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NCT02431260 · OUTCOME

Overall Survival (OS)

An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies · Source last updated 2019-06-14

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline through end of study, up to 6 months for participants in Part 2

What was measured

OS is defined as the time from the date of randomization to the date of the participant's death.

Analysis population: As a result of early termination of the study, only participants in Part 2 of the study were evaluated; Treatment Group C was not evaluated due to early termination from the study.

Groups in this outcome

Part 2 / Treatment Group A: 20 MG BID INCB054329

Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.

Part 2 / Treatment Group C: 20 mg BID INCB054329

Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.

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 2 / Treatment Group A: 20 MG BID INCB05432910
Part 2 / Treatment Group C: 20 mg BID INCB0543290

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2 / Treatment Group A: 20 MG BID INCB0543297.09Not reported3.13NAThe upper CI limit of median PFS could not be estimated by the Brookmeyer and Crowley method because there were not enough events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper CI limit of median PFS could not be estimated by the Brookmeyer and Crowley method because there were not enough events.
        group Id
        OG000
        lower Limit
        3.13
        upper Limit
        NA
        value
        7.09
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      0
    units
    Participants
description
OS is defined as the time from the date of randomization to the date of the participant's death.
dispersion Type
95% Confidence Interval
groups
  1. description
    Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    OG000
    title
    Part 2 / Treatment Group A: 20 MG BID INCB054329
  2. description
    Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
    id
    OG001
    title
    Part 2 / Treatment Group C: 20 mg BID INCB054329
param Type
MEDIAN
population Description
As a result of early termination of the study, only participants in Part 2 of the study were evaluated; Treatment Group C was not evaluated due to early termination from the study.
reporting Status
POSTED
time Frame
Baseline through end of study, up to 6 months for participants in Part 2
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice