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NCT02860286 · OUTCOME

Part 1: Pharmacokinetics Profile of Tazemetostat and Its Metabolite (Plasma): AUC(0-t)

Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma · Source last updated 2021-04-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
h*ng/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 15: pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and12 post-dose.

What was measured

To assess the pharmacokinetic (PK) and safety profile of single (Cycle 1 day 1) and repeated doses (Cycle 1 day 2 onwards) of 800 mg tazemetostat administered as 400 mg tablets in subjects with relapsed or refractory malignant mesothelioma regardless of BRCA1 associated protein 1 (BAP1) status

Groups in this outcome

Part 1 (Pharmacokinetics)

Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status were to be treated and PK blood samples collected after a single tazemetostat 800 mg dose on Cycle 1 Day 1 and after repeated twice daily doses of tazemetostat 800 mg on Cycle 1 Day 15. Subjects were to receive a single oral 800 mg tazemetostat dose on Cycle 1 Day 1. Starting on Cycle 1 Day 2, tazemetostat was orally administered at a dose of 800 mg twice daily.

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 (Pharmacokinetics)13

Reported measurements

Source class 1
Values in h*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1 (Pharmacokinetics)36501640Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1640
        value
        3650
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
To assess the pharmacokinetic (PK) and safety profile of single (Cycle 1 day 1) and repeated doses (Cycle 1 day 2 onwards) of 800 mg tazemetostat administered as 400 mg tablets in subjects with relapsed or refractory malignant mesothelioma regardless of BRCA1 associated protein 1 (BAP1) status
dispersion Type
Standard Deviation
groups
  1. description
    Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status were to be treated and PK blood samples collected after a single tazemetostat 800 mg dose on Cycle 1 Day 1 and after repeated twice daily doses of tazemetostat 800 mg on Cycle 1 Day 15. Subjects were to receive a single oral 800 mg tazemetostat dose on Cycle 1 Day 1. Starting on Cycle 1 Day 2, tazemetostat was orally administered at a dose of 800 mg twice daily.
    id
    OG000
    title
    Part 1 (Pharmacokinetics)
param Type
MEAN
reporting Status
POSTED
time Frame
Cycle 1 Day 15: pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and12 post-dose.
title
Part 1: Pharmacokinetics Profile of Tazemetostat and Its Metabolite (Plasma): AUC(0-t)
type
PRIMARY
unit Of Measure
h*ng/mL

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

Preserved source evidence · Not medical advice