TriangleNCT00932698 · OUTCOME
Maximum Tolerated Dose (MTD) of Ixazomib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/m^2
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1 (21 days)
What was measured
MTD was highest dose of Ixazomib, at which \<=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT was defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cell per cubic millimeter \[cells/mm\^3\]) for \>7 days;Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia (platelets \< 25,000/mm\^3) for \>7 days;Grade 3 thrombocytopenia with clinically significant bleeding; platelet count \<10,000/mm\^3; Grade 2 peripheral neuropathy with pain or \>=Grade 3 peripheral neuropathy; \>=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; Grade 3 QTc prolongation (QTc \>500 millisecond \[msec\]);any \>=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or \<1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by \>2 weeks; other \>=Grade 2 study drug-related nonhematologic toxicities requiring therapy discontinuation.
Analysis population: DLT-evaluable population was defined as all participants who received all Cycle 1 doses of ixazomib and completed Cycle 1 or who experienced DLT in Cycle 1.
Groups in this outcome
Ixazomib (All Groups)
All participants who received ixazomib 0.24 mg/m\^2, 0.48 mg/m\^2, 0.8 mg/m\^2, 1.2 mg/m\^2, 1.68 mg/m\^2, 2 mg/m\^2 or 2.23 mg/m\^2 in dose-escalation cohorts.
| Group | Source count |
|---|---|
| Ixazomib (All Groups) | 26 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib (All Groups) | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 26
- units
- Participants
- description
- MTD was highest dose of Ixazomib, at which \<=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT was defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cell per cubic millimeter \[cells/mm\^3\]) for \>7 days;Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia (platelets \< 25,000/mm\^3) for \>7 days;Grade 3 thrombocytopenia with clinically significant bleeding; platelet count \<10,000/mm\^3; Grade 2 peripheral neuropathy with pain or \>=Grade 3 peripheral neuropathy; \>=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; Grade 3 QTc prolongation (QTc \>500 millisecond \[msec\]);any \>=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or \<1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by \>2 weeks; other \>=Grade 2 study drug-related nonhematologic toxicities requiring therapy discontinuation.
- groups
- description
- All participants who received ixazomib 0.24 mg/m\^2, 0.48 mg/m\^2, 0.8 mg/m\^2, 1.2 mg/m\^2, 1.68 mg/m\^2, 2 mg/m\^2 or 2.23 mg/m\^2 in dose-escalation cohorts.
- id
- OG000
- title
- Ixazomib (All Groups)
- param Type
- NUMBER
- population Description
- DLT-evaluable population was defined as all participants who received all Cycle 1 doses of ixazomib and completed Cycle 1 or who experienced DLT in Cycle 1.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (21 days)
- title
- Maximum Tolerated Dose (MTD) of Ixazomib
- type
- PRIMARY
- unit Of Measure
- mg/m^2
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice