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NCT03349333 · OUTCOME

Maximum Observed Plasma Concentration [Cmax] for S-pralatrexate

A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL · Source last updated 2019-10-01

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）

What was measured

The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.

Analysis population: PK population

Groups in this outcome

Pralatrexate

Vitamin B12 and folic acid will be taken concurrently with pralatrexate pralatrexate: Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle. Vitamin B12 and folic acid: The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Pralatrexate15

Reported measurements

Pralatrexate-S in Cycle 1 day 1（30mg/m2）

Analysis denominator · Participants

GroupSource count
Pralatrexate15
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Pralatrexate3727.8582118.25Not reportedNot reportedNot reported
Pralatrexate-S in Cycle 1 week 6（20mg/m2）

Analysis denominator · Participants

GroupSource count
Pralatrexate3
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Pralatrexate2325.510524.22Not reportedNot reportedNot reported
Pralatrexate-S in Cycle 1 week 6（30mg/m2）

Analysis denominator · Participants

GroupSource count
Pralatrexate9
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Pralatrexate3439.9695697.55Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        118.25
        value
        3727.8582
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    Pralatrexate-S in Cycle 1 day 1（30mg/m2）
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.22
        value
        2325.5105
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Pralatrexate-S in Cycle 1 week 6（20mg/m2）
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        697.55
        value
        3439.9695
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Pralatrexate-S in Cycle 1 week 6（30mg/m2）
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Vitamin B12 and folic acid will be taken concurrently with pralatrexate pralatrexate: Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle. Vitamin B12 and folic acid: The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator.
    id
    OG000
    title
    Pralatrexate
param Type
GEOMETRIC_MEAN
population Description
PK population
reporting Status
POSTED
time Frame
Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）
title
Maximum Observed Plasma Concentration [Cmax] for S-pralatrexate
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice