TriangleNCT02530476 · OUTCOME
Composite CR (CRc) Rate Defined as CR (Complete Remission) + CRp (Complete Remission With Incomplete Platelet Recovery) + CRi (Complete Remission With Incomplete Count Recovery) Within 3 Months of Treatment Initiation
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 84 days, assessed following first three cycles of therapy of Selinexor with Sorafenib
What was measured
CRc Response criteria modified from International Working Group for AML. Responders obtain a Composite Complete Remission Rate (CRc) with or without cytogenetic response, hematologic improvements, and morphologic leukemia-free state. CRc rate is defined as the confirmed remission rate of all complete and incomplete CRs (i.e., CR+ CRp + CRi). CR: bone marrow regenerating normal hematopoietic cells \& morphologic leukemia-free state, \& ANC \> 1×10\^9/L, platelet count ≥100×10\^9/L, \& normal marrow differential with \<5% blasts, \& red blood cell (RBC) and platelet transfusion independent, no evidence of extramedullary leukemia. CRp: CR except for incomplete platelet recovery (\<100×10\^9/L). CRi: Same criteria for CR except incomplete hematological recovery with residual neutropenia (ANC ≤ 1 × 109/L) with or without thrombocytopenia (platelet count \<100×109/L). No need to be RBC or platelet transfusion independent (modification to Cheson criteria).
Analysis population: Of the four participants in the Phase I Group 1 Selinexor + Sorafenib arm, one participant was not evaluable for response. Of the seven participants in cohort 1, one participant was not evaluable for response. Of the three participants in cohort 2, one participant was not evaluable for response.
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 | 3 |
| Phase I Group 2 Selinexor + Sorafenib | 3 |
| Cohort 1 (FLT3-ITD Inhibitor Failure Cohort) | 6 |
| Cohort 2 (FLT3-ITD Inhibitor Naive Cohort) | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Group 1 Selinexor + Sorafenib | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase I Group 2 Selinexor + Sorafenib | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 (FLT3-ITD Inhibitor Failure Cohort) | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 (FLT3-ITD Inhibitor Naive Cohort) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 2
- units
- Participants
- description
- CRc Response criteria modified from International Working Group for AML. Responders obtain a Composite Complete Remission Rate (CRc) with or without cytogenetic response, hematologic improvements, and morphologic leukemia-free state. CRc rate is defined as the confirmed remission rate of all complete and incomplete CRs (i.e., CR+ CRp + CRi). CR: bone marrow regenerating normal hematopoietic cells \& morphologic leukemia-free state, \& ANC \> 1×10\^9/L, platelet count ≥100×10\^9/L, \& normal marrow differential with \<5% blasts, \& red blood cell (RBC) and platelet transfusion independent, no evidence of extramedullary leukemia. CRp: CR except for incomplete platelet recovery (\<100×10\^9/L). CRi: Same criteria for CR except incomplete hematological recovery with residual neutropenia (ANC ≤ 1 × 109/L) with or without thrombocytopenia (platelet count \<100×109/L). No need to be RBC or platelet transfusion independent (modification to Cheson criteria).
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Of the four participants in the Phase I Group 1 Selinexor + Sorafenib arm, one participant was not evaluable for response. Of the seven participants in cohort 1, one participant was not evaluable for response. Of the three participants in cohort 2, one participant was not evaluable for response.
- reporting Status
- POSTED
- time Frame
- 84 days, assessed following first three cycles of therapy of Selinexor with Sorafenib
- title
- Composite CR (CRc) Rate Defined as CR (Complete Remission) + CRp (Complete Remission With Incomplete Platelet Recovery) + CRi (Complete Remission With Incomplete Count Recovery) Within 3 Months of Treatment Initiation
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice