TriangleNCT01772004 · OUTCOME
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Avelumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Hours*micrograms per milliliter
- Interval / dispersion
- Standard Deviation
- Time frame
- Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion
What was measured
The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Analysis population: Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.
Groups in this outcome
Dose Escalation Cohort: Avelumab 1.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
Dose Escalation Cohort: Avelumab 3.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Dose Escalation Cohort: Avelumab 10.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Dose Escalation Cohort: Avelumab 20.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
| Group | Source count |
|---|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 2 |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 12 |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 13 |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 1290 | 650 | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 6850 | 2100 | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 25920.9 | 6753.76 | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 46600 | 18500 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 650
- value
- 1290
- group Id
- OG001
- spread
- 2100
- value
- 6850
- group Id
- OG002
- spread
- 6753.76
- value
- 25920.9
- group Id
- OG003
- spread
- 18500
- value
- 46600
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 15
- units
- Participants
- description
- The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
- id
- OG000
- title
- Dose Escalation Cohort: Avelumab 1.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG001
- title
- Dose Escalation Cohort: Avelumab 3.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG002
- title
- Dose Escalation Cohort: Avelumab 10.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG003
- title
- Dose Escalation Cohort: Avelumab 20.0 mg/kg
- param Type
- MEAN
- population Description
- Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion
- title
- Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Avelumab
- type
- SECONDARY
- unit Of Measure
- Hours*micrograms per milliliter
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice