NCT04165031 · OUTCOME
Phase 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Baseline through Measured Progressive Disease (Up to 11 Months)
What was measured
DCR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed CR, confirmed PR, or SD out of all participants treatment. Best response is determined from a sequence of responses assessed. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. CR is defined as the disappearance of all targeted and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.
Analysis population: Zero participants were analyzed due to early termination of study.
Groups in this outcome
LY3499446 Phase 1 Cohort A1 (High Dose)
Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
LY3499446 Phase 1 Cohort AO (Mid Dose)
Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.
LY3499446 Phase 1 Cohort A-2 (Low Dose)
Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
| Group | Source count |
|---|---|
| LY3499446 Phase 1 Cohort A1 (High Dose) | 0 |
| LY3499446 Phase 1 Cohort AO (Mid Dose) | 0 |
| LY3499446 Phase 1 Cohort A-2 (Low Dose) | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- DCR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed CR, confirmed PR, or SD out of all participants treatment. Best response is determined from a sequence of responses assessed. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. CR is defined as the disappearance of all targeted and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.
- groups
- description
- Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
- id
- OG000
- title
- LY3499446 Phase 1 Cohort A1 (High Dose)
- description
- Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.
- id
- OG001
- title
- LY3499446 Phase 1 Cohort AO (Mid Dose)
- description
- Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
- id
- OG002
- title
- LY3499446 Phase 1 Cohort A-2 (Low Dose)
- population Description
- Zero participants were analyzed due to early termination of study.
- reporting Status
- POSTED
- time Frame
- Baseline through Measured Progressive Disease (Up to 11 Months)
- title
- Phase 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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