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NCT02431260 · OUTCOME

Objective Response Rate (ORR)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline through end of study, up to 6 months

What was measured

Defined as the percentage of subjects having complete response (CR) or partial response (PR). The best overall response was defined as the best response recorded before and including the first event of Progressive disease (PD).

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

Complete response (CR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 / Treatment Group A: 20 MG BID INCB0543290Not reportedNot reportedNot reportedNot reported

Partial response (PR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 / Treatment Group A: 20 MG BID INCB0543290Not reportedNot reportedNot reportedNot reported

Stable disease (SD) >= 6 months

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 / Treatment Group A: 20 MG BID INCB0543290Not reportedNot reportedNot reportedNot reported

Stable disease (SD) < 6 months

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 / Treatment Group A: 20 MG BID INCB0543294Not reportedNot reportedNot reportedNot reported

Progressive disease (PD)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 / Treatment Group A: 20 MG BID INCB0543295Not reportedNot reportedNot reportedNot reported

Not evaluable (NE)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 / Treatment Group A: 20 MG BID INCB0543291Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      title
      Complete response (CR)
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Partial response (PR)
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Stable disease (SD) >= 6 months
    4. measurements
      1. group Id
        OG000
        value
        4
      title
      Stable disease (SD) < 6 months
    5. measurements
      1. group Id
        OG000
        value
        5
      title
      Progressive disease (PD)
    6. measurements
      1. group Id
        OG000
        value
        1
      title
      Not evaluable (NE)
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Defined as the percentage of subjects having complete response (CR) or partial response (PR). The best overall response was defined as the best response recorded before and including the first event of Progressive disease (PD).
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
COUNT_OF_PARTICIPANTS
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
title
Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice