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NCT02719574 · OUTCOME

Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102

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
hour
Interval / dispersion
Full Range
Time frame
Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)

What was measured

Time to reach the maximum plasma concentration (Tmax) is presented.

Analysis population: The PK analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylzed (n) = participants with available data for specific timepoints.

Groups in this outcome

Phase 1: FT-2102 100 mg QD (Single Agent)

Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose level of 100 mg until MTD or MED achieved.

Phase 1: FT-2102 150 mg QD (Single Agent)

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

Phase 1: FT-2102 300 mg QD (Single Agent)

Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 300 mg until MTD or MED achieved.

Phase 1: FT-2102 150 mg BID (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 MTD or MED achieved.

Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy)

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

Phase 1: FT-2102 150 mg BID+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.

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 100 mg QD (Single Agent)3
Phase 1: FT-2102 150 mg QD (Single Agent)8
Phase 1: FT-2102 300 mg QD (Single Agent)4
Phase 1: FT-2102 150 mg BID (Single Agent)6
Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy)7
Phase 1: FT-2102 150 mg BID+Azacitidine (Combination Therapy)8

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Phase 1: FT-2102 100 mg QD (Single Agent)3
Phase 1: FT-2102 150 mg QD (Single Agent)8
Phase 1: FT-2102 300 mg QD (Single Agent)4
Phase 1: FT-2102 150 mg BID (Single Agent)6
Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy)7
Phase 1: FT-2102 150 mg BID+Azacitidine (Combination Therapy)8
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1: FT-2102 100 mg QD (Single Agent)4.05Not reported2.224.12Not reported
Phase 1: FT-2102 150 mg QD (Single Agent)4.00Not reported2.0224.00Not reported
Phase 1: FT-2102 300 mg QD (Single Agent)23.83Not reported4.0024.00Not reported
Phase 1: FT-2102 150 mg BID (Single Agent)5.79Not reported1.007.83Not reported
Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy)4.02Not reported2.0022.55Not reported
Phase 1: FT-2102 150 mg BID+Azacitidine (Combination Therapy)3.13Not reported2.034.12Not reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Phase 1: FT-2102 100 mg QD (Single Agent)3
Phase 1: FT-2102 150 mg QD (Single Agent)5
Phase 1: FT-2102 300 mg QD (Single Agent)4
Phase 1: FT-2102 150 mg BID (Single Agent)6
Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy)6
Phase 1: FT-2102 150 mg BID+Azacitidine (Combination Therapy)5
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1: FT-2102 100 mg QD (Single Agent)2.23Not reported2.134.00Not reported
Phase 1: FT-2102 150 mg QD (Single Agent)2.00Not reported1.002.12Not reported
Phase 1: FT-2102 300 mg QD (Single Agent)1.00Not reported0.001.08Not reported
Phase 1: FT-2102 150 mg BID (Single Agent)3.00Not reported0.007.50Not reported
Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy)2.29Not reported2.004.00Not reported
Phase 1: FT-2102 150 mg BID+Azacitidine (Combination Therapy)1.18Not reported0.002.07Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.22
        upper Limit
        4.12
        value
        4.05
      2. group Id
        OG001
        lower Limit
        2.02
        upper Limit
        24.00
        value
        4.00
      3. group Id
        OG002
        lower Limit
        4.00
        upper Limit
        24.00
        value
        23.83
      4. group Id
        OG003
        lower Limit
        1.00
        upper Limit
        7.83
        value
        5.79
      5. group Id
        OG004
        lower Limit
        2.00
        upper Limit
        22.55
        value
        4.02
      6. group Id
        OG005
        lower Limit
        2.03
        upper Limit
        4.12
        value
        3.13
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        8
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.13
        upper Limit
        4.00
        value
        2.23
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        2.12
        value
        2.00
      3. group Id
        OG002
        lower Limit
        0.00
        upper Limit
        1.08
        value
        1.00
      4. group Id
        OG003
        lower Limit
        0.00
        upper Limit
        7.50
        value
        3.00
      5. group Id
        OG004
        lower Limit
        2.00
        upper Limit
        4.00
        value
        2.29
      6. group Id
        OG005
        lower Limit
        0.00
        upper Limit
        2.07
        value
        1.18
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        5
      units
      Participants
    title
    Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      8
    units
    Participants
description
Time to reach the maximum plasma concentration (Tmax) is presented.
dispersion Type
Full Range
groups
  1. description
    Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose level of 100 mg until MTD or MED achieved.
    id
    OG000
    title
    Phase 1: FT-2102 100 mg QD (Single Agent)
  2. description
    Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
    id
    OG001
    title
    Phase 1: FT-2102 150 mg QD (Single Agent)
  3. description
    Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 300 mg until MTD or MED achieved.
    id
    OG002
    title
    Phase 1: FT-2102 300 mg QD (Single Agent)
  4. description
    Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
    id
    OG003
    title
    Phase 1: FT-2102 150 mg BID (Single Agent)
  5. description
    Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m\^2) orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved
    id
    OG004
    title
    Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy)
  6. 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
    OG005
    title
    Phase 1: FT-2102 150 mg BID+Azacitidine (Combination Therapy)
param Type
MEDIAN
population Description
The PK analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylzed (n) = participants with available data for specific timepoints.
reporting Status
POSTED
time Frame
Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
title
Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102
type
SECONDARY
unit Of Measure
hour

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Preserved source evidence · Not medical advice