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NCT02903914 · OUTCOME

Vz/F of INCB001158 Following Single 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
Liters
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose

What was measured

Vz/F was defined as the apparent volume of distribution 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 mg8
Part 1A: INCB001158 75 mg7
Part 1A: INCB001158 100 mg8
Part 1A: INCB001158 150 mg7

Reported measurements

Source class 1
Values in Liters · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1A: INCB001158 50 mg460000.29Not reportedNot reportedNot reported
Part 1A: INCB001158 75 mg401000.22Not reportedNot reportedNot reported
Part 1A: INCB001158 100 mg513000.32Not reportedNot reportedNot reported
Part 1A: INCB001158 150 mg501000.30Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.29
        value
        46000
      2. group Id
        OG001
        spread
        0.22
        value
        40100
      3. group Id
        OG002
        spread
        0.32
        value
        51300
      4. group Id
        OG003
        spread
        0.30
        value
        50100
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      7
    units
    Participants
description
Vz/F was defined as the apparent volume of distribution 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 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
title
Vz/F of INCB001158 Following Single Escalating Doses for Part 1A
type
SECONDARY
unit Of Measure
Liters

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

Preserved source evidence · Not medical advice