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← TIBSOVO: refractory Myelodysplastic Syndromes with IDH1 stated without a specific alteration

NCT02719574 · STUDY IN CONTEXT

Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation

Draft scope assessment: unclear. Attached because the study's own record names IDH1. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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).

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).

→

primary · POSTED

Number of participants with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade \<1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death.

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 SAP.

→

primary · POSTED

Number of participants with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate.

SAS. Here, N=Number of participants with available data. 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.

→

primary · POSTED

Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\], Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts less than (\<) 5 percent (%) (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, absolute neutrophil count (ANC) greater than or equal to (\>=) 1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is defined as CR with unde-tectable IDH1m minimal residual disease (MRD) and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L).

Efficacy evaluable analysis set included all participants in Phase 2, Cohort 1 with confirmed IDH1-R132 who have received the first dose of FT-2102 180 days or more prior to the analysis cutoff date. This outcome measure is applicable only for Cohort 1.

→

primary · POSTED

Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\]), Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts \<5 % (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, ANC \>=1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is de-fined as CR with undetectable IDH1m MRD and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L).

FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 3, 4, 5, 6, 7 and 8. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.

→

primary · POSTED

Percentage of participants with complete remission (CR) is reported. CR is defined as bone marrow blast ≤ 5% myeloblasts with normal maturation of all cell lines, peripheral blood: Hgb ≥11 grams per deciliter (g/dL), platelets ≥ 100 × 10\^9/L, neutrophils ≥ 1.0 × 10\^9/L and blasts 0%.

FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 4 and 5. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
nct id
NCT02719574
trial label
Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
applicability
unclear
applicability note
Attached because the study's own record names IDH1. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
13
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0000
    source section id
    NCT02719574-om-0000
    source outcome index
    0
    endpoint
    Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    endpoint definition
    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).
    time origin
    Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0001
    source section id
    NCT02719574-om-0001
    source outcome index
    1
    endpoint
    Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
    endpoint definition
    Number of participants with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade \<1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death.
    time origin
    Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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 SAP.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0002
    source section id
    NCT02719574-om-0002
    source outcome index
    2
    endpoint
    Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
    endpoint definition
    Number of participants with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate.
    time origin
    Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    SAS. Here, N=Number of participants with available data. 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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0003
    source section id
    NCT02719574-om-0003
    source outcome index
    3
    endpoint
    Phase 2, Cohort 1: Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria
    endpoint definition
    Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\], Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts less than (\<) 5 percent (%) (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, absolute neutrophil count (ANC) greater than or equal to (\>=) 1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is defined as CR with unde-tectable IDH1m minimal residual disease (MRD) and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L).
    time origin
    Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Efficacy evaluable analysis set included all participants in Phase 2, Cohort 1 with confirmed IDH1-R132 who have received the first dose of FT-2102 180 days or more prior to the analysis cutoff date. This outcome measure is applicable only for Cohort 1.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0004
    source section id
    NCT02719574-om-0004
    source outcome index
    4
    endpoint
    Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Participants With CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria
    endpoint definition
    Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\]), Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts \<5 % (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, ANC \>=1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is de-fined as CR with undetectable IDH1m MRD and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L).
    time origin
    Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 3, 4, 5, 6, 7 and 8. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0005
    source section id
    NCT02719574-om-0005
    source outcome index
    5
    endpoint
    Phase 2, Cohort 4 and 5: Percentage of Participants With CR for MDS Assessed by IWG Response Criteria
    endpoint definition
    Percentage of participants with complete remission (CR) is reported. CR is defined as bone marrow blast ≤ 5% myeloblasts with normal maturation of all cell lines, peripheral blood: Hgb ≥11 grams per deciliter (g/dL), platelets ≥ 100 × 10\^9/L, neutrophils ≥ 1.0 × 10\^9/L and blasts 0%.
    time origin
    Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 4 and 5. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Phase 1: FT-2102 (Single Agent)
    regimen
    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.
    analyzed count
    16
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02719574-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Phase 1: Total FT-2102 (Single Agent)
    regimen
    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.
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02719574-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Phase 1: FT-2102 + Azacitidine (Combination Therapy)
    regimen
    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.
    analyzed count
    39
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02719574-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
    regimen
    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.
    analyzed count
    46
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02719574-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Phase 1: FT-2102 (Single Agent)
    regimen
    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.
    analyzed count
    16
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02719574-om-0001#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Phase 1: Total FT-2102 (Single Agent)
    regimen
    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.
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02719574-om-0001#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Phase 1: FT-2102 + Azacitidine (Combination Therapy)
    regimen
    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.
    analyzed count
    39
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02719574-om-0001#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0001
    arm key
    OG003
    arm label
    Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
    regimen
    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.
    analyzed count
    46
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02719574-om-0001#groups/OG003
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Phase 1: FT-2102 (Single Agent)
    regimen
    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.
    analyzed count
    15
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02719574-om-0002#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Phase 1: Total FT-2102 (Single Agent)
    regimen
    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.
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02719574-om-0002#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Phase 1: FT-2102 + Azacitidine (Combination Therapy)
    regimen
    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.
    analyzed count
    38
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02719574-om-0002#groups/OG002
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    outcome key
    om-0002
    arm key
    OG003
    arm label
    Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
    regimen
    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.
    analyzed count
    45
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02719574-om-0002#groups/OG003
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    harm key
    EG000
    source section id
    NCT02719574-ae
    event group key
    EG000
    event group label
    Phase 1: FT-2102 (Single Agent)
    serious affected
    10
    serious at risk
    16
    other affected
    15
    other at risk
    16
    frequency threshold
    5
    collection period
    From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
    event definition
    All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. 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.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    harm key
    EG001
    source section id
    NCT02719574-ae
    event group key
    EG001
    event group label
    Phase 1: Total FT-2102 (Single Agent)
    serious affected
    23
    serious at risk
    31
    other affected
    29
    other at risk
    31
    frequency threshold
    5
    collection period
    From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
    event definition
    All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. 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.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    harm key
    EG002
    source section id
    NCT02719574-ae
    event group key
    EG002
    event group label
    Phase 1: FT-2102 + Azacitidine (Combination Therapy)
    serious affected
    30
    serious at risk
    39
    other affected
    39
    other at risk
    39
    frequency threshold
    5
    collection period
    From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
    event definition
    All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. 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.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    harm key
    EG003
    source section id
    NCT02719574-ae
    event group key
    EG003
    event group label
    Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
    serious affected
    36
    serious at risk
    46
    other affected
    46
    other at risk
    46
    frequency threshold
    5
    collection period
    From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
    event definition
    All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. 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.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    harm key
    EG004
    source section id
    NCT02719574-ae
    event group key
    EG004
    event group label
    Phase 1: Overall
    serious affected
    60
    serious at risk
    78
    other affected
    76
    other at risk
    78
    frequency threshold
    5
    collection period
    From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
    event definition
    All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. 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.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    harm key
    EG005
    source section id
    NCT02719574-ae
    event group key
    EG005
    event group label
    Phase 2: Cohort 1; FT-2102 (Single Agent)
    serious affected
    115
    serious at risk
    153
    other affected
    152
    other at risk
    153
    frequency threshold
    5
    collection period
    From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
    event definition
    All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. 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.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    harm key
    EG006
    source section id
    NCT02719574-ae
    event group key
    EG006
    event group label
    Phase 2: Cohort 2; FT-2102 (Single Agent)
    serious affected
    6
    serious at risk
    18
    other affected
    18
    other at risk
    18
    frequency threshold
    5
    collection period
    From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
    event definition
    All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. 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.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    harm key
    EG007
    source section id
    NCT02719574-ae
    event group key
    EG007
    event group label
    Phase 2: Cohort 3; FT-2102 (Single Agent)
    serious affected
    4
    serious at risk
    5
    other affected
    5
    other at risk
    5
    frequency threshold
    5
    collection period
    From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
    event definition
    All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. 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.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    harm key
    EG008
    source section id
    NCT02719574-ae
    event group key
    EG008
    event group label
    Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
    serious affected
    12
    serious at risk
    20
    other affected
    18
    other at risk
    20
    frequency threshold
    5
    collection period
    From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
    event definition
    All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. 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.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    harm key
    EG009
    source section id
    NCT02719574-ae
    event group key
    EG009
    event group label
    Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
    serious affected
    18
    serious at risk
    21
    other affected
    20
    other at risk
    21
    frequency threshold
    5
    collection period
    From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
    event definition
    All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. 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.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    harm key
    EG010
    source section id
    NCT02719574-ae
    event group key
    EG010
    event group label
    Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy)
    serious affected
    13
    serious at risk
    20
    other affected
    19
    other at risk
    20
    frequency threshold
    5
    collection period
    From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
    event definition
    All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. 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.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-tibsovo-6f81a5b9
    nct id
    NCT02719574
    harm key
    EG011
    source section id
    NCT02719574-ae
    event group key
    EG011
    event group label
    Phase 2: Cohort 7; FT-2102 (Single Agent)
    serious affected
    8
    serious at risk
    10
    other affected
    10
    other at risk
    10
    frequency threshold
    5
    collection period
    From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
    event definition
    All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. 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.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice