TriangleNCT02719574 · OUTCOME
Phase 1: 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 1: 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: 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.
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 differ-ent 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 | Source count |
|---|---|
| Phase 1: FT-2102 (Single Agent) | 15 |
| Phase 1: Total FT-2102 (Single Agent) | 30 |
| Phase 1: FT-2102 + Azacitidine (Combination Therapy) | 38 |
| Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) | 45 |
Reported measurements
<=450 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: FT-2102 (Single Agent) | 10 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Total FT-2102 (Single Agent) | 16 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 + Azacitidine (Combination Therapy) | 23 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) | 26 | Not reported | Not reported | Not reported | Not reported |
>450 to <=480 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: FT-2102 (Single Agent) | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Total FT-2102 (Single Agent) | 11 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 + Azacitidine (Combination Therapy) | 10 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) | 13 | Not reported | Not reported | Not reported | Not reported |
>480 to <=500 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: FT-2102 (Single Agent) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Total FT-2102 (Single Agent) | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 + Azacitidine (Combination Therapy) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) | 2 | Not reported | Not reported | Not reported | Not reported |
>500 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: FT-2102 (Single Agent) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Total FT-2102 (Single Agent) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 + Azacitidine (Combination Therapy) | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) | 4 | Not reported | Not reported | Not reported | Not reported |
>30 to <=60 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: FT-2102 (Single Agent) | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Total FT-2102 (Single Agent) | 8 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 + Azacitidine (Combination Therapy) | 13 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) | 14 | Not reported | Not reported | Not reported | Not reported |
>60 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: FT-2102 (Single Agent) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Total FT-2102 (Single Agent) | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 + Azacitidine (Combination Therapy) | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 26
- title
- <=450 msec
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 13
- title
- >450 to <=480 msec
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- title
- >480 to <=500 msec
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- title
- >500 msec
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 14
- title
- >30 to <=60 msec
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 6
- title
- >60 msec
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 38
- group Id
- OG003
- value
- 45
- 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 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)
- description
- 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.
- id
- OG001
- title
- Phase 1: Total FT-2102 (Single Agent)
- 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)
- 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. 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.
- reporting Status
- POSTED
- time Frame
- Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)
- title
- Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice