TriangleNCT02719574 · OUTCOME
Phase 2: Time to Response (TTR) for Acute Myeloid Leukemia (AML)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
What was measured
TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
Analysis population: FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. Here, Overall Number of Participants Analyzed = participants with PR or better as a best overall response. Data is reported only for Cohort 1, 3, 4, 5, 6, 7 and 8.
Groups in this outcome
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Phase 2: Cohort 3; FT-2102 (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 + 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 + 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 + 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 (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 + 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 (Single Agent) | 75 |
| Phase 2: Cohort 3; FT-2102 (Single Agent) | 0 |
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 13 |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 6 |
| Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) | 8 |
| Phase 2: Cohort 7; FT-2102 (Single Agent) | 5 |
| Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 1; FT-2102 (Single Agent) | 1.90 | Not reported | 0.9 | 10.2 | Not reported |
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 1.80 | Not reported | 0.9 | 3.8 | Not reported |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 2.50 | Not reported | 1.0 | 4.2 | Not reported |
| Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) | 2.50 | Not reported | 1.0 | 7.6 | Not reported |
| Phase 2: Cohort 7; FT-2102 (Single Agent) | 1.90 | Not reported | 1.8 | 3.9 | Not reported |
| Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) | 2.80 | Not reported | 1.1 | 5.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.9
- upper Limit
- 10.2
- value
- 1.90
- group Id
- OG002
- lower Limit
- 0.9
- upper Limit
- 3.8
- value
- 1.80
- group Id
- OG003
- lower Limit
- 1.0
- upper Limit
- 4.2
- value
- 2.50
- group Id
- OG004
- lower Limit
- 1.0
- upper Limit
- 7.6
- value
- 2.50
- group Id
- OG005
- lower Limit
- 1.8
- upper Limit
- 3.9
- value
- 1.90
- group Id
- OG006
- lower Limit
- 1.1
- upper Limit
- 5.6
- value
- 2.80
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 7
- units
- Participants
- description
- TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
- dispersion Type
- Full Range
- 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 (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
- OG001
- title
- Phase 2: Cohort 3; FT-2102 (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
- OG002
- title
- Phase 2: Cohort 4; FT-2102 + 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
- OG003
- title
- Phase 2: Cohort 5; FT-2102 + 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
- OG004
- title
- Phase 2: Cohort 6; FT-2102 + 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
- OG005
- title
- Phase 2: Cohort 7; FT-2102 (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
- OG006
- title
- Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
- param Type
- MEDIAN
- population Description
- FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. Here, Overall Number of Participants Analyzed = participants with PR or better as a best overall response. Data is reported only for Cohort 1, 3, 4, 5, 6, 7 and 8.
- reporting Status
- POSTED
- time Frame
- Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
- title
- Phase 2: Time to Response (TTR) for Acute Myeloid Leukemia (AML)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice