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NCT02082977 · OUTCOME

Part 2:Concentration of GSK2816126 in Urine After Dosing at Steady State

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma · Source last updated 2020-02-25

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
Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15

What was measured

The amount of GSK2816126 excreted in urine after dosing at steady state was planned to be determined. The concentration of GSK2816126 in urine was planned to be measured with an investigational bio-analytical method and extrapolated to total amount excreted in urine over time using urine volume. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Analysis population: Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.

Groups in this outcome

Part 2: All Participants

Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .

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: All Participants0

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
    units
    Participants
description
The amount of GSK2816126 excreted in urine after dosing at steady state was planned to be determined. The concentration of GSK2816126 in urine was planned to be measured with an investigational bio-analytical method and extrapolated to total amount excreted in urine over time using urine volume. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
groups
  1. description
    Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
    id
    OG000
    title
    Part 2: All Participants
population Description
Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
reporting Status
POSTED
time Frame
Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15
title
Part 2:Concentration of GSK2816126 in Urine After Dosing at Steady State
type
SECONDARY

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

Preserved source evidence · Not medical advice