TriangleNCT02719574 · OUTCOME
Phase 1: Maximum Plasma Concentration (Cmax) 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
- Nanograms per millilitre (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
Maximum plasma concentration (Cmax) for FT-2102 is presented.
Analysis population: The 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: 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: 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: 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) | 571.5 | 53.1 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 150 mg QD (Single Agent) | 535.0 | 58.7 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 300 mg QD (Single Agent) | 708.0 | 58.2 | Not reported | Not reported | Not reported |
| Phase: FT-2102 150 mg BID (Single Agent) | 495.5 | 37.4 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy) | 543.3 | 39.8 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 150 mg BID+Azacitidine (Combination Therapy) | 439.9 | 56.2 | 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: 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) | 1913 | 47.9 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 150 mg QD (Single Agent) | 1998 | 112.9 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 300 mg QD (Single Agent) | 2907 | 36.1 | Not reported | Not reported | Not reported |
| Phase: FT-2102 150 mg BID (Single Agent) | 3703 | 20.8 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 150 mg QD+Azacitidine (Combination Therapy) | 1101 | 75.4 | Not reported | Not reported | Not reported |
| Phase 1: FT-2102 150 mg BID+Azacitidine (Combination Therapy) | 3183 | 51.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 53.1
- value
- 571.5
- group Id
- OG001
- spread
- 58.7
- value
- 535.0
- group Id
- OG002
- spread
- 58.2
- value
- 708.0
- group Id
- OG003
- spread
- 37.4
- value
- 495.5
- group Id
- OG004
- spread
- 39.8
- value
- 543.3
- group Id
- OG005
- spread
- 56.2
- value
- 439.9
- 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
- 47.9
- value
- 1913
- group Id
- OG001
- spread
- 112.9
- value
- 1998
- group Id
- OG002
- spread
- 36.1
- value
- 2907
- group Id
- OG003
- spread
- 20.8
- value
- 3703
- group Id
- OG004
- spread
- 75.4
- value
- 1101
- group Id
- OG005
- spread
- 51.5
- value
- 3183
- 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
- Maximum plasma concentration (Cmax) for FT-2102 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: 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 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: Maximum Plasma Concentration (Cmax) for FT-2102
- type
- SECONDARY
- unit Of Measure
- Nanograms per millilitre (ng/mL)
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Preserved source evidence · Not medical advice