TriangleNCT02719574 · OUTCOME
Phase 1: Area Under the Curve (AUClast) for FT-2102
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Hour*nanograms per millilitre (h*ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
What was measured
Area under the plasma concentration-time curve from zero time until the last measurable concentration is presented.
Analysis population: The pharmacokinetic (PK) analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylzed (n) = participants with available data for specific timepoints.
Groups in this outcome
Phase 1: FT-2102 100 mg QD (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose level of 100 mg until MTD or MED achieved.
Phase 1: FT-2102 150 mg QD (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
Phase 1: FT-2102 300 mg QD (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 300 mg until MTD or MED achieved.
Phase 1: FT-2102 150 mg BID (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 MTD or MED achieved.
Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy)
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m\^2) orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved
Phase 1: FT-2102 150 mg BID+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.
| Group | Source count |
|---|---|
| Phase 1: FT-2102 100 mg QD (Single Agent) | 3 |
| Phase 1: FT-2102 150 mg QD (Single Agent) | 8 |
| Phase 1: FT-2102 300 mg QD (Single Agent) | 4 |
| Phase 1: FT-2102 150 mg BID (Single Agent) | 6 |
| Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy) | 7 |
| Phase 1: FT-2102 150 mg BID+Azacitidine (Combination Therapy) | 8 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Phase 1: FT-2102 100 mg QD (Single Agent) | 3 |
| Phase 1: FT-2102 150 mg QD (Single Agent) | 8 |
| Phase 1: FT-2102 300 mg QD (Single Agent) | 4 |
| Phase 1: FT-2102 150 mg BID (Single Agent) | 6 |
| Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy) | 7 |
| Phase 1: FT-2102 150 mg BID+Azacitidine (Combination Therapy) | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: FT-2102 100 mg QD (Single Agent) | 5505 | 146.9 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 150 mg QD (Single Agent) | 8955 | 63.7 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 300 mg QD (Single Agent) | 12100 | 75.4 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 150 mg BID (Single Agent) | 2538 | 34.2 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy) | 8529 | 51.1 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 150 mg BID+Azacitidine (Combination Therapy) | 2288 | 71.7 | Not reported | Not reported | Not reported |
Cycle 2 Day 1
| Group | Source count |
|---|---|
| Phase 1: FT-2102 100 mg QD (Single Agent) | 3 |
| Phase 1: FT-2102 150 mg QD (Single Agent) | 5 |
| Phase 1: FT-2102 300 mg QD (Single Agent) | 4 |
| Phase 1: FT-2102 150 mg BID (Single Agent) | 6 |
| Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy) | 6 |
| Phase 1: FT-2102 150 mg BID+Azacitidine (Combination Therapy) | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: FT-2102 100 mg QD (Single Agent) | 13080 | 63.5 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 150 mg QD (Single Agent) | 14130 | 124.0 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 300 mg QD (Single Agent) | 19140 | 24.0 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 150 mg BID (Single Agent) | 26360 | 22.3 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy) | 7468 | 92.6 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 150 mg BID+Azacitidine (Combination Therapy) | 20640 | 71.0 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 146.9
- value
- 5505
- group Id
- OG001
- spread
- 63.7
- value
- 8955
- group Id
- OG002
- spread
- 75.4
- value
- 12100
- group Id
- OG003
- spread
- 34.2
- value
- 2538
- group Id
- OG004
- spread
- 51.1
- value
- 8529
- group Id
- OG005
- spread
- 71.7
- value
- 2288
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 8
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 63.5
- value
- 13080
- group Id
- OG001
- spread
- 124.0
- value
- 14130
- group Id
- OG002
- spread
- 24.0
- value
- 19140
- group Id
- OG003
- spread
- 22.3
- value
- 26360
- group Id
- OG004
- spread
- 92.6
- value
- 7468
- group Id
- OG005
- spread
- 71.0
- value
- 20640
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 5
- units
- Participants
- title
- Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 8
- units
- Participants
- description
- Area under the plasma concentration-time curve from zero time until the last measurable concentration is presented.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose level of 100 mg until MTD or MED achieved.
- id
- OG000
- title
- Phase 1: FT-2102 100 mg QD (Single Agent)
- description
- Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
- id
- OG001
- title
- Phase 1: FT-2102 150 mg QD (Single Agent)
- description
- Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 300 mg until MTD or MED achieved.
- id
- OG002
- title
- Phase 1: FT-2102 300 mg QD (Single Agent)
- description
- Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
- id
- OG003
- title
- Phase 1: FT-2102 150 mg BID (Single Agent)
- description
- Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m\^2) orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved
- id
- OG004
- title
- Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy)
- 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
- OG005
- title
- Phase 1: FT-2102 150 mg BID+Azacitidine (Combination Therapy)
- param Type
- GEOMETRIC_MEAN
- population Description
- The pharmacokinetic (PK) analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylzed (n) = participants with available data for specific timepoints.
- reporting Status
- POSTED
- time Frame
- Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
- title
- Phase 1: Area Under the Curve (AUClast) for FT-2102
- type
- SECONDARY
- unit Of Measure
- Hour*nanograms per millilitre (h*ng/mL)
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Preserved source evidence · Not medical advice