TriangleNCT02719574 · OUTCOME
Phase 2: 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
- h*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
Area under the plasma concentration-time curve from zero time until the last measurable concentration 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) | 117 |
| 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) | 12 |
| 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) | 117 |
| 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) | 12 |
| 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) | 2836 | 59.5 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 2; FT-2102 150 mg BID (Single Agent) | 2657 | 36.8 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 3; FT-2102 150 mg BID (Single Agent) | 1880 | 77.4 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 4; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 3051 | 109.7 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 5; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 2031 | 69.4 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 6; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 1701 | 39.4 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 7; FT-2102 150 mg BID (Single Agent) | 4165 | 116.5 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 8; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 3898 | 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) | 20610 | 69.7 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 2; FT-2102 150 mg BID (Single Agent) | 27710 | 14.9 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 4; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 19820 | 77.6 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 5; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 19610 | 62.1 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 6; FT-2102 150 mg BID + Azacitidine (Combination Therapy) | 21810 | 45.6 | Not reported | Not reported | Not reported |
| Phase 2: Cohort 7; FT-2102 150 mg BID (Single Agent) | 25880 | 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) | 19940 | 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
- 59.5
- value
- 2836
- group Id
- OG001
- spread
- 36.8
- value
- 2657
- group Id
- OG002
- spread
- 77.4
- value
- 1880
- group Id
- OG003
- spread
- 109.7
- value
- 3051
- group Id
- OG004
- spread
- 69.4
- value
- 2031
- group Id
- OG005
- spread
- 39.4
- value
- 1701
- group Id
- OG006
- spread
- 116.5
- value
- 4165
- comment
- Geometric coefficient of variation could not be calculated due to small number of participants.
- group Id
- OG007
- spread
- NA
- value
- 3898
- denoms
- counts
- group Id
- OG000
- value
- 117
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 12
- 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
- 69.7
- value
- 20610
- group Id
- OG001
- spread
- 14.9
- value
- 27710
- group Id
- OG003
- spread
- 77.6
- value
- 19820
- group Id
- OG004
- spread
- 62.1
- value
- 19610
- group Id
- OG005
- spread
- 45.6
- value
- 21810
- comment
- Geometric coefficient of variation could not be calculated due to small number of participants.
- group Id
- OG006
- spread
- NA
- value
- 25880
- comment
- Geometric coefficient of variation could not be calculated due to small number of participants.
- group Id
- OG007
- spread
- NA
- value
- 19940
- 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
- 117
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- 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 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: Area Under the Curve (AUClast) for FT-2102
- type
- SECONDARY
- unit Of Measure
- h*ng/mL
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Preserved source evidence · Not medical advice