Trial · NCT03614728
Outcomes58
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 58
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Percentage of Participants With Clinical Benefit Rate (CBR) | Up to 30.8 months | All Treated Population consisted of all participants who received at least one dose of GSK3326595 as monotherapy or at least one dose of both combination drugs as combination treatment. | Percentage of Participants | NUMBER |
| PRIMARY | Part 2: Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment Emergent Adverse Events (STEAEs) | Up to 3 years and 2 months | All Treated Population. Data was not collected as no participants were enrolled in Part 2. | ||
| PRIMARY | Part 2: Number of Participants With AEs by Severity | Up to 3 years and 2 months | All Treated Population. Data was not collected as no participants were enrolled in Part 2. | ||
| PRIMARY | Part 2: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 28 days | DLT Evaluable Population is defined as participants who received at least 75 percent (%) of the planned doses of GSK3326595 and all seven planned doses of 5-Azacitidine (Part 2) within the 28-day DLT observation period or those who have had a DLT. Data was not collected as no participants were enrolled in Part 2. | ||
| PRIMARY | Part 2: Number of Participants With AEs Leading to Dose Interruptions, Dose Reductions and Treatment Discontinuation Due to AEs | Up to 3 years and 2 months | All Treated Population. Data was not collected as no participants were enrolled in Part 2. | ||
| SECONDARY | Part 1: Number of Participants With Common Non-STEAEs and STEAEs | Up to 30.8 months | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1: Number of Participants With AEs by Severity | Up to 30.8 months | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1: Number of Participants With DLTs | Up to 28 days | DLT Evaluable Population. Only those participants with data available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1: Overall Response Rate | Up to 30.8 months | All Treated Population. | Percentage of Participants | NUMBER |
| SECONDARY | Part 1: Progression Free Survival | Up to 30.8 months | All Treated Population. | Months | MEDIAN |
| SECONDARY | Part 1: Overall Survival | Up to 30.8 months | All Treated Population. | Months | MEDIAN |
| SECONDARY | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 Following Administration of Single Dose | Day 1:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour) post-dose | Pharmacokinetic (PK) Population consisted of all participants from the All Treated Population for whom a PK sample was obtained and analyzed. | Nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1: Cmax of GSK3326595 Following Administration of Repeat Dose | Day 15:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour) post-dose | PK Population. Only those participants with data available at the indicated time points were analyzed. | Nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1: Time of Maximum Concentration Observed (Tmax) of GSK3326595 Following Administration of Single Dose | Day 1:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour) post-dose | PK Population | Hours | MEDIAN |
| SECONDARY | Part 1: Tmax of GSK3326595 Following Administration of Repeat Dose | Day 15:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour) post-dose | PK Population. Only those participants with data available at the indicated time points were analyzed. | Hours | MEDIAN |
| SECONDARY | Part 1: Apparent Terminal Phase Half-life (t1/2) of GSK3326595 Following Administration of Single Dose | Day 1:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour) post-dose | PK Population. Only those participants with data available at the indicated time points were analyzed. | Hours | GEOMETRIC_MEAN |
| SECONDARY | Part 1: t1/2 of GSK3326595 Following Administration of Repeat Dose | Day 15:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour) post-dose | PK Population. Only those participants with data available at the specified time points were analyzed. | Hours | GEOMETRIC_MEAN |
| SECONDARY | Part 1: Area Under Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within Participant Across All Treatments (AUC[0-t]) of GSK3326595 Following Administration of Single Dose | Day 1:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour) post-dose | PK Population | Hours*nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1: AUC(0-t) of GSK3326595 Following Administration of Repeat Dose | Day 15:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour) post-dose | PK Population. Only those participants with data available at the specified time points were analyzed. | Hours*nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1: AUC From 0 Hours to the Time of Next Dosing (AUC[0-tau]) of GSK3326595 | Day 15:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour) post-dose | PK Population. Only those participants with data available at the specified time points were analyzed. | Hours*nanogram per milliliter | GEOMETRIC_MEAN |
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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