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NCT06056310 · OUTCOME

Absolute Change From Baseline in eGFR

Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX) · Source last updated 2025-09-29

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

Measure
MEAN
Unit
mL/min/1.73 m^2
Interval / dispersion
Standard Deviation
Time frame
Baseline, C1D4, C1D11, C1D18, C2D1, C2D4, C2D11, C2D18, C3D1, C3D4, C4D1, C5D1, C6D1 and End of treatment (Day 134) (each cycle is of 3 weeks)

What was measured

eGFR creatinine was evaluated using CKD-EPI formula. Absolute change from baseline in eGFR was presented.

Analysis population: SAS included all participants who were administered any dose of any study intervention. Here "number analyzed" signifies participants who were evaluable at specified timepoints.

Groups in this outcome

Sequence 1

Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

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

Analysis denominator · Participants

GroupSource count
Sequence 118

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Sequence 118
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 189.690813.35296Not reportedNot reportedNot reported
C1D4

Analysis denominator · Participants

GroupSource count
Sequence 117
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 1-7.190810.69578Not reportedNot reportedNot reported
C1D11

Analysis denominator · Participants

GroupSource count
Sequence 116
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 1-8.253217.46117Not reportedNot reportedNot reported
C1D18

Analysis denominator · Participants

GroupSource count
Sequence 115
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 1-5.86966.03911Not reportedNot reportedNot reported
C2D1

Analysis denominator · Participants

GroupSource count
Sequence 116
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 12.305210.00664Not reportedNot reportedNot reported
C2D4

Analysis denominator · Participants

GroupSource count
Sequence 113
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 1-6.363213.50060Not reportedNot reportedNot reported
C2D11

Analysis denominator · Participants

GroupSource count
Sequence 115
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 1-9.302116.44543Not reportedNot reportedNot reported
C2D18

Analysis denominator · Participants

GroupSource count
Sequence 113
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 1-4.738812.75881Not reportedNot reportedNot reported
C3D1

Analysis denominator · Participants

GroupSource count
Sequence 116
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 1-2.910314.80991Not reportedNot reportedNot reported
C3D4

Analysis denominator · Participants

GroupSource count
Sequence 113
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 1-6.705014.90582Not reportedNot reportedNot reported
C4D1

Analysis denominator · Participants

GroupSource count
Sequence 17
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 1-3.345125.03351Not reportedNot reportedNot reported
C5D1

Analysis denominator · Participants

GroupSource count
Sequence 15
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 1-5.331212.52264Not reportedNot reportedNot reported
C6D1

Analysis denominator · Participants

GroupSource count
Sequence 12
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 1-26.50007.77817Not reportedNot reportedNot reported
End of treatment

Analysis denominator · Participants

GroupSource count
Sequence 117
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 1-2.478916.82505Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.35296
        value
        89.6908
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.69578
        value
        -7.1908
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    C1D4
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.46117
        value
        -8.2532
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    C1D11
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.03911
        value
        -5.8696
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    C1D18
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.00664
        value
        2.3052
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    C2D1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.50060
        value
        -6.3632
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    C2D4
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.44543
        value
        -9.3021
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    C2D11
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.75881
        value
        -4.7388
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    C2D18
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.80991
        value
        -2.9103
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    C3D1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.90582
        value
        -6.7050
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    C3D4
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.03351
        value
        -3.3451
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    C4D1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.52264
        value
        -5.3312
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    C5D1
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
eGFR creatinine was evaluated using CKD-EPI formula. Absolute change from baseline in eGFR was presented.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
    id
    OG000
    title
    Sequence 1
param Type
MEAN
population Description
SAS included all participants who were administered any dose of any study intervention. Here "number analyzed" signifies participants who were evaluable at specified timepoints.
reporting Status
POSTED
time Frame
Baseline, C1D4, C1D11, C1D18, C2D1, C2D4, C2D11, C2D18, C3D1, C3D4, C4D1, C5D1, C6D1 and End of treatment (Day 134) (each cycle is of 3 weeks)
title
Absolute Change From Baseline in eGFR
type
SECONDARY
unit Of Measure
mL/min/1.73 m^2

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Preserved source evidence · Not medical advice