TriangleNCT02530476 · OUTCOME
Maximum Tolerated Dose (MTD) of Selinexor With Sorafenib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Milligrams
- Interval / dispersion
- Not reported
- Time frame
- 28 days
What was measured
MTD defined as the highest dose level with \</= 1 out of 6 patients experience a dose limiting toxicity (DLT) during the first 28 days of treatment.
Analysis population: The Outcome Measure of MTD was the objective of the Phase I Selinexor + Sorafenib cohort only. Data for MTD were not collected for patients on Cohorts 1 and 2.
Groups in this outcome
Phase I Group 1 Selinexor + Sorafenib
Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
Phase I Group 2 Selinexor + Sorafenib
Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase I Group 2 received Selinexor 80 mg by mouth twice weekly for a 28 day cycle.
Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)
Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)
Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
| Group | Source count |
|---|---|
| Phase I Group 1 Selinexor + Sorafenib | 4 |
| Phase I Group 2 Selinexor + Sorafenib | 3 |
| Cohort 1 (FLT3-ITD Inhibitor Failure Cohort) | 0 |
| Cohort 2 (FLT3-ITD Inhibitor Naive Cohort) | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Group 1 Selinexor + Sorafenib | 60 | Not reported | Not reported | Not reported | Not reported |
| Phase I Group 2 Selinexor + Sorafenib | 60 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 60
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- MTD defined as the highest dose level with \</= 1 out of 6 patients experience a dose limiting toxicity (DLT) during the first 28 days of treatment.
- groups
- description
- Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
- id
- OG000
- title
- Phase I Group 1 Selinexor + Sorafenib
- description
- Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase I Group 2 received Selinexor 80 mg by mouth twice weekly for a 28 day cycle.
- id
- OG001
- title
- Phase I Group 2 Selinexor + Sorafenib
- description
- Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
- id
- OG002
- title
- Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)
- description
- Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
- id
- OG003
- title
- Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)
- param Type
- NUMBER
- population Description
- The Outcome Measure of MTD was the objective of the Phase I Selinexor + Sorafenib cohort only. Data for MTD were not collected for patients on Cohorts 1 and 2.
- reporting Status
- POSTED
- time Frame
- 28 days
- title
- Maximum Tolerated Dose (MTD) of Selinexor With Sorafenib
- type
- PRIMARY
- unit Of Measure
- Milligrams
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice