TriangleNCT02939183 · OUTCOME
Number of Participants Who Experienced Dose-Limiting Toxcity (DLT)
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
- Day 1 to day 28 of cycle 1, where each cycle was 28 days
What was measured
DLTs were graded using the Common Terminology Criteria for Adverse Events (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 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. One participant enrolled in arm Oprozomib IR 200 mg/day + pomalidomide + dexamethasone received oprozomib IR 150 mg + pomalidomide + dexamethasone, and this participant was included in the Oprozomib IR 150 mg + pomalidomide + dexamethasone arm.
Groups in this outcome
Oprozomib IR 150 mg/Day + Dexamethsone
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
Oprozomib GR 150 mg/Day + Dexamethasone
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
| Group | Source count |
|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 5 |
| Oprozomib GR 150 mg/Day + Dexamethasone | 8 |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 4 |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 4 |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 8 |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 5 |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 10 |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 8
- units
- Participants
- description
- DLTs were graded using the Common Terminology Criteria for Adverse Events (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
- In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
- id
- OG000
- title
- Oprozomib IR 150 mg/Day + Dexamethsone
- description
- In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
- id
- OG001
- title
- Oprozomib GR 150 mg/Day + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG002
- title
- Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG003
- title
- Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG004
- title
- Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG005
- title
- Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG006
- title
- Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG007
- title
- Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- DLT-evaluable participants 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. One participant enrolled in arm Oprozomib IR 200 mg/day + pomalidomide + dexamethasone received oprozomib IR 150 mg + pomalidomide + dexamethasone, and this participant was included in the Oprozomib IR 150 mg + pomalidomide + dexamethasone arm.
- reporting Status
- POSTED
- time Frame
- Day 1 to day 28 of cycle 1, where each cycle was 28 days
- title
- Number of Participants Who Experienced Dose-Limiting Toxcity (DLT)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice