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NCT02860286 · OUTCOME

Part 1: Pharmacokinetics Profile of Tazemetostat and Its Metabolite (Plasma): Cmax

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
Ng/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 15: pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 12 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)

Assessment of 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.

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 Ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1 (Pharmacokinetics)933440Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        440
        value
        933
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
    Assessment of 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.
    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, and 12 post-dose
title
Part 1: Pharmacokinetics Profile of Tazemetostat and Its Metabolite (Plasma): Cmax
type
PRIMARY
unit Of Measure
Ng/mL

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

Preserved source evidence · Not medical advice