TriangleNCT01318902 · 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
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1 (28 days)
What was measured
MTD was highest dose of Ixazomib, at which \<=1 of 6 participants experienced dose-limiting toxicity (DLT). DLT was defined using National Cancer Institute Common Terminology Criteria for Adverse Events, v 4.03 as: Grade 4 neutropenia (absolute neutrophil count \<500 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 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, considered possibly related to therapy as assessed by Investigator.
Analysis population: DLT-evaluable population included all participants who received all Cycle 1 doses of ixazomib or experienced a DLT in Cycle 1.
Groups in this outcome
Dose Escalation Cohort: Ixazomib 4.0 mg
Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
Dose Escalation Cohort: Ixazomib 5.5 mg
Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
| Group | Source count |
|---|---|
| Dose Escalation Cohort: Ixazomib 4.0 mg | 6 |
| Dose Escalation Cohort: Ixazomib 5.5 mg | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Ixazomib 4.0 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Ixazomib 5.5 mg | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- MTD was highest dose of Ixazomib, at which \<=1 of 6 participants experienced dose-limiting toxicity (DLT). DLT was defined using National Cancer Institute Common Terminology Criteria for Adverse Events, v 4.03 as: Grade 4 neutropenia (absolute neutrophil count \<500 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 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, considered possibly related to therapy as assessed by Investigator.
- groups
- description
- Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
- id
- OG000
- title
- Dose Escalation Cohort: Ixazomib 4.0 mg
- description
- Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.
- id
- OG001
- title
- Dose Escalation Cohort: Ixazomib 5.5 mg
- param Type
- NUMBER
- population Description
- DLT-evaluable population included all participants who received all Cycle 1 doses of ixazomib or experienced a DLT in Cycle 1.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (28 days)
- title
- Maximum Tolerated Dose (MTD) of Ixazomib
- type
- PRIMARY
- unit Of Measure
- mg
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice