TriangleNCT01607892 · OUTCOME
Recommended Phase 2 Dose (RP2D) of Selinexor
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- milligram per square meter (mg/m^2)
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study drug administration to end of treatment (up to 27 months)
What was measured
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD was defined as the next lower dose level below the one in which \> 1 of 3 participants or ≥ 2 of 6 participants experienced dose-limiting toxicity (DLT), provided that that dose level is ≤25% lower than the highest dose tested. If the projected MTD was \>25% lower than the highest dose tested, then an additional cohort of ≥3 participants were added at a dose that was intermediate between the intolerable dose and the next lower dose.
Analysis population: Efficacy analysis set included all participants who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented progressive disease (PD), death related to disease, or treatment-related toxicity. Here, data was not planned and analyzed based on individual specific disease, hence overall data was analyzed for this outcome measure.
Groups in this outcome
Advanced Hematological Malignancies.
Participants received selinexor doses of \<= 12 mg/m\^2, post oral for all cycles 3 times weekly for Weeks 1 and 3 in schedule 1; \>12 mg/m\^2 3 times weekly for Weeks 2 and 4 in schedule 2; \>=30 mg/m\^2 on Day 1 and 3 in schedule 3; \>= 23 mg/m\^2 on Day 1 and Day 2 for a 28-day cycle in schedule 4; \>= 30 mg/m\^2 on Day 1 and 4 in schedule 5; \>= 35 mg/m\^2 combined with dexamethasone 20 mg on Day 1 and 3 in schedule 6; \>= 45 mg/m\^2 once-weekly in schedule 7; \>= 40 mg/m\^2 twice-weekly for first 2 weeks on Days 1, 3, 8, and 10 followed by an 11-day treatment-free interval in schedule 8; \>= 30 mg/m\^2 twice weekly for 3 weeks in 28-day cycle followed by fixed dose of 375 mg/m\^2 Rituximab in schedule 9; 55 mg/m\^2 twice-weekly on Days 1, 3, 8, and 10 followed by 18-day treatment-free interval in schedule 10; 40, 60, 80 mg (group A, group B, group C) twice weekly during the first 3 weeks, on Days 1, 3, 8, 10, 15 and 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
| Group | Source count |
|---|---|
| Advanced Hematological Malignancies. | 285 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Advanced Hematological Malignancies. | 35 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 35
- denoms
- counts
- group Id
- OG000
- value
- 285
- units
- Participants
- description
- Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD was defined as the next lower dose level below the one in which \> 1 of 3 participants or ≥ 2 of 6 participants experienced dose-limiting toxicity (DLT), provided that that dose level is ≤25% lower than the highest dose tested. If the projected MTD was \>25% lower than the highest dose tested, then an additional cohort of ≥3 participants were added at a dose that was intermediate between the intolerable dose and the next lower dose.
- groups
- description
- Participants received selinexor doses of \<= 12 mg/m\^2, post oral for all cycles 3 times weekly for Weeks 1 and 3 in schedule 1; \>12 mg/m\^2 3 times weekly for Weeks 2 and 4 in schedule 2; \>=30 mg/m\^2 on Day 1 and 3 in schedule 3; \>= 23 mg/m\^2 on Day 1 and Day 2 for a 28-day cycle in schedule 4; \>= 30 mg/m\^2 on Day 1 and 4 in schedule 5; \>= 35 mg/m\^2 combined with dexamethasone 20 mg on Day 1 and 3 in schedule 6; \>= 45 mg/m\^2 once-weekly in schedule 7; \>= 40 mg/m\^2 twice-weekly for first 2 weeks on Days 1, 3, 8, and 10 followed by an 11-day treatment-free interval in schedule 8; \>= 30 mg/m\^2 twice weekly for 3 weeks in 28-day cycle followed by fixed dose of 375 mg/m\^2 Rituximab in schedule 9; 55 mg/m\^2 twice-weekly on Days 1, 3, 8, and 10 followed by 18-day treatment-free interval in schedule 10; 40, 60, 80 mg (group A, group B, group C) twice weekly during the first 3 weeks, on Days 1, 3, 8, 10, 15 and 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
- id
- OG000
- title
- Advanced Hematological Malignancies.
- param Type
- NUMBER
- population Description
- Efficacy analysis set included all participants who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented progressive disease (PD), death related to disease, or treatment-related toxicity. Here, data was not planned and analyzed based on individual specific disease, hence overall data was analyzed for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug administration to end of treatment (up to 27 months)
- title
- Recommended Phase 2 Dose (RP2D) of Selinexor
- type
- PRIMARY
- unit Of Measure
- milligram per square meter (mg/m^2)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice