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NCT02903914 · OUTCOME

Cmax of INCB001158 Following Multiple Escalating Doses for Part 1A

Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors · Source last updated 2025-08-05

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 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose

What was measured

Cmax was defined as the maximum observed concentration of INCB001158.

Analysis population: PK Population

Groups in this outcome

Part 1A: INCB001158 50 mg

INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.

Part 1A: INCB001158 75 mg

INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.

Part 1A: INCB001158 100 mg

INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.

Part 1A: INCB001158 150 mg

INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.

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

Analysis denominator · Participants

GroupSource count
Part 1A: INCB001158 50 mg6
Part 1A: INCB001158 75 mg7
Part 1A: INCB001158 100 mg7
Part 1A: INCB001158 150 mg6

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1A: INCB001158 50 mg9870.28Not reportedNot reportedNot reported
Part 1A: INCB001158 75 mg18800.28Not reportedNot reportedNot reported
Part 1A: INCB001158 100 mg19900.26Not reportedNot reportedNot reported
Part 1A: INCB001158 150 mg33700.30Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Type
    OTHER
    p Value
    0.0745
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
    statistical Method
    ANOVA
  2. ci Lower Limit
    0.947
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.341
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    OTHER
    param Type
    pairwise GMR
    param Value
    1.127
  3. ci Lower Limit
    0.833
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.180
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    OTHER
    param Type
    pairwise GMR
    param Value
    0.991
  4. ci Lower Limit
    1.064
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.486
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    OTHER
    param Type
    pairwise GMR
    param Value
    1.258
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Type
    OTHER
    p Value
    0.0745
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
    statistical Method
    ANOVA
  2. ci Lower Limit
    0.947
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.341
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    OTHER
    param Type
    pairwise GMR
    param Value
    1.127
  3. ci Lower Limit
    0.833
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.180
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    OTHER
    param Type
    pairwise GMR
    param Value
    0.991
  4. ci Lower Limit
    1.064
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.486
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    OTHER
    param Type
    pairwise GMR
    param Value
    1.258
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.28
        value
        987
      2. group Id
        OG001
        spread
        0.28
        value
        1880
      3. group Id
        OG002
        spread
        0.26
        value
        1990
      4. group Id
        OG003
        spread
        0.30
        value
        3370
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      6
    units
    Participants
description
Cmax was defined as the maximum observed concentration of INCB001158.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
    id
    OG000
    title
    Part 1A: INCB001158 50 mg
  2. description
    INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
    id
    OG001
    title
    Part 1A: INCB001158 75 mg
  3. description
    INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
    id
    OG002
    title
    Part 1A: INCB001158 100 mg
  4. description
    INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
    id
    OG003
    title
    Part 1A: INCB001158 150 mg
param Type
GEOMETRIC_MEAN
population Description
PK Population
reporting Status
POSTED
time Frame
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
title
Cmax of INCB001158 Following Multiple Escalating Doses for Part 1A
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice