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NCT01915498 · OUTCOME

Phase 1 Dose Escalation: Time to First Response by Total Daily Dose

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
Full Range
Time frame
Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 1 Dose Escalation was 5.0 months (range 0.4 to 34.2 months).

What was measured

Time to response is defined as the time from the date of first dose to the date of the first occurrence of response of CR, CRi, CRp, PR, mCR (for MDS) or MLFS (for AML) based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS as assessed by the Investigator.

Analysis population: Participants who received at least one dose of study treatment in Phase 1 Dose Escalation who had an objective response. Participants were grouped according to assigned total daily dose.

Groups in this outcome

Phase 1 Dose Escalation: Enasidenib 50 mg

Participants received enasidenib 50 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 60 mg

Participants received enasidenib 60 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 75 mg

Participants received enasidenib 75 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 100 mg

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

Phase 1 Dose Escalation: Enasidenib 150 mg

Participants received enasidenib 150 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 200 mg

Participants received enasidenib 200 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 300 mg

Participants received enasidenib 300 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 450 mg

Participants received enasidenib 450 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 650 mg

Participants received enasidenib 650 mg 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 1 Dose Escalation: Enasidenib 50 mg3
Phase 1 Dose Escalation: Enasidenib 60 mg3
Phase 1 Dose Escalation: Enasidenib 75 mg1
Phase 1 Dose Escalation: Enasidenib 100 mg13
Phase 1 Dose Escalation: Enasidenib 150 mg6
Phase 1 Dose Escalation: Enasidenib 200 mg11
Phase 1 Dose Escalation: Enasidenib 300 mg5
Phase 1 Dose Escalation: Enasidenib 450 mg3
Phase 1 Dose Escalation: Enasidenib 650 mg5

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1 Dose Escalation: Enasidenib 50 mg3.8Not reported1.04.2Not reported
Phase 1 Dose Escalation: Enasidenib 60 mg1.9Not reported1.03.8Not reported
Phase 1 Dose Escalation: Enasidenib 75 mg0.9Not reported0.90.9Not reported
Phase 1 Dose Escalation: Enasidenib 100 mg1.8Not reported0.65.6Not reported
Phase 1 Dose Escalation: Enasidenib 150 mg2.0Not reported0.68.6Not reported
Phase 1 Dose Escalation: Enasidenib 200 mg1.9Not reported0.55.7Not reported
Phase 1 Dose Escalation: Enasidenib 300 mg2.1Not reported1.03.7Not reported
Phase 1 Dose Escalation: Enasidenib 450 mg2.8Not reported0.53.8Not reported
Phase 1 Dose Escalation: Enasidenib 650 mg1.9Not reported0.53.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        4.2
        value
        3.8
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        3.8
        value
        1.9
      3. group Id
        OG002
        lower Limit
        0.9
        upper Limit
        0.9
        value
        0.9
      4. group Id
        OG003
        lower Limit
        0.6
        upper Limit
        5.6
        value
        1.8
      5. group Id
        OG004
        lower Limit
        0.6
        upper Limit
        8.6
        value
        2.0
      6. group Id
        OG005
        lower Limit
        0.5
        upper Limit
        5.7
        value
        1.9
      7. group Id
        OG006
        lower Limit
        1.0
        upper Limit
        3.7
        value
        2.1
      8. group Id
        OG007
        lower Limit
        0.5
        upper Limit
        3.8
        value
        2.8
      9. group Id
        OG008
        lower Limit
        0.5
        upper Limit
        3.8
        value
        1.9
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      13
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      11
    7. group Id
      OG006
      value
      5
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      5
    units
    Participants
description
Time to response is defined as the time from the date of first dose to the date of the first occurrence of response of CR, CRi, CRp, PR, mCR (for MDS) or MLFS (for AML) based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS as assessed by the Investigator.
dispersion Type
Full Range
groups
  1. description
    Participants received enasidenib 50 mg tablets 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 1 Dose Escalation: Enasidenib 50 mg
  2. description
    Participants received enasidenib 60 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG001
    title
    Phase 1 Dose Escalation: Enasidenib 60 mg
  3. description
    Participants received enasidenib 75 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG002
    title
    Phase 1 Dose Escalation: Enasidenib 75 mg
  4. description
    Participants received enasidenib 100 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG003
    title
    Phase 1 Dose Escalation: Enasidenib 100 mg
  5. description
    Participants received enasidenib 150 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG004
    title
    Phase 1 Dose Escalation: Enasidenib 150 mg
  6. description
    Participants received enasidenib 200 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG005
    title
    Phase 1 Dose Escalation: Enasidenib 200 mg
  7. description
    Participants received enasidenib 300 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG006
    title
    Phase 1 Dose Escalation: Enasidenib 300 mg
  8. description
    Participants received enasidenib 450 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG007
    title
    Phase 1 Dose Escalation: Enasidenib 450 mg
  9. description
    Participants received enasidenib 650 mg on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG008
    title
    Phase 1 Dose Escalation: Enasidenib 650 mg
param Type
MEDIAN
population Description
Participants who received at least one dose of study treatment in Phase 1 Dose Escalation who had an objective response. Participants were grouped according to assigned total daily dose.
reporting Status
POSTED
time Frame
Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 1 Dose Escalation was 5.0 months (range 0.4 to 34.2 months).
title
Phase 1 Dose Escalation: Time to First Response by Total Daily Dose
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice