NCT06039384 · OUTCOME
Objective Response
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 470 days
What was measured
Objective response was defined as having a best overall response of complete response (CR) or partial response (PR) assessed per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Analysis population: Full Analysis Set: all participants who received at least 1 dose of INCB099280 or adagrasib. Participants were analyzed according to the treatment to which they were assigned. Confidence intervals were calculated using the Clopper-Pearson method.
Groups in this outcome
INCB099280 50 mg QD Plus Adagrasib 400 mg BID
Participants received INCB099280 50 milligrams (mg) once daily (QD) plus adagrasib 400 mg twice daily (BID) for up to 2 years.
INCB099280 100 mg BID Plus Adagrasib 400 mg BID
Participants received INCB099280 100 mg BID plus adagrasib 400 mg BID for up to 2 years.
| Group | Source count |
|---|---|
| INCB099280 50 mg QD Plus Adagrasib 400 mg BID | 3 |
| INCB099280 100 mg BID Plus Adagrasib 400 mg BID | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| INCB099280 50 mg QD Plus Adagrasib 400 mg BID | 66.7 | Not reported | 9.4 | 99.2 | Not reported |
| INCB099280 100 mg BID Plus Adagrasib 400 mg BID | 0.0 | Not reported | 0.0 | 70.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.4
- upper Limit
- 99.2
- value
- 66.7
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 70.8
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Objective response was defined as having a best overall response of complete response (CR) or partial response (PR) assessed per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received INCB099280 50 milligrams (mg) once daily (QD) plus adagrasib 400 mg twice daily (BID) for up to 2 years.
- id
- OG000
- title
- INCB099280 50 mg QD Plus Adagrasib 400 mg BID
- description
- Participants received INCB099280 100 mg BID plus adagrasib 400 mg BID for up to 2 years.
- id
- OG001
- title
- INCB099280 100 mg BID Plus Adagrasib 400 mg BID
- param Type
- NUMBER
- population Description
- Full Analysis Set: all participants who received at least 1 dose of INCB099280 or adagrasib. Participants were analyzed according to the treatment to which they were assigned. Confidence intervals were calculated using the Clopper-Pearson method.
- reporting Status
- POSTED
- time Frame
- up to 470 days
- title
- Objective Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice
Triangle