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NCT02903914 · OUTCOME

AUC0-8h of INCB001158 in Participants With Renal Impairment (Part 1C) and Normal Renal Function (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
hours x ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose

What was measured

AUC0-8h was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to 8 hours post-dose.

Analysis population: PK Population. Only participants with available data were analyzed. Analysis was conducted to compare INCB001158 50 mg + pembrolizumab in participants with renal impairment with INCB001158 50 mg or 75 mg in participants with normal renal function. It was pre-specified to collect data for only the Part 1A INCB001158 50 mg, Part 1A: INCB001158 75 mg, and Part 1C: INCB001158 50 mg + Pembrolizumab arms. Participants in the INCB001158 100 mg and 150 mg arms did not contribute to the analysis.

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.

Part 1C: INCB001158 50 mg + Pembrolizumab

INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.

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 mg8
Part 1A: INCB001158 75 mg7
Part 1A: INCB001158 100 mg0
Part 1A: INCB001158 150 mg0
Part 1C: INCB001158 50 mg + Pembrolizumab5

Reported measurements

Source class 1
Values in hours x ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1A: INCB001158 50 mg44800.29Not reportedNot reportedNot reported
Part 1A: INCB001158 75 mg78900.26Not reportedNot reportedNot reported
Part 1C: INCB001158 50 mg + Pembrolizumab52100.29Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.29
        value
        4480
      2. group Id
        OG001
        spread
        0.26
        value
        7890
      3. group Id
        OG004
        spread
        0.29
        value
        5210
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      5
    units
    Participants
description
AUC0-8h was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to 8 hours post-dose.
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
  5. description
    INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.
    id
    OG004
    title
    Part 1C: INCB001158 50 mg + Pembrolizumab
param Type
GEOMETRIC_MEAN
population Description
PK Population. Only participants with available data were analyzed. Analysis was conducted to compare INCB001158 50 mg + pembrolizumab in participants with renal impairment with INCB001158 50 mg or 75 mg in participants with normal renal function. It was pre-specified to collect data for only the Part 1A INCB001158 50 mg, Part 1A: INCB001158 75 mg, and Part 1C: INCB001158 50 mg + Pembrolizumab arms. Participants in the INCB001158 100 mg and 150 mg arms did not contribute to the analysis.
reporting Status
POSTED
time Frame
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose
title
AUC0-8h of INCB001158 in Participants With Renal Impairment (Part 1C) and Normal Renal Function (Part 1A)
type
SECONDARY
unit Of Measure
hours x ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice