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NCT02903914 · OUTCOME

Tmax 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
MEDIAN
Unit
hours
Interval / dispersion
Full Range
Time frame
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 (Part 1A only) hours post-dose.

What was measured

tmax was defined as the time of the maximum observed concentration of INCB001158.

Analysis population: PK Population. 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 + Pembrolizumab6

Reported measurements

Source class 1
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1A: INCB001158 50 mg3.9Not reported2.04.1Not reported
Part 1A: INCB001158 75 mg2.0Not reported2.06.2Not reported
Part 1C: INCB001158 50 mg + Pembrolizumab5.9Not reported3.97.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        4.1
        value
        3.9
      2. group Id
        OG001
        lower Limit
        2.0
        upper Limit
        6.2
        value
        2.0
      3. group Id
        OG004
        lower Limit
        3.9
        upper Limit
        7.9
        value
        5.9
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
      6
    units
    Participants
description
tmax was defined as the time of the maximum observed concentration of INCB001158.
dispersion Type
Full Range
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
MEDIAN
population Description
PK Population. 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, 8, 12, and 24 (Part 1A only) hours post-dose.
title
Tmax of INCB001158 in Participants With Renal Impairment (Part 1C) and Normal Renal Function (Part 1A)
type
SECONDARY
unit Of Measure
hours

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Preserved source evidence · Not medical advice