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NCT02587598 · OUTCOME

Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With Azacitidine in Subjects With Newly Diagnosed AML Who Are 65 Years or Older and Unfit for Intensive Chemotherapy Based on ORR

Study of INCB053914 in Subjects With Advanced Malignancies · Source last updated 2021-12-08

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Approximately 6 months

What was measured

The primary efficacy endpoint of ORR in patients with AML who received INCB053914 plus azacitidine in Part 4 was not performed due to limited enrollment as a result of early study termination.

Analysis population: Part 4 was not opened for enrollment.

Groups in this outcome

Part 4: INCB053914 50 mg BID + Azacitidine

Combination Treatment Group B INCB053914 50 mg BID + Azacitidine

Part 4: INB053914 80 mg BID + Azactidine

Combination Treatment Group B: B053914 80 mg BID + Azactidine

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 4: INCB053914 50 mg BID + Azacitidine0
Part 4: INB053914 80 mg BID + Azactidine0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
The primary efficacy endpoint of ORR in patients with AML who received INCB053914 plus azacitidine in Part 4 was not performed due to limited enrollment as a result of early study termination.
groups
  1. description
    Combination Treatment Group B INCB053914 50 mg BID + Azacitidine
    id
    OG000
    title
    Part 4: INCB053914 50 mg BID + Azacitidine
  2. description
    Combination Treatment Group B: B053914 80 mg BID + Azactidine
    id
    OG001
    title
    Part 4: INB053914 80 mg BID + Azactidine
population Description
Part 4 was not opened for enrollment.
reporting Status
POSTED
time Frame
Approximately 6 months
title
Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With Azacitidine in Subjects With Newly Diagnosed AML Who Are 65 Years or Older and Unfit for Intensive Chemotherapy Based on ORR
type
PRIMARY

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

Preserved source evidence · Not medical advice