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NCT02719574 · OUTCOME

Phase 1: Time to Response (TTR ) for MDS

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
Full Range
Time frame
Phase 1: Time from first dose of study drug until documentation of the first overall response (up to 82 months)

What was measured

TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.

Analysis population: FAS. N=participants with PR or better as best overall response. 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)2
Phase 1: Total FT-2102 (Single Agent)2
Phase 1: FT-2102 + Azacitidine (Combination Therapy)6
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)6

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1: FT-2102 (Single Agent)4.65Not reported1.08.3Not reported
Phase 1: Total FT-2102 (Single Agent)4.65Not reported1.08.3Not reported
Phase 1: FT-2102 + Azacitidine (Combination Therapy)2.20Not reported1.08.5Not reported
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)2.20Not reported1.08.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        8.3
        value
        4.65
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        8.3
        value
        4.65
      3. group Id
        OG002
        lower Limit
        1.0
        upper Limit
        8.5
        value
        2.20
      4. group Id
        OG003
        lower Limit
        1.0
        upper Limit
        8.5
        value
        2.20
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    units
    Participants
description
TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
dispersion Type
Full Range
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 PR or better as best overall response. 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: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
title
Phase 1: Time to Response (TTR ) for MDS
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice