TriangleNCT02939183 · OUTCOME
Maximum Tolerated Dose (MTD) of Each Formulation of Oprozomib in Combination With Pomolidomide and Dexamethasone
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/day
- Interval / dispersion
- Not reported
- Time frame
- Day 1 to Day 28 of cycle 1, where each cycle was 28 days
What was measured
The MTD was the dose with the highest posterior probability of having a DLT rate within the target toxicity interval (15% to 25%), while the posterior probability of excessive/unacceptable toxicity (\>25% to 100%) is \<40%. DLTs were graded using CTCAE version 4.03 and included the below, if judged by the investigator/medical monitor to be possibly related to study treatment: Non-hematologic DLTs were any ≥ Grade 3 toxicity, except: Grade 3 asymptomatic electrolyte abnormalities (except hypophosphatemia \> 24 hours); Grade 3 nausea, vomiting and diarrhea \< 3 days; Grade 3 fatigue \< 14 days; ≥ Grade 3 hyperglycemia/toxicity due to dexamethasone; ≥ Grade 3 rash due to pomalidomide. Hematologic DLTs included: Grade 4 neutropenia if absolute neutrophil count \< 0.5 x 10\^9/L ≥ 7 days; febrile neutropenia; Grade 4 thrombocytopenia ≥ 7 days; Grade ≥ 3 with ≥ Grade 2 bleeding/requiring platelet transfusion.
Analysis population: DLT-evaluable participants in Part 2 who received the following during the 28-day DLT window: all planned doses of oprozomib, a minimum of 17 of 21 planned doses of pomalidomide, and a minimum of 6 of 8 planned doses of dexamethasone.
Groups in this outcome
All Doses Oprozomib IR + Pomalidomide + Dexamethasone
Participants who received oprozomib IR in a 2/7 schedule in combination with pomalidomide and dexamethasone in Part 2. Doses of oprozomib IR administered were 150 mg/day (N=4), 200 mg/day (N=8), 225 mg/day (N=10), and 250 mg/day (N=8).
All Doses Oprozomib GR + Pomalidomide + Dexamethasone
Participants who received oprozomib GR in a 2/7 schedule in combination with pomalidomide and dexamethasone in Part 2. Doses of oprozomib GR administered were 150 mg/day (N=4), and 200 mg/day (N=5).
| Group | Source count |
|---|---|
| All Doses Oprozomib IR + Pomalidomide + Dexamethasone | 30 |
| All Doses Oprozomib GR + Pomalidomide + Dexamethasone | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Doses Oprozomib IR + Pomalidomide + Dexamethasone | 250 | Not reported | Not reported | Not reported | Not reported |
| All Doses Oprozomib GR + Pomalidomide + Dexamethasone | NA | Not reported | Not reported | Not reported | The MTD for oprozomib GR in combination with pomalidomide and dexamethasone was not determined due to too few DLTs. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 250
- comment
- The MTD for oprozomib GR in combination with pomalidomide and dexamethasone was not determined due to too few DLTs.
- group Id
- OG001
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- The MTD was the dose with the highest posterior probability of having a DLT rate within the target toxicity interval (15% to 25%), while the posterior probability of excessive/unacceptable toxicity (\>25% to 100%) is \<40%. DLTs were graded using CTCAE version 4.03 and included the below, if judged by the investigator/medical monitor to be possibly related to study treatment: Non-hematologic DLTs were any ≥ Grade 3 toxicity, except: Grade 3 asymptomatic electrolyte abnormalities (except hypophosphatemia \> 24 hours); Grade 3 nausea, vomiting and diarrhea \< 3 days; Grade 3 fatigue \< 14 days; ≥ Grade 3 hyperglycemia/toxicity due to dexamethasone; ≥ Grade 3 rash due to pomalidomide. Hematologic DLTs included: Grade 4 neutropenia if absolute neutrophil count \< 0.5 x 10\^9/L ≥ 7 days; febrile neutropenia; Grade 4 thrombocytopenia ≥ 7 days; Grade ≥ 3 with ≥ Grade 2 bleeding/requiring platelet transfusion.
- groups
- description
- Participants who received oprozomib IR in a 2/7 schedule in combination with pomalidomide and dexamethasone in Part 2. Doses of oprozomib IR administered were 150 mg/day (N=4), 200 mg/day (N=8), 225 mg/day (N=10), and 250 mg/day (N=8).
- id
- OG000
- title
- All Doses Oprozomib IR + Pomalidomide + Dexamethasone
- description
- Participants who received oprozomib GR in a 2/7 schedule in combination with pomalidomide and dexamethasone in Part 2. Doses of oprozomib GR administered were 150 mg/day (N=4), and 200 mg/day (N=5).
- id
- OG001
- title
- All Doses Oprozomib GR + Pomalidomide + Dexamethasone
- param Type
- NUMBER
- population Description
- DLT-evaluable participants in Part 2 who received the following during the 28-day DLT window: all planned doses of oprozomib, a minimum of 17 of 21 planned doses of pomalidomide, and a minimum of 6 of 8 planned doses of dexamethasone.
- reporting Status
- POSTED
- time Frame
- Day 1 to Day 28 of cycle 1, where each cycle was 28 days
- title
- Maximum Tolerated Dose (MTD) of Each Formulation of Oprozomib in Combination With Pomolidomide and Dexamethasone
- type
- PRIMARY
- unit Of Measure
- mg/day
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice