Trial · NCT02964507
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| 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. |
| 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 | Blood samples were collected at indicated time points for PK analysis of GSK3529246. GSK3529246 is an active metabolite of GSK525762. |
| Secondary | Phase I: Plasma Concentration of Fulvestrant | Day 1: Pre-dose on Weeks 1, 3, 5, 9, 17, 25 | Blood samples were collected at indicated time points for PK analysis of Fulvestrant. |
| Secondary | Phase II: Overall Survival (OS) | Up to 3 year and 8 months | OS is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. |
| Secondary | Phase II: Overall Response Rate (ORR) | Up to 3 year and 8 months | ORR is defined as the percentage of participants in the population who demonstrate a BOR of confirmed CR or PR, as assessed by the investigator per RECIST v1.1 criteria. |
| Secondary | Phase II: 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 CR, confirmed PR, or SD lasting \>=6 months, as assessed by the investigator per RECIST v1.1 criteria. |
| 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 | Blood samples were planned to be collected for PK analysis of GSK525762 and GSK3529246. GSK3529246 is metabolite of GSK525762. |
| Secondary | Phase II: Plasma Concentration of Fulvestrant | Day 1: Pre-dose on Weeks 1, 3, 5, 9, 17, 25 | Blood samples were planned to be collected for PK analysis of fulvestrant. |
| Other | 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 | 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. Number of participants with non-serious AEs and SAEs collected from start of the treatment until end of the study were reported. |
| Other | Phase I: Number of Participants With Dose Reductions and Dose Interruption/Delays Until End of the Study | Up to 4 year and 4 months | Number of participants with dose reductions and dose interruption or delay due to any reason is presented. Number of participants with dose reductions and dose interruption or delay due to any reason from start of the treatment until end of the study were reported. |
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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