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NCT02082977 · OUTCOME

Part 1: Concentration of GSK2816126 and Its Metabolites in Urine

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

Urine samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.

Analysis population: Pharmacokinetic Population. Samples were not collected due to early study termination.

Groups in this outcome

Part 1: Participants With GCB-DLBCL

At maximum tolerated or recommended phase II dose, participants with GCB-DLBCL were enrolled in Part 1 expansion cohorts and received GSK2816126 twice-weekly, as intravenous solution.

Part 1: Participants With Solid Tumors

At maximum tolerated or recommended phase II dose, participants with solid tumors were enrolled in Part 1 expansion cohorts and received GSK2816126 twice-weekly, as intravenous solution.

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 1: Participants With GCB-DLBCL0
Part 1: Participants With Solid Tumors0

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
Urine samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.
groups
  1. description
    At maximum tolerated or recommended phase II dose, participants with GCB-DLBCL were enrolled in Part 1 expansion cohorts and received GSK2816126 twice-weekly, as intravenous solution.
    id
    OG000
    title
    Part 1: Participants With GCB-DLBCL
  2. description
    At maximum tolerated or recommended phase II dose, participants with solid tumors were enrolled in Part 1 expansion cohorts and received GSK2816126 twice-weekly, as intravenous solution.
    id
    OG001
    title
    Part 1: Participants With Solid Tumors
population Description
Pharmacokinetic Population. Samples were not collected due to early study termination.
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 1: Concentration of GSK2816126 and Its Metabolites in Urine
type
SECONDARY

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

Preserved source evidence · Not medical advice