TriangleNCT01832727 · OUTCOME
Percentage of Participants Who Achieved a Clinical Benefit Response As Assessed by Investigator During Phase 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Screening: Day 14 to Day -1; During study: Day 1 up to 13.16 months
What was measured
The clinical benefit rate (CBR) was defined as Overall Response Rate (ORR) plus Minimal Response (MR) as defined by the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Analysis population: Safety Population
Groups in this outcome
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 |
|---|---|
| Phase 2 300 mg 2/7 Schedule | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 300 mg 2/7 Schedule | 72.2 | Not reported | 46.5 | 90.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 46.5
- upper Limit
- 90.3
- value
- 72.2
- denoms
- counts
- group Id
- OG000
- value
- 18
- units
- Participants
- description
- The clinical benefit rate (CBR) was defined as Overall Response Rate (ORR) plus Minimal Response (MR) as defined by the European Group for Blood and Marrow Transplantation (EBMT) criteria.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- title
- Phase 2 300 mg 2/7 Schedule
- param Type
- NUMBER
- population Description
- Safety Population
- reporting Status
- POSTED
- time Frame
- Screening: Day 14 to Day -1; During study: Day 1 up to 13.16 months
- title
- Percentage of Participants Who Achieved a Clinical Benefit Response As Assessed by Investigator During Phase 2
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice