Trial · NCT02964507
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| 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 |
| SECONDARY | Phase I: Plasma Concentration of GSK3529246 | 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. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles). | Nanograms per milliliter | MEAN |
| SECONDARY | Phase I: Plasma Concentration of Fulvestrant | Day 1: Pre-dose on Weeks 1, 3, 5, 9, 17, 25 | PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles). | Nanograms per milliliter | MEAN |
| SECONDARY | Phase II: Overall Survival (OS) | 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 II: Overall Response Rate (ORR) | 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 II: Disease Control Rate (DCR) | 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 II: Plasma Concentration of GSK525762 and GSK3529246 | 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. Phase II of study was not initiated hence data was not collected and analyzed. | ||
| SECONDARY | Phase II: Plasma Concentration of Fulvestrant | Day 1: Pre-dose on Weeks 1, 3, 5, 9, 17, 25 | PK Population. Phase II of study was not initiated hence data was not collected and analyzed. | ||
| OTHER_PRE_SPECIFIED | Phase I: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) Until End of the Study | Up to 4 year and 4 months | All Treated Population consisted of participants who received at least one dose of study treatment (GSK525762 or fulvestrant). | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Phase I: Number of Participants With Dose Reductions and Dose Interruption/Delays Until End of the Study | Up to 4 year and 4 months | All Treated Population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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