TriangleNCT01832727 · OUTCOME
Participants With Dose-Limiting Toxicities (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 14 (Cycle 1) for continous dosing and Day 15 to Day 28 (Cycle 2) for step-up dosing
What was measured
Toxicities (graded per the Common Terminology Criteria for Adverse Events v 4.03) were considered DLTs if judged by the investigator to be related to oprozomib and occurred in the first 14 days of treatment, with treatment at the dose to be studied (i.e., Cycle 1 for continuous dosing or Cycle 2 for step-up dosing). A DLT was categorized as nonhematologic or hematologic. Examples include: * Any ≥ Grade 3 nonhematologic AE, with exceptions or qualifications such as Grade 3 nausea, vomiting, diarrhea, or constipation were considered a DLT only if lasting for \> 7 days despite optimal supportive care * Grade 3 fatigue lasting \> 14 days * Grade 4 neutropenia: absolute neutrophil count (ANC) \< 500 cells/mcL lasting ≥ 7 days * Febrile neutropenia: Any single temperature ≥ 38.3°C or a sustained temperature of ≥ 38.0°C for over 1 hour with ≥ Grade 3 neutropenia (ANC \< 1000 cells/mcL) * Grade 3/4 thrombocytopenia * Others specified in the protocol
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
Participants reporting >=1 DLT
| 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) | 3 | 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 270 mg 2/7 Schedule (Phase 1b) | 2 | 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) | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 300 mg 2/7 Schedule | 1 | Not reported | Not reported | Not reported | Not reported |
Mental status changes
| 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) | 0 | 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) | 0 | 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 |
Alanine aminotransferase increased
| 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) | 0 | 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 |
Aspartate aminotransferase increased
| 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) | 0 | 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 |
Hypertension
| 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) | 0 | 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 |
Subarachnoid haemorrhage
| 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) | 0 | 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 |
Thrombocytopenia
| 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) | 0 | 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) | 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 |
Anemia
| 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) | 0 | 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) | 0 | 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 | 1 | Not reported | Not reported | Not reported | Not reported |
Nausea
| 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) | 0 | 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) | 0 | 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) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 300 mg 2/7 Schedule | 0 | Not reported | Not reported | Not reported | Not reported |
Upper respiratory tract infection
| 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) | 0 | 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) | 0 | 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) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 300 mg 2/7 Schedule | 0 | Not reported | Not reported | Not reported | Not reported |
Vomiting
| 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) | 0 | 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) | 0 | 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) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 300 mg 2/7 Schedule | 0 | Not reported | Not reported | Not reported | Not reported |
Pain in jaw
| 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) | 0 | 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) | 0 | 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) | 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
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 1
- title
- Participants reporting >=1 DLT
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Mental status changes
- 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
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Alanine aminotransferase increased
- 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
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Aspartate aminotransferase increased
- 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
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Hypertension
- 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
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Subarachnoid haemorrhage
- 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
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Thrombocytopenia
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- title
- Anemia
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- title
- Nausea
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- title
- Upper respiratory tract infection
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- title
- Vomiting
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Pain in jaw
- 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
- Toxicities (graded per the Common Terminology Criteria for Adverse Events v 4.03) were considered DLTs if judged by the investigator to be related to oprozomib and occurred in the first 14 days of treatment, with treatment at the dose to be studied (i.e., Cycle 1 for continuous dosing or Cycle 2 for step-up dosing). A DLT was categorized as nonhematologic or hematologic. Examples include: * Any ≥ Grade 3 nonhematologic AE, with exceptions or qualifications such as Grade 3 nausea, vomiting, diarrhea, or constipation were considered a DLT only if lasting for \> 7 days despite optimal supportive care * Grade 3 fatigue lasting \> 14 days * Grade 4 neutropenia: absolute neutrophil count (ANC) \< 500 cells/mcL lasting ≥ 7 days * Febrile neutropenia: Any single temperature ≥ 38.3°C or a sustained temperature of ≥ 38.0°C for over 1 hour with ≥ Grade 3 neutropenia (ANC \< 1000 cells/mcL) * Grade 3/4 thrombocytopenia * Others specified in the protocol
- 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 to Day 14 (Cycle 1) for continous dosing and Day 15 to Day 28 (Cycle 2) for step-up dosing
- title
- Participants With Dose-Limiting Toxicities (DLT)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice