TriangleNCT01772004 · OUTCOME
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Apparent Terminal Half-Life (t1/2) of Avelumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Hours
- Interval / dispersion
- Full Range
- 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
Apparent terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination.
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 | 61.425 | Not reported | 46.06 | 76.79 | Not reported |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 89.064 | Not reported | 43.09 | 115.95 | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 97.440 | Not reported | 52.15 | 120.08 | Not reported |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 108.671 | Not reported | 55.95 | 133.84 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 46.06
- upper Limit
- 76.79
- value
- 61.425
- group Id
- OG001
- lower Limit
- 43.09
- upper Limit
- 115.95
- value
- 89.064
- group Id
- OG002
- lower Limit
- 52.15
- upper Limit
- 120.08
- value
- 97.440
- group Id
- OG003
- lower Limit
- 55.95
- upper Limit
- 133.84
- value
- 108.671
- 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
- Apparent terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination.
- dispersion Type
- Full Range
- 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
- MEDIAN
- 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): Apparent Terminal Half-Life (t1/2) of Avelumab
- type
- SECONDARY
- unit Of Measure
- Hours
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Preserved source evidence · Not medical advice