TriangleNCT03010358 · OUTCOME
Objective Response Rate (ORR)
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
- Up to 45 months
What was measured
Defined as percentage of participants with complete remission, complete response with incomplete marrow recovery, partial remission and nodular partial response. Response for CLL/SLL measured using Modified International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 (IWCLL) guidelines. Response for hairy cell leukemia was measured using Consensus resolution: proposed criteria published in Leukemia 1987.
Analysis population: Efficacy evaluable population: participants with CLL (Phase I/Phase II)
Groups in this outcome
All Research Participants
The Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol. Phase 1, Dose 1 received entospletinib at Dose Level 1: 400 mg daily (200 mg twice daily) in combination with obinutuzumab during Dose Escalation phase of study. Phase 1, Dose 2 received entospletinib at Dose Level 2: 800 mg daily (400 mg twice daily) in combination with obinutuzumab during Dose Escalation phase of study. Phase 2, MTD: Received entospletinib at Maximum Tolerated Dose (MTD) in combination with obinutuzumab during Dose Expansion phase of study. The MTD was determined to be 800 mg daily (400 mg twice daily).
| Group | Source count |
|---|---|
| All Research Participants | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Research Participants | 66.7 | Not reported | 43.0 | 85.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 43.0
- upper Limit
- 85.4
- value
- 66.7
- denoms
- counts
- group Id
- OG000
- value
- 21
- units
- Participants
- description
- Defined as percentage of participants with complete remission, complete response with incomplete marrow recovery, partial remission and nodular partial response. Response for CLL/SLL measured using Modified International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 (IWCLL) guidelines. Response for hairy cell leukemia was measured using Consensus resolution: proposed criteria published in Leukemia 1987.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- The Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol. Phase 1, Dose 1 received entospletinib at Dose Level 1: 400 mg daily (200 mg twice daily) in combination with obinutuzumab during Dose Escalation phase of study. Phase 1, Dose 2 received entospletinib at Dose Level 2: 800 mg daily (400 mg twice daily) in combination with obinutuzumab during Dose Escalation phase of study. Phase 2, MTD: Received entospletinib at Maximum Tolerated Dose (MTD) in combination with obinutuzumab during Dose Expansion phase of study. The MTD was determined to be 800 mg daily (400 mg twice daily).
- id
- OG000
- title
- All Research Participants
- param Type
- NUMBER
- population Description
- Efficacy evaluable population: participants with CLL (Phase I/Phase II)
- reporting Status
- POSTED
- time Frame
- Up to 45 months
- title
- Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice