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NCT02718417 · OUTCOME

Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once a Week [QW] Regimen)

Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100) · Source last updated 2020-07-14

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
Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2

What was measured

Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL.

Analysis population: Paclitaxel PK parameter analysis set: all participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on QW regimen and had data available for this outcome measure.

Groups in this outcome

PK: Chemotherapy Followed by Avelumab

In chemotherapy phase, participants received paclitaxel once every three weeks (Q3W) (or once weekly \[QW\] on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab once every 2 weeks (Q2W) on Days 1, 15 and 29 of each 42 day cycle.

PK: Chemotherapy + Avelumab Followed by Avelumab

In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).

PK: Chemotherapy Followed by Observation

In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.

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

Analysis denominator · Participants

GroupSource count
PK: Chemotherapy Followed by Avelumab6
PK: Chemotherapy + Avelumab Followed by Avelumab4
PK: Chemotherapy Followed by Observation9

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
PK: Chemotherapy Followed by Avelumab288044Not reportedNot reportedNot reported
PK: Chemotherapy + Avelumab Followed by Avelumab267822Not reportedNot reportedNot reported
PK: Chemotherapy Followed by Observation264935Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        44
        value
        2880
      2. group Id
        OG001
        spread
        22
        value
        2678
      3. group Id
        OG002
        spread
        35
        value
        2649
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      9
    units
    Participants
description
Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    In chemotherapy phase, participants received paclitaxel once every three weeks (Q3W) (or once weekly \[QW\] on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab once every 2 weeks (Q2W) on Days 1, 15 and 29 of each 42 day cycle.
    id
    OG000
    title
    PK: Chemotherapy Followed by Avelumab
  2. description
    In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
    id
    OG001
    title
    PK: Chemotherapy + Avelumab Followed by Avelumab
  3. description
    In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
    id
    OG002
    title
    PK: Chemotherapy Followed by Observation
param Type
GEOMETRIC_MEAN
population Description
Paclitaxel PK parameter analysis set: all participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on QW regimen and had data available for this outcome measure.
reporting Status
POSTED
time Frame
Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2
title
Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once a Week [QW] Regimen)
type
SECONDARY
unit Of Measure
ng/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice