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NCT02719574 · OUTCOME

Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)

What was measured

A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported. Safety analysis set (SAS) included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).

Analysis population: SAS analyzed. Since 150 mg BID has been established as MTD, the analysis was directed towards emphasizing findings that are most relevant for determining a safe and effective treatment strategy. Accordingly, data for the other dose levels (100 mg QD, 150 mg QD, and 300 mg QD) were combined as prespecified in statistical analysis plan (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 different 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)16
Phase 1: Total FT-2102 (Single Agent)31
Phase 1: FT-2102 + Azacitidine (Combination Therapy)39
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)46

Reported measurements

TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: FT-2102 (Single Agent)16Not reportedNot reportedNot reportedNot reported
Phase 1: Total FT-2102 (Single Agent)31Not reportedNot reportedNot reportedNot reported
Phase 1: FT-2102 + Azacitidine (Combination Therapy)39Not reportedNot reportedNot reportedNot reported
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)46Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: FT-2102 (Single Agent)10Not reportedNot reportedNot reportedNot reported
Phase 1: Total FT-2102 (Single Agent)23Not reportedNot reportedNot reportedNot reported
Phase 1: FT-2102 + Azacitidine (Combination Therapy)30Not reportedNot reportedNot reportedNot reported
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)36Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        31
      3. group Id
        OG002
        value
        39
      4. group Id
        OG003
        value
        46
    title
    TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        23
      3. group Id
        OG002
        value
        30
      4. group Id
        OG003
        value
        36
    title
    SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      31
    3. group Id
      OG002
      value
      39
    4. group Id
      OG003
      value
      46
    units
    Participants
description
A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported. Safety analysis set (SAS) included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).
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 different 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
COUNT_OF_PARTICIPANTS
population Description
SAS analyzed. Since 150 mg BID has been established as MTD, the analysis was directed towards emphasizing findings that are most relevant for determining a safe and effective treatment strategy. Accordingly, data for the other dose levels (100 mg QD, 150 mg QD, and 300 mg QD) were combined as prespecified in statistical analysis plan (SAP).
reporting Status
POSTED
time Frame
Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
title
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice