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NCT02082977 · OUTCOME

Part 1: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 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. 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:GSK2816126 50 mg Twice-weekly

Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

Part 1:GSK2816126 100 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

Part 1:GSK2816126 200 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

Part 1:GSK2816126 400 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

Part 1:GSK2816126 800 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

Part 1:GSK2816126 1200 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

Part 1:GSK2816126 1800 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

Part 1:GSK2816126 2400 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

Part 1:GSK2816126 3000 mg Twice-weekly

Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).

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:GSK2816126 50 mg Twice-weekly0
Part 1:GSK2816126 100 mg Twice-weekly0
Part 1:GSK2816126 200 mg Twice-weekly0
Part 1:GSK2816126 400 mg Twice-weekly0
Part 1:GSK2816126 800 mg Twice-weekly0
Part 1:GSK2816126 1200 mg Twice-weekly0
Part 1:GSK2816126 1800 mg Twice-weekly0
Part 1:GSK2816126 2400 mg Twice-weekly0
Part 1:GSK2816126 3000 mg Twice-weekly0

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
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      0
    units
    Participants
description
The amount of GSK2816126 excreted in urine after dosing at steady state was 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. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.
groups
  1. description
    Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    OG000
    title
    Part 1:GSK2816126 50 mg Twice-weekly
  2. description
    Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    OG001
    title
    Part 1:GSK2816126 100 mg Twice-weekly
  3. description
    Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    OG002
    title
    Part 1:GSK2816126 200 mg Twice-weekly
  4. description
    Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    OG003
    title
    Part 1:GSK2816126 400 mg Twice-weekly
  5. description
    Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    OG004
    title
    Part 1:GSK2816126 800 mg Twice-weekly
  6. description
    Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    OG005
    title
    Part 1:GSK2816126 1200 mg Twice-weekly
  7. description
    Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    OG006
    title
    Part 1:GSK2816126 1800 mg Twice-weekly
  8. description
    Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    OG007
    title
    Part 1:GSK2816126 2400 mg Twice-weekly
  9. description
    Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    OG008
    title
    Part 1:GSK2816126 3000 mg Twice-weekly
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 in Urine After Dosing at Steady State
type
SECONDARY

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

Preserved source evidence · Not medical advice