TriangleNCT02719574 · OUTCOME
Phase 2: 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
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
What was measured
Maximum Plasma Concentartion (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, Overall Number of Participants Analyzed (N) and number analyzed (n) = participants with available data for specific timepoints.
Groups in this outcome
Phase 2: Cohort 1; FT-2102 150 mg BID (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 150 mg BID (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 150 mg BID (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 150 mg BID + 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 150 mg BID + 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 150 mg BID + 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 150 mg BID (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 150 mg BID + 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 150 mg BID (Single Agent) | 120 |
| Phase 2: Cohort 2; FT-2102 150 mg BID (Single Agent) | 14 |
| Phase 2: Cohort 3; FT-2102 150 mg BID (Single Agent) | 2 |
| Phase 2: Cohort 4; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 13 |
| Phase 2: Cohort 5; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 16 |
| Phase 2: Cohort 6; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 4 |
| Phase 2: Cohort 7; FT-2102 150 mg BID (Single Agent) | 2 |
| Phase 2: Cohort 8; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 1 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Phase 2: Cohort 1; FT-2102 150 mg BID (Single Agent) | 120 |
| Phase 2: Cohort 2; FT-2102 150 mg BID (Single Agent) | 14 |
| Phase 2: Cohort 3; FT-2102 150 mg BID (Single Agent) | 2 |
| Phase 2: Cohort 4; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 13 |
| Phase 2: Cohort 5; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 16 |
| Phase 2: Cohort 6; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 3 |
| Phase 2: Cohort 7; FT-2102 150 mg BID (Single Agent) | 2 |
| Phase 2: Cohort 8; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 1; FT-2102 150 mg BID (Single Agent) | 534.5 | 57.5 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 2; FT-2102 150 mg BID (Single Agent) | 492.4 | 29.3 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 3; FT-2102 150 mg BID (Single Agent) | 388.8 | 49.1 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 4; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 623.2 | 75.8 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 5; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 404.1 | 58.5 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 6; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 411.2 | 9.0 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 7; FT-2102 150 mg BID (Single Agent) | 747.5 | 107.6 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 8; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 671 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated due to small number of participants. |
Cycle 2 Day 1
| Group | Source count |
|---|---|
| Phase 2: Cohort 1; FT-2102 150 mg BID (Single Agent) | 88 |
| Phase 2: Cohort 2; FT-2102 150 mg BID (Single Agent) | 12 |
| Phase 2: Cohort 3; FT-2102 150 mg BID (Single Agent) | 0 |
| Phase 2: Cohort 4; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 11 |
| Phase 2: Cohort 5; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 14 |
| Phase 2: Cohort 6; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 4 |
| Phase 2: Cohort 7; FT-2102 150 mg BID (Single Agent) | 1 |
| Phase 2: Cohort 8; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 1; FT-2102 150 mg BID (Single Agent) | 3136 | 62.0 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 2; FT-2102 150 mg BID (Single Agent) | 3800 | 14.7 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 4; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 3239 | 68.7 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 5; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 2934 | 53.6 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 6; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 3043 | 39.3 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 7; FT-2102 150 mg BID (Single Agent) | 3500 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated due to small number of participants. |
| Phase 2: Cohort 8; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 3080 | NA | Not reported | Not reported | Geometric coefficient of variation could not be calculated due to small number of participants. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 57.5
- value
- 534.5
- group Id
- OG001
- spread
- 29.3
- value
- 492.4
- group Id
- OG002
- spread
- 49.1
- value
- 388.8
- group Id
- OG003
- spread
- 75.8
- value
- 623.2
- group Id
- OG004
- spread
- 58.5
- value
- 404.1
- group Id
- OG005
- spread
- 9.0
- value
- 411.2
- group Id
- OG006
- spread
- 107.6
- value
- 747.5
- comment
- Geometric coefficient of variation could not be calculated due to small number of participants.
- group Id
- OG007
- spread
- NA
- value
- 671
- denoms
- counts
- group Id
- OG000
- value
- 120
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 62.0
- value
- 3136
- group Id
- OG001
- spread
- 14.7
- value
- 3800
- group Id
- OG003
- spread
- 68.7
- value
- 3239
- group Id
- OG004
- spread
- 53.6
- value
- 2934
- group Id
- OG005
- spread
- 39.3
- value
- 3043
- comment
- Geometric coefficient of variation could not be calculated due to small number of participants.
- group Id
- OG006
- spread
- NA
- value
- 3500
- comment
- Geometric coefficient of variation could not be calculated due to small number of participants.
- group Id
- OG007
- spread
- NA
- value
- 3080
- denoms
- counts
- group Id
- OG000
- value
- 88
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 14
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- units
- Participants
- title
- Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 120
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- units
- Participants
- description
- Maximum Plasma Concentartion (Cmax) for FT-2102 is presented.
- dispersion Type
- Geometric Coefficient of Variation
- 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 150 mg BID (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 150 mg BID (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 150 mg BID (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 150 mg BID + 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 150 mg BID + 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 150 mg BID + 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 150 mg BID (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 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, Overall Number of Participants Analyzed (N) and number analyzed (n) = participants with available data for specific timepoints.
- reporting Status
- POSTED
- time Frame
- Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
- title
- Phase 2: Maximum Plasma Concentration (Cmax) for FT-2102
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice