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NCT02684006 · OUTCOME

Maximum Plasma Concentration (Cmax) of Axitinib

A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) · Source last updated 2025-07-30

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

Measure
GEOMETRIC_MEAN
Unit
Nanogram per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
2 hours post-dose on Day 1, pre-dose and 2 hours post dose on Days 15 and 29 of Cycle 1

Analysis population: Axitinib PK concentration analysis: all participants who received at least one dose of study drug and have at least one post-dose concentration above lower limit of quantitation (LLQ) for axitinib. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows. This outcome measure was not planned to be analyzed in ''Sunitinib'' reporting group.

Groups in this outcome

Avelumab + Axitinib

Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.

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

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib316

Reported measurements

Cycle1 (day 1); Post Dose

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib316
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib17.93182Not reportedNot reportedNot reported
Cycle1 (day 15); Pre-Dose

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib312
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib4.904172Not reportedNot reportedNot reported
Cycle1 (day 15); Post Dose

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib286
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib18.45157Not reportedNot reportedNot reported
Cycle1 (day 29); Pre-Dose

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib302
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib6.272174Not reportedNot reportedNot reported
Cycle1 (day 29); Post Dose

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib272
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib17.19174Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        182
        value
        17.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        316
      units
      Participants
    title
    Cycle1 (day 1); Post Dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        172
        value
        4.904
    denoms
    1. counts
      1. group Id
        OG000
        value
        312
      units
      Participants
    title
    Cycle1 (day 15); Pre-Dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        157
        value
        18.45
    denoms
    1. counts
      1. group Id
        OG000
        value
        286
      units
      Participants
    title
    Cycle1 (day 15); Post Dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        174
        value
        6.272
    denoms
    1. counts
      1. group Id
        OG000
        value
        302
      units
      Participants
    title
    Cycle1 (day 29); Pre-Dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        174
        value
        17.19
    denoms
    1. counts
      1. group Id
        OG000
        value
        272
      units
      Participants
    title
    Cycle1 (day 29); Post Dose
denoms
  1. counts
    1. group Id
      OG000
      value
      316
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.
    id
    OG000
    title
    Avelumab + Axitinib
param Type
GEOMETRIC_MEAN
population Description
Axitinib PK concentration analysis: all participants who received at least one dose of study drug and have at least one post-dose concentration above lower limit of quantitation (LLQ) for axitinib. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows. This outcome measure was not planned to be analyzed in ''Sunitinib'' reporting group.
reporting Status
POSTED
time Frame
2 hours post-dose on Day 1, pre-dose and 2 hours post dose on Days 15 and 29 of Cycle 1
title
Maximum Plasma Concentration (Cmax) of Axitinib
type
SECONDARY
unit Of Measure
Nanogram per milliliter

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

Preserved source evidence · Not medical advice