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NCT05949632 · OUTCOME

Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)

A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors · Source last updated 2026-06-04

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
up to 3 weeks

What was measured

Any adverse event that ws at least possibly related to study treatment and met protocol-specified criteria was classified as a DLT. For the purpose of dose finding, decisions on dose were based on DLTs observed during the first 21 days of treatment.

Analysis population: DLT-Evaluable Population: all participants in Part 1 who had a DLT during the 3-week DLT observation period or received at least 75% of the planned doses of both INCB099280 and axitinib at the assigned dose.

Groups in this outcome

INCB099280 400 mg BID Plus Axitinib 5 mg BID

Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.

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

Analysis denominator · Participants

GroupSource count
INCB099280 400 mg BID Plus Axitinib 5 mg BID5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
INCB099280 400 mg BID Plus Axitinib 5 mg BID1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Any adverse event that ws at least possibly related to study treatment and met protocol-specified criteria was classified as a DLT. For the purpose of dose finding, decisions on dose were based on DLTs observed during the first 21 days of treatment.
groups
  1. description
    Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
    id
    OG000
    title
    INCB099280 400 mg BID Plus Axitinib 5 mg BID
param Type
COUNT_OF_PARTICIPANTS
population Description
DLT-Evaluable Population: all participants in Part 1 who had a DLT during the 3-week DLT observation period or received at least 75% of the planned doses of both INCB099280 and axitinib at the assigned dose.
reporting Status
POSTED
time Frame
up to 3 weeks
title
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice