TriangleNCT06039384 · OUTCOME
Number of Participants With Dose-limiting Toxicities (DLTs)
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
- up to Day 28
What was measured
DLTs were defined as protocol-defined toxicities occurring up to and including on Day 28, except those with a clear alternative explanation. Toxicities with a clear alternative explanation (e.g., due to disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination could have been deemed non-DLTs.
Analysis population: DLT-Evaluable Population: all participants in Part 1 who had a DLT by the end of the first treatment cycle, or received at least 75% of the planned doses during the first treatment cycle, or discontinued study treatment due to a DLT or treatment-related adverse event, even if adagrasib was not started
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 | 0 | Not reported | Not reported | Not reported | Not reported |
| INCB099280 100 mg BID Plus Adagrasib 400 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- DLTs were defined as protocol-defined toxicities occurring up to and including on Day 28, except those with a clear alternative explanation. Toxicities with a clear alternative explanation (e.g., due to disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination could have been deemed non-DLTs.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- DLT-Evaluable Population: all participants in Part 1 who had a DLT by the end of the first treatment cycle, or received at least 75% of the planned doses during the first treatment cycle, or discontinued study treatment due to a DLT or treatment-related adverse event, even if adagrasib was not started
- reporting Status
- POSTED
- time Frame
- up to Day 28
- title
- Number of Participants With Dose-limiting Toxicities (DLTs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice