TriangleNCT01832727 · OUTCOME
Participants With Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2
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 up to Week 282
What was measured
AE defined as any untoward medical occurrence in a clinical trial participant. Treatment-emergent adverse events were defined as adverse events that start on or after the first day of study treatment and within 30 days of the last day of study treatment. An adverse event that was present before the first administration of study treatment and subsequently worsens in severity during treatment was also considered to be treatment-emergent. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE, v4.03) based on the general guideline: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to AE. IP=investigational product
Analysis population: Safety population
Groups in this outcome
Cohort 180 mg 5/14 Schedule (Phase 1b)
Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
Cohort 210 mg 5/14 Schedule (Phase 1b)
Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
Cohort 150/180 mg 5/14 Schedule (Phase 1b)
Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
Cohort 210 mg 2/7 Schedule (Phase 1b)
Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
Cohort 240 mg 2/7 Schedule (Phase 1b)
Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
Cohort 270 mg 2/7 Schedule (Phase 1b)
Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
Cohort 300 mg 2/7 Schedule (Phase 1b)
Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
Cohort 330 mg 2/7 Schedule (Phase 1b)
Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
| Group | Source count |
|---|---|
| Cohort 180 mg 5/14 Schedule (Phase 1b) | 9 |
| Cohort 210 mg 5/14 Schedule (Phase 1b) | 7 |
| Cohort 150/180 mg 5/14 Schedule (Phase 1b) | 3 |
| Cohort 210 mg 2/7 Schedule (Phase 1b) | 4 |
| Cohort 240 mg 2/7 Schedule (Phase 1b) | 4 |
| Cohort 270 mg 2/7 Schedule (Phase 1b) | 6 |
| Cohort 300 mg 2/7 Schedule (Phase 1b) | 8 |
| Cohort 330 mg 2/7 Schedule (Phase 1b) | 6 |
| Phase 2 300 mg 2/7 Schedule | 18 |
Reported measurements
>=1 TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 180 mg 5/14 Schedule (Phase 1b) | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 210 mg 5/14 Schedule (Phase 1b) | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 150/180 mg 5/14 Schedule (Phase 1b) | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 210 mg 2/7 Schedule (Phase 1b) | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 240 mg 2/7 Schedule (Phase 1b) | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 270 mg 2/7 Schedule (Phase 1b) | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 300 mg 2/7 Schedule (Phase 1b) | 8 | Not reported | Not reported | Not reported | Not reported |
| Cohort 330 mg 2/7 Schedule (Phase 1b) | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 300 mg 2/7 Schedule | 18 | Not reported | Not reported | Not reported | Not reported |
Grade >=3 (severe)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 180 mg 5/14 Schedule (Phase 1b) | 8 | Not reported | Not reported | Not reported | Not reported |
| Cohort 210 mg 5/14 Schedule (Phase 1b) | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 150/180 mg 5/14 Schedule (Phase 1b) | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 210 mg 2/7 Schedule (Phase 1b) | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 240 mg 2/7 Schedule (Phase 1b) | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 270 mg 2/7 Schedule (Phase 1b) | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 300 mg 2/7 Schedule (Phase 1b) | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 330 mg 2/7 Schedule (Phase 1b) | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 300 mg 2/7 Schedule | 16 | Not reported | Not reported | Not reported | Not reported |
Serious AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 180 mg 5/14 Schedule (Phase 1b) | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 210 mg 5/14 Schedule (Phase 1b) | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 150/180 mg 5/14 Schedule (Phase 1b) | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 210 mg 2/7 Schedule (Phase 1b) | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 240 mg 2/7 Schedule (Phase 1b) | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 270 mg 2/7 Schedule (Phase 1b) | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 300 mg 2/7 Schedule (Phase 1b) | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 330 mg 2/7 Schedule (Phase 1b) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 300 mg 2/7 Schedule | 9 | Not reported | Not reported | Not reported | Not reported |
Leading to discontinuation of IP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 180 mg 5/14 Schedule (Phase 1b) | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 210 mg 5/14 Schedule (Phase 1b) | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 150/180 mg 5/14 Schedule (Phase 1b) | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 210 mg 2/7 Schedule (Phase 1b) | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 240 mg 2/7 Schedule (Phase 1b) | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 270 mg 2/7 Schedule (Phase 1b) | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 300 mg 2/7 Schedule (Phase 1b) | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 330 mg 2/7 Schedule (Phase 1b) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 300 mg 2/7 Schedule | 11 | Not reported | Not reported | Not reported | Not reported |
Fatal AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 180 mg 5/14 Schedule (Phase 1b) | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 210 mg 5/14 Schedule (Phase 1b) | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 150/180 mg 5/14 Schedule (Phase 1b) | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 210 mg 2/7 Schedule (Phase 1b) | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 240 mg 2/7 Schedule (Phase 1b) | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 270 mg 2/7 Schedule (Phase 1b) | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 300 mg 2/7 Schedule (Phase 1b) | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 330 mg 2/7 Schedule (Phase 1b) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 300 mg 2/7 Schedule | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 18
- title
- >=1 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 16
- title
- Grade >=3 (severe)
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 9
- title
- Serious AE
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 11
- title
- Leading to discontinuation of IP
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Fatal AE
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 18
- units
- Participants
- description
- AE defined as any untoward medical occurrence in a clinical trial participant. Treatment-emergent adverse events were defined as adverse events that start on or after the first day of study treatment and within 30 days of the last day of study treatment. An adverse event that was present before the first administration of study treatment and subsequently worsens in severity during treatment was also considered to be treatment-emergent. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE, v4.03) based on the general guideline: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to AE. IP=investigational product
- groups
- description
- Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
- id
- OG000
- title
- Cohort 180 mg 5/14 Schedule (Phase 1b)
- description
- Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
- id
- OG001
- title
- Cohort 210 mg 5/14 Schedule (Phase 1b)
- description
- Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
- id
- OG002
- title
- Cohort 150/180 mg 5/14 Schedule (Phase 1b)
- description
- Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
- id
- OG003
- title
- Cohort 210 mg 2/7 Schedule (Phase 1b)
- description
- Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
- id
- OG004
- title
- Cohort 240 mg 2/7 Schedule (Phase 1b)
- description
- Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
- id
- OG005
- title
- Cohort 270 mg 2/7 Schedule (Phase 1b)
- description
- Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
- id
- OG006
- title
- Cohort 300 mg 2/7 Schedule (Phase 1b)
- description
- Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
- id
- OG007
- title
- Cohort 330 mg 2/7 Schedule (Phase 1b)
- description
- The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
- id
- OG008
- title
- Phase 2 300 mg 2/7 Schedule
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- Day 1 up to Week 282
- title
- Participants With Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice