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NCT02719574 · OUTCOME

Phase 1: Duration of Overall Response for AML

Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation · Source last updated 2026-06-29

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
Phase 1: From date of the first response to the date of the relapse or death (up to 82 months)

What was measured

Duration of response is defined as the time from the date of the first response to the date of the relapse or death. The estimation of median duration of overall response was done by Kaplan-Meier method.

Analysis population: FAS. N=participants with available data for this outcome measure. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD)were combined as prespecified in SAP.

Groups in this outcome

Phase 1: FT-2102 (Single Agent)

Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.

Phase 1: Total FT-2102 (Single Agent)

Participants with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the differ-ent dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.

Phase 1: FT-2102 + Azacitidine (Combination Therapy)

Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m\^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)

Participants with AML or MDS received combination therapy (FT-2102 150 mg and ≤ 300 mg and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.

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: FT-2102 (Single Agent)5
Phase 1: Total FT-2102 (Single Agent)10
Phase 1: FT-2102 + Azacitidine (Combination Therapy)18
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)22

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1: FT-2102 (Single Agent)3.60Not reported1.70NASince the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
Phase 1: Total FT-2102 (Single Agent)2.90Not reported0.906.40Not reported
Phase 1: FT-2102 + Azacitidine (Combination Therapy)22.00Not reported3.20NASince the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)22.00Not reported3.20NASince the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
        group Id
        OG000
        lower Limit
        1.70
        upper Limit
        NA
        value
        3.60
      2. group Id
        OG001
        lower Limit
        0.90
        upper Limit
        6.40
        value
        2.90
      3. comment
        Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
        group Id
        OG002
        lower Limit
        3.20
        upper Limit
        NA
        value
        22.00
      4. comment
        Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
        group Id
        OG003
        lower Limit
        3.20
        upper Limit
        NA
        value
        22.00
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      18
    4. group Id
      OG003
      value
      22
    units
    Participants
description
Duration of response is defined as the time from the date of the first response to the date of the relapse or death. The estimation of median duration of overall response was done by Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
    id
    OG000
    title
    Phase 1: FT-2102 (Single Agent)
  2. description
    Participants with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the differ-ent dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.
    id
    OG001
    title
    Phase 1: Total FT-2102 (Single Agent)
  3. description
    Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m\^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
    id
    OG002
    title
    Phase 1: FT-2102 + Azacitidine (Combination Therapy)
  4. description
    Participants with AML or MDS received combination therapy (FT-2102 150 mg and ≤ 300 mg and azacitidine administered at the dose of 75 mg/m\^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
    id
    OG003
    title
    Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
param Type
MEDIAN
population Description
FAS. N=participants with available data for this outcome measure. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD)were combined as prespecified in SAP.
reporting Status
POSTED
time Frame
Phase 1: From date of the first response to the date of the relapse or death (up to 82 months)
title
Phase 1: Duration of Overall Response for AML
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice