TriangleNCT02719574 · OUTCOME
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
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 2: From Baseline up to 28 days after last dose of study drug (up to 82 months)
What was measured
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.
Analysis population: Safety analysis set included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine). Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
Groups in this outcome
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Phase 2: Cohort 2; FT-2102 (Single Agent)
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.
Phase 2: Cohort 3; FT-2102 (Single Agent)
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.
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
| Group | Source count |
|---|---|
| Phase 2: Cohort 1; FT-2102 (Single Agent) | 151 |
| Phase 2: Cohort 2; FT-2102 (Single Agent) | 17 |
| Phase 2: Cohort 3; FT-2102 (Single Agent) | 5 |
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 18 |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 21 |
| Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) | 20 |
| Phase 2: Cohort 7; FT-2102 (Single Agent) | 10 |
| Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) | 11 |
Reported measurements
<=450 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 1; FT-2102 (Single Agent) | 90 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 2; FT-2102 (Single Agent) | 11 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 3; FT-2102 (Single Agent) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) | 11 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 7; FT-2102 (Single Agent) | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) | 4 | Not reported | Not reported | Not reported | Not reported |
>450 to <=480 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 1; FT-2102 (Single Agent) | 44 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 2; FT-2102 (Single Agent) | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 3; FT-2102 (Single Agent) | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 7; FT-2102 (Single Agent) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) | 4 | Not reported | Not reported | Not reported | Not reported |
>480 to <=500 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 1; FT-2102 (Single Agent) | 12 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 2; FT-2102 (Single Agent) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 3; FT-2102 (Single Agent) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 7; FT-2102 (Single Agent) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) | 1 | Not reported | Not reported | Not reported | Not reported |
>500 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 1; FT-2102 (Single Agent) | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 2; FT-2102 (Single Agent) | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 3; FT-2102 (Single Agent) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 7; FT-2102 (Single Agent) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) | 2 | Not reported | Not reported | Not reported | Not reported |
>30 to <=60 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 1; FT-2102 (Single Agent) | 43 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 2; FT-2102 (Single Agent) | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 3; FT-2102 (Single Agent) | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 7; FT-2102 (Single Agent) | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) | 1 | Not reported | Not reported | Not reported | Not reported |
>60 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 1; FT-2102 (Single Agent) | 10 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 2; FT-2102 (Single Agent) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 3; FT-2102 (Single Agent) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 7; FT-2102 (Single Agent) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 90
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 4
- title
- <=450 msec
- categories
- measurements
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 4
- title
- >450 to <=480 msec
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- title
- >480 to <=500 msec
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- title
- >500 msec
- categories
- measurements
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 1
- title
- >30 to <=60 msec
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 5
- title
- >60 msec
- denoms
- counts
- group Id
- OG000
- value
- 151
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 18
- group Id
- OG004
- value
- 21
- group Id
- OG005
- value
- 20
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 11
- units
- Participants
- description
- 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.
- groups
- description
- Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
- id
- OG000
- title
- Phase 2: Cohort 1; FT-2102 (Single Agent)
- 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
- OG001
- title
- Phase 2: Cohort 2; FT-2102 (Single Agent)
- 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
- OG002
- title
- Phase 2: Cohort 3; FT-2102 (Single Agent)
- description
- Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
- id
- OG003
- title
- Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
- description
- Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
- id
- OG004
- title
- Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
- description
- Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
- id
- OG005
- title
- Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy)
- description
- Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
- id
- OG006
- title
- Phase 2: Cohort 7; FT-2102 (Single Agent)
- description
- Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
- id
- OG007
- title
- Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine). Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Phase 2: From Baseline up to 28 days after last dose of study drug (up to 82 months)
- title
- Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice