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NCT02719574 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      8
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      4
    5. group Id
      BG004
      value
      7
    6. group Id
      BG005
      value
      8
    7. group Id
      BG006
      value
      9
    8. group Id
      BG007
      value
      31
    9. group Id
      BG008
      value
      1
    10. group Id
      BG009
      value
      153
    11. group Id
      BG010
      value
      18
    12. group Id
      BG011
      value
      5
    units
    Participants
groups
  1. description
    Participants with AML or MDS received single agent of FT-2102 100 mg orally QD in 28-day cycles until MTD or MED achieved.
    id
    BG000
    title
    Phase 1: FT-2102 100mg QD (Single Agent; Dose Escalation)
  2. description
    Participants with AML or MDS received single agent of FT-2102 150 mg orally QD in 28-day cycles until MTD or MED achieved.
    id
    BG001
    title
    Phase 1: FT-2102 150mg QD (Single Agent; Dose Escalation)
  3. description
    Participants with AML or MDS received single agent of FT-2102 150 mg orally BID in 28-day cycles until MTD or MED achieved.
    id
    BG002
    title
    Phase 1: FT-2102 150mg BID (Single Agent; Dose Escalation)
  4. description
    Participants with AML or MDS received single agent of FT-2102 300 mg orally QD in 28-day cycles until MTD or MED achieved.
    id
    BG003
    title
    Phase 1: FT-2102 300mg QD (Single Agent; Dose Escalation)
  5. description
    Participants with AML or MDS received combination therapy (FT-2102 150 mg QD 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
    BG004
    title
    Phase 1: FT-2102 150mg QD+Azacitidine (Combination Therapy; Dose Escalation)
  6. description
    Participants with AML or MDS received combination therapy (FT-2102 150 mg BID 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
    BG005
    title
    Phase 1: FT-2102 150mg BID+Azacitidine (Combination Therapy; Dose Escalation)
  7. description
    Participants with AML or MDS received single agent of FT-2102 150 mg orally BID in 28-day cycles until MTD or MED achieved.
    id
    BG006
    title
    Phase 1: FT-2102 150mg BID (Single Agent; Dose Expansion)
  8. description
    Participants with AML or MDS received combination therapy (FT-2102 150 mg BID 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
    BG007
    title
    Phase 1: FT-2102 150mg BID+Azacitidine (Combination Therapy; Dose Expansion)
  9. description
    Participants with AML harboring IDH1 mutation received FT-2102 150 mg BID in combination with LDAC administered at the dose of 20 mg BID SC for 10 days every 28-day cycle until treatment discontinuation.
    id
    BG008
    title
    Phase 1: FT-2102 150mg BID+ Cytarabine (Combination Therapy; Dose Expansion)
  10. description
    Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
    id
    BG009
    title
    Phase 2: Cohort 1; FT-2102 (Single Agent)
  11. description
    Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
    id
    BG010
    title
    Phase 2: Cohort 2; FT-2102 (Single Agent)
  12. description
    Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
    id
    BG011
    title
    Phase 2: Cohort 3; FT-2102 (Single Agent)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          37
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          1
        title
        <65 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          14
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          68
        11. group Id
          BG010
          value
          11
        12. group Id
          BG011
          value
          3
        title
        65 - <75 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          48
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          1
        title
        >=75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          14
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          74
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          2
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          17
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          79
        11. group Id
          BG010
          value
          12
        12. group Id
          BG011
          value
          3
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          19
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          71
        11. group Id
          BG010
          value
          10
        12. group Id
          BG011
          value
          4
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          16
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          56
        11. group Id
          BG010
          value
          7
        12. group Id
          BG011
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS) included all the participants who were enrolled in the study and have received at least one dose of FT-2102.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      8
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      4
    5. group Id
      BG004
      value
      7
    6. group Id
      BG005
      value
      8
    7. group Id
      BG006
      value
      9
    8. group Id
      BG007
      value
      31
    9. group Id
      BG008
      value
      1
    10. group Id
      BG009
      value
      153
    11. group Id
      BG010
      value
      18
    12. group Id
      BG011
      value
      5
    units
    Participants
groups
  1. description
    Participants with AML or MDS received single agent of FT-2102 100 mg orally QD in 28-day cycles until MTD or MED achieved.
    id
    BG000
    title
    Phase 1: FT-2102 100mg QD (Single Agent; Dose Escalation)
  2. description
    Participants with AML or MDS received single agent of FT-2102 150 mg orally QD in 28-day cycles until MTD or MED achieved.
    id
    BG001
    title
    Phase 1: FT-2102 150mg QD (Single Agent; Dose Escalation)
  3. description
    Participants with AML or MDS received single agent of FT-2102 150 mg orally BID in 28-day cycles until MTD or MED achieved.
    id
    BG002
    title
    Phase 1: FT-2102 150mg BID (Single Agent; Dose Escalation)
  4. description
    Participants with AML or MDS received single agent of FT-2102 300 mg orally QD in 28-day cycles until MTD or MED achieved.
    id
    BG003
    title
    Phase 1: FT-2102 300mg QD (Single Agent; Dose Escalation)
  5. description
    Participants with AML or MDS received combination therapy (FT-2102 150 mg QD 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
    BG004
    title
    Phase 1: FT-2102 150mg QD+Azacitidine (Combination Therapy; Dose Escalation)
  6. description
    Participants with AML or MDS received combination therapy (FT-2102 150 mg BID 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
    BG005
    title
    Phase 1: FT-2102 150mg BID+Azacitidine (Combination Therapy; Dose Escalation)
  7. description
    Participants with AML or MDS received single agent of FT-2102 150 mg orally BID in 28-day cycles until MTD or MED achieved.
    id
    BG006
    title
    Phase 1: FT-2102 150mg BID (Single Agent; Dose Expansion)
  8. description
    Participants with AML or MDS received combination therapy (FT-2102 150 mg BID 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
    BG007
    title
    Phase 1: FT-2102 150mg BID+Azacitidine (Combination Therapy; Dose Expansion)
  9. description
    Participants with AML harboring IDH1 mutation received FT-2102 150 mg BID in combination with LDAC administered at the dose of 20 mg BID SC for 10 days every 28-day cycle until treatment discontinuation.
    id
    BG008
    title
    Phase 1: FT-2102 150mg BID+ Cytarabine (Combination Therapy; Dose Expansion)
  10. description
    Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
    id
    BG009
    title
    Phase 2: Cohort 1; FT-2102 (Single Agent)
  11. description
    Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
    id
    BG010
    title
    Phase 2: Cohort 2; FT-2102 (Single Agent)
  12. description
    Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
    id
    BG011
    title
    Phase 2: Cohort 3; FT-2102 (Single Agent)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          37
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          1
        title
        <65 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          14
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          68
        11. group Id
          BG010
          value
          11
        12. group Id
          BG011
          value
          3
        title
        65 - <75 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          48
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          1
        title
        >=75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          14
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          74
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          2
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          17
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          79
        11. group Id
          BG010
          value
          12
        12. group Id
          BG011
          value
          3
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          19
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          71
        11. group Id
          BG010
          value
          10
        12. group Id
          BG011
          value
          4
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          16
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          56
        11. group Id
          BG010
          value
          7
        12. group Id
          BG011
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS) included all the participants who were enrolled in the study and have received at least one dose of FT-2102.

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Preserved source evidence · Not medical advice