 3 year and 8 months	Modified All Treated Population.	Months	MEDIAN

1 to 10 of 19Source ClinicalTrials.gov

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Results by group318

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

Outcome	Group	Category	Value	Units
Phase I: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)	Phase I-GSK525762 60 mg+FUL 500 mg (AI Failure)	Non-serious AEs	33	Participants
Phase I: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)	Phase I-GSK525762 60 mg+FUL 500 mg (CDK4/6+AI Failure <12M)	Non-serious AEs	12	Participants
Phase I: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)	Phase I-GSK525762 60 mg+FUL 500 mg (CDK4/6+ AI Failure >= 12M)	Non-serious AEs	42	Participants
Phase I: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)	Phase I-GSK525762 60+FUL500mg CDK4/6+AI Failure>=12M Bone Only Disease	Non-serious AEs	7	Participants
Phase I: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)	Phase I-GSK525762 80mg + FUL 500 mg (AI Failure)	Non-serious AEs	18	Participants
Phase I: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)	Phase I-GSK525762 80 mg + FUL 500 mg (CDK4/6+AI Failure)	Non-serious AEs	11	Participants
Phase I: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)	Phase I-GSK525762 60 mg+FUL 500 mg (AI Failure)	SAEs	5	Participants
Phase I: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)	Phase I-GSK525762 60 mg+FUL 500 mg (CDK4/6+AI Failure <12M)	SAEs	1	Participants
Phase I: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)	Phase I-GSK525762 60 mg+FUL 500 mg (CDK4/6+ AI Failure >= 12M)	SAEs	10	Participants
Phase I: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)	Phase I-GSK525762 60+FUL500mg CDK4/6+AI Failure>=12M Bone Only Disease	SAEs	3	Participants

1 to 10 of 318Source ClinicalTrials.gov

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Participant flow24

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase I-GSK525762 60 mg+FUL 500 mg (AI Failure)	33
Overall Study	STARTED	Phase I-GSK525762 60 mg+FUL 500 mg (CDK4/6+AI Failure <12M)	12
Overall Study	STARTED	Phase I-GSK525762 60 mg+FUL 500 mg (CDK4/6+ AI Failure >= 12M)	42
Overall Study	STARTED	Phase I-GSK525762 60+FUL500mg CDK4/6+AI Failure>=12M Bone Only Disease	7
Overall Study	STARTED	Phase I-GSK525762 80mg + FUL 500 mg (AI Failure)	18
Overall Study	STARTED	Phase I-GSK525762 80 mg + FUL 500 mg (CDK4/6+AI Failure)	11
Overall Study	STARTED	Phase II-GSK525762+FUL	0
Overall Study	STARTED	Phase II-Placebo+FUL	0
Overall Study	COMPLETED	Phase I-GSK525762 60 mg+FUL 500 mg (AI Failure)	7
Overall Study	COMPLETED	Phase I-GSK525762 60 mg+FUL 500 mg (CDK4/6+AI Failure <12M)	1

1 to 10 of 24Source ClinicalTrials.gov

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Adverse events808

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	Nausea	Gastrointestinal disorders	Phase I- GSK525762 60mg+FUL 500mg (AI Failure)	12	33	17
other	Nausea	Gastrointestinal disorders	Phase I-GSK525762 60mg+FUL 500mg (CDK4/6+AI Failure < 12M)	7	12	10
other	Nausea	Gastrointestinal disorders	Phase I-GSK525762 60mg+FUL 500mg (CDK4/6+AI Failure >=12M)	30	42	38
other	Nausea	Gastrointestinal disorders	Phase I-GSK525762 60mg+FUL 500mg (CDK4/6+AI Failure >=12M Bone Only Disease	5	7	9
other	Nausea	Gastrointestinal disorders	Phase I-GSK525762 80mg+FUL 500mg (AI Failure)	11	18	21
other	Nausea	Gastrointestinal disorders	Phase I-GSK525762 80mg+FUL 500mg (CDK4/6+AI Failure)	9	11	9
other	Nausea	Gastrointestinal disorders	Phase II-GSK525762 +FUL	0	0	0
other	Nausea	Gastrointestinal disorders	Phase II-Placebo+FUL	0	0	0
other	Fatigue	General disorders	Phase I- GSK525762 60mg+FUL 500mg (AI Failure)	19	33	24
other	Fatigue	General disorders	Phase I-GSK525762 60mg+FUL 500mg (CDK4/6+AI Failure < 12M)	4	12	6

1 to 10 of 808Source ClinicalTrials.gov

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Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase I- GSK525762 60mg+FUL 500mg (AI Failure)	11	33
Total, all-cause mortality	Phase I-GSK525762 60mg+FUL 500mg (CDK4/6+AI Failure < 12M)	9	12
Total, all-cause mortality	Phase I-GSK525762 60mg+FUL 500mg (CDK4/6+AI Failure >=12M)	12	42
Total, all-cause mortality	Phase I-GSK525762 60mg+FUL 500mg (CDK4/6+AI Failure >=12M Bone Only Disease	2	7
Total, all-cause mortality	Phase I-GSK525762 80mg+FUL 500mg (AI Failure)	10	18
Total, all-cause mortality	Phase I-GSK525762 80mg+FUL 500mg (CDK4/6+AI Failure)	5	11
Total, all-cause mortality	Phase II-GSK525762 +FUL	0	0
Total, all-cause mortality	Phase II-Placebo+FUL	0	0
Total, other adverse events	Phase I- GSK525762 60mg+FUL 500mg (AI Failure)	33	33
Total, other adverse events	Phase I-GSK525762 60mg+FUL 500mg (CDK4/6+AI Failure < 12M)	12	12

1 to 10 of 24Source 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.

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