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NCT01915498 · OUTCOME

Phase 1 Dose Expansion: Time to 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
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 Part 1 Dose Expansion was 5.2 months (range 0.5 to 32.8 months).

What was measured

Time to complete response is defined as the time from the date of the first dose to the date of the first complete response based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS per investigator assessment.

Analysis population: Participants who received at least one dose of study treatment in Phase 1 Dose Expansion who had a complete response.

Groups in this outcome

Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD

Participants ≥ 60 years old with relapsed, refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD

Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD

Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD

Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib 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 1 Dose Expansion Arm 1: Enasidenib 100 mg QD11
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD0
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD5
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD6

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD3.7Not reported1.011.2Not reported
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD5.6Not reported3.412.9Not reported
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD9.4Not reported1.814.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        11.2
        value
        3.7
      2. group Id
        OG002
        lower Limit
        3.4
        upper Limit
        12.9
        value
        5.6
      3. group Id
        OG003
        lower Limit
        1.8
        upper Limit
        14.7
        value
        9.4
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      6
    units
    Participants
description
Time to complete response is defined as the time from the date of the first dose to the date of the first complete response based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS per investigator assessment.
dispersion Type
Full Range
groups
  1. description
    Participants ≥ 60 years old with relapsed, refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib 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 Expansion Arm 1: Enasidenib 100 mg QD
  2. description
    Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD 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 Expansion Arm 2: Enasidenib 100 mg QD
  3. description
    Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD 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 Expansion Arm 3: Enasidenib 100 mg QD
  4. description
    Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD 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 Expansion Arm 4: Enasidenib 100 mg QD
param Type
MEDIAN
population Description
Participants who received at least one dose of study treatment in Phase 1 Dose Expansion who had a complete response.
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 Part 1 Dose Expansion was 5.2 months (range 0.5 to 32.8 months).
title
Phase 1 Dose Expansion: Time to Complete Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice