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NCT03614728 · OUTCOME

Part 2: Time Invariance Following Administration of 5-Azacitidine

Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) · Source last updated 2023-02-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Days 1 and 8:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute) post-dose

What was measured

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

Analysis population: PK Population. Data was not collected as no participants were enrolled in Part 2.

Groups in this outcome

Part 2-Dose Escalation: GSK3326595+5-Azacitidine

Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.

Part 2-Dose Expansion: GSK3326595+5-Azacitidine

Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 2-Dose Escalation: GSK3326595+5-Azacitidine0
Part 2-Dose Expansion: GSK3326595+5-Azacitidine0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.
groups
  1. description
    Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
    id
    OG000
    title
    Part 2-Dose Escalation: GSK3326595+5-Azacitidine
  2. description
    Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.
    id
    OG001
    title
    Part 2-Dose Expansion: GSK3326595+5-Azacitidine
population Description
PK Population. Data was not collected as no participants were enrolled in Part 2.
reporting Status
POSTED
time Frame
Days 1 and 8:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute) post-dose
title
Part 2: Time Invariance Following Administration of 5-Azacitidine
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice