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NCT02082977 · OUTCOME

Part 1: Exposure Producing 50 Percent of the Maximum Effect (EC50) of GSK2816126 With Respect to Exposure Markers

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
Up to 3.2 years

What was measured

The pharmacokinetic/pharmacodynamic relationship between GSK2816126 exposure markers (dose, concentration, Cmax or AUC) was planned to be characterized by linear and/or non-linear mixed effect models. This analysis was planned to be based on Pharmacodynamic Population which consists of participants in the All Subjects population for whom a pharmacodynamics/biomarkers sample was obtained and analyzed. This analysis was planned but not performed as the pharmacodynamic response was not observed and therefore a relationship between pharmacokinetic and pharmacodynamic parameters could not be determined.

Analysis population: Pharmacodynamic Population. Analysis was not performed as pharmacodynamic response was not observed.

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 pharmacokinetic/pharmacodynamic relationship between GSK2816126 exposure markers (dose, concentration, Cmax or AUC) was planned to be characterized by linear and/or non-linear mixed effect models. This analysis was planned to be based on Pharmacodynamic Population which consists of participants in the All Subjects population for whom a pharmacodynamics/biomarkers sample was obtained and analyzed. This analysis was planned but not performed as the pharmacodynamic response was not observed and therefore a relationship between pharmacokinetic and pharmacodynamic parameters could not be determined.
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
Pharmacodynamic Population. Analysis was not performed as pharmacodynamic response was not observed.
reporting Status
POSTED
time Frame
Up to 3.2 years
title
Part 1: Exposure Producing 50 Percent of the Maximum Effect (EC50) of GSK2816126 With Respect to Exposure Markers
type
SECONDARY

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Preserved source evidence · Not medical advice