NCT05074940 · OUTCOME
Overall Response Rate Measured by RECIST Criteria
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
- 2 years
What was measured
To determine the overall response rate in patients with recurrent and metastatic adenoid cystic carcinoma treated with amivantamab. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."
Analysis population: 3 patients were unevaluable and excluded from efficacy analyses for discontinuing amivantamab treatment before first restaging. Thus, 18 subjects were included for analyses.
Groups in this outcome
Amivantamab
Amivantamab weekly for the first cycle and biweekly thereafter. Amivantamab: Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
| Group | Source count |
|---|---|
| Amivantamab | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Amivantamab | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 18
- units
- Participants
- description
- To determine the overall response rate in patients with recurrent and metastatic adenoid cystic carcinoma treated with amivantamab. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."
- groups
- description
- Amivantamab weekly for the first cycle and biweekly thereafter. Amivantamab: Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
- id
- OG000
- title
- Amivantamab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 3 patients were unevaluable and excluded from efficacy analyses for discontinuing amivantamab treatment before first restaging. Thus, 18 subjects were included for analyses.
- reporting Status
- POSTED
- time Frame
- 2 years
- title
- Overall Response Rate Measured by RECIST Criteria
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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