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NCT02684006 · OUTCOME

Ctrough 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
Nanograms per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre dose (0 hour) on day 15 and 29 of cycle 1 (each cycle= 6 weeks)

What was measured

Predose concentration during multiple dosing.

Analysis population: Axitinib PK concentration analysis set: 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 'Overall 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 + Axitinib312

Reported measurements

Cycle1 (day 15)

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib312
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib4.904172Not reportedNot reportedNot reported
Cycle1 (day 29)

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib302
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib6.272174Not reportedNot reportedNot reported
Complete source fields
classes
  1. 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)
  2. 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)
denoms
  1. counts
    1. group Id
      OG000
      value
      312
    units
    Participants
description
Predose concentration during multiple dosing.
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 set: 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 'Overall 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
Pre dose (0 hour) on day 15 and 29 of cycle 1 (each cycle= 6 weeks)
title
Ctrough of Axitinib
type
SECONDARY
unit Of Measure
Nanograms per milliliter

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

Preserved source evidence · Not medical advice