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NCT02082977 · OUTCOME

Part 1: Accumulation Ratio Following Administration of GSK2816126

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
NUMBER
Unit
Ratio of AUC
Interval / dispersion
90% Confidence Interval
Time frame
Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)

What was measured

Accumulation ratio was determined from the ratio of AUC (0-tau) on Cycle 1 Day 15/AUC (0-tau) on Cycle 1 Day 1 by dose cohort. Only those participants with data available at the specified data points were analyzed. To assess accumulation ratio for a dose level based on ANOVA method, it was required that at least 2 participants had derived PK parameter AUC(0- tau) on both Cycle 1 Day 1 and Cycle 1 Day 15. For dose 100mg, 200mg and 400mg, only 1 participant received treatment. For dose 50mg, 2 participants received treatment but there was one participant whose AUC(0- tau) on Cycle 1 Day 15 could not be derived due to discontinuation of treatment before Day 15. Hence, accumulation ratio could not be calculated for these 4 arms. Accumulation ratio of GSK2816126 was estimated by calculating the ratio of geometric least squares (GLS) means of the AUC between Day 15 and Day 1 for all dose levels and corresponding 90 percent (%) confidence interval (CI) for each ratio.

Analysis population: Pharmacokinetic Population. To assess accumulation ratio by ANOVA, it requires at least 2 participants to derive PK parameter AUC(0- tau) on both Cycle 1 Day 1 and Cycle 1 Day 15 which was not observed for dose 50mg, 100mg, 200mg and 400mg. Hence data could not be calculated for these 4 arms.

Groups in this outcome

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 800 mg Twice-weekly3
Part 1:GSK2816126 1200 mg Twice-weekly4
Part 1:GSK2816126 1800 mg Twice-weekly9
Part 1:GSK2816126 2400 mg Twice-weekly11
Part 1:GSK2816126 3000 mg Twice-weekly4

Reported measurements

Source class 1
Values in Ratio of AUC · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1:GSK2816126 800 mg Twice-weekly1.090Not reported0.8271.435Not reported
Part 1:GSK2816126 1200 mg Twice-weekly0.625Not reported0.2911.345Not reported
Part 1:GSK2816126 1800 mg Twice-weekly1.288Not reported1.1731.415Not reported
Part 1:GSK2816126 2400 mg Twice-weekly1.224Not reported1.0811.386Not reported
Part 1:GSK2816126 3000 mg Twice-weekly1.801Not reported0.8193.959Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.827
        upper Limit
        1.435
        value
        1.090
      2. group Id
        OG001
        lower Limit
        0.291
        upper Limit
        1.345
        value
        0.625
      3. group Id
        OG002
        lower Limit
        1.173
        upper Limit
        1.415
        value
        1.288
      4. group Id
        OG003
        lower Limit
        1.081
        upper Limit
        1.386
        value
        1.224
      5. group Id
        OG004
        lower Limit
        0.819
        upper Limit
        3.959
        value
        1.801
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      11
    5. group Id
      OG004
      value
      4
    units
    Participants
description
Accumulation ratio was determined from the ratio of AUC (0-tau) on Cycle 1 Day 15/AUC (0-tau) on Cycle 1 Day 1 by dose cohort. Only those participants with data available at the specified data points were analyzed. To assess accumulation ratio for a dose level based on ANOVA method, it was required that at least 2 participants had derived PK parameter AUC(0- tau) on both Cycle 1 Day 1 and Cycle 1 Day 15. For dose 100mg, 200mg and 400mg, only 1 participant received treatment. For dose 50mg, 2 participants received treatment but there was one participant whose AUC(0- tau) on Cycle 1 Day 15 could not be derived due to discontinuation of treatment before Day 15. Hence, accumulation ratio could not be calculated for these 4 arms. Accumulation ratio of GSK2816126 was estimated by calculating the ratio of geometric least squares (GLS) means of the AUC between Day 15 and Day 1 for all dose levels and corresponding 90 percent (%) confidence interval (CI) for each ratio.
dispersion Type
90% Confidence Interval
groups
  1. 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
    OG000
    title
    Part 1:GSK2816126 800 mg Twice-weekly
  2. 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
    OG001
    title
    Part 1:GSK2816126 1200 mg Twice-weekly
  3. 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
    OG002
    title
    Part 1:GSK2816126 1800 mg Twice-weekly
  4. 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
    OG003
    title
    Part 1:GSK2816126 2400 mg Twice-weekly
  5. 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
    OG004
    title
    Part 1:GSK2816126 3000 mg Twice-weekly
param Type
NUMBER
population Description
Pharmacokinetic Population. To assess accumulation ratio by ANOVA, it requires at least 2 participants to derive PK parameter AUC(0- tau) on both Cycle 1 Day 1 and Cycle 1 Day 15 which was not observed for dose 50mg, 100mg, 200mg and 400mg. Hence data could not be calculated for these 4 arms.
reporting Status
POSTED
time Frame
Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)
title
Part 1: Accumulation Ratio Following Administration of GSK2816126
type
SECONDARY
unit Of Measure
Ratio of AUC

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Preserved source evidence · Not medical advice