Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01915498 · OUTCOME

Phase 2 Dose Expansion: Duration of Complete Response

Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation · Source last updated 2024-10-22

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
From first dose of study treatment to the data cut-off date of 01 September 2017; median time on follow-up in Phase 2 was 5.8 months (range 0.4 to 22.5 months).

What was measured

Among participants who had a response of CR based on the 2003 revised IWG criteria for AML assessed by the Investigator, duration of complete response was calculated from the date of the first occurrence of complete response to the date of documented disease relapse, progression or death, whichever occurred earlier. DOCR was estimated using the Kaplan-Meier method. Participants without relapse, progressive disease, or death due to any cause were censored at the date of the last adequate response assessment.

Analysis population: Participants in Phase 2 with R/R AML who received at least one dose of study treatment and who had a complete response.

Groups in this outcome

Phase 2: Enasidenib 100 mg QD

Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Phase 2: Enasidenib 100 mg QD21

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD4.6Not reported2.86.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.8
        upper Limit
        6.5
        value
        4.6
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
Among participants who had a response of CR based on the 2003 revised IWG criteria for AML assessed by the Investigator, duration of complete response was calculated from the date of the first occurrence of complete response to the date of documented disease relapse, progression or death, whichever occurred earlier. DOCR was estimated using the Kaplan-Meier method. Participants without relapse, progressive disease, or death due to any cause were censored at the date of the last adequate response assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG000
    title
    Phase 2: Enasidenib 100 mg QD
param Type
MEDIAN
population Description
Participants in Phase 2 with R/R AML who received at least one dose of study treatment and who had a complete response.
reporting Status
POSTED
time Frame
From first dose of study treatment to the data cut-off date of 01 September 2017; median time on follow-up in Phase 2 was 5.8 months (range 0.4 to 22.5 months).
title
Phase 2 Dose Expansion: Duration of Complete Response
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice