NCT01772004 · OUTCOME

Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Maximum Observed Serum Concentration (Cmax) of Avelumab

Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor) · Source last updated 2021-12-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: Micrograms per milliliter (mcg/mL)
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

Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.

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.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Dose Escalation Cohort: Avelumab 1.0 mg/kg	4
Dose Escalation Cohort: Avelumab 3.0 mg/kg	13
Dose Escalation Cohort: Avelumab 10.0 mg/kg	15
Dose Escalation Cohort: Avelumab 20.0 mg/kg	21

Reported measurements

Source class 1

Values in Micrograms per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Dose Escalation Cohort: Avelumab 1.0 mg/kg	18.7	3.96	Not reported	Not reported	Not reported
Dose Escalation Cohort: Avelumab 3.0 mg/kg	81.9	22.1	Not reported	Not reported	Not reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg	249.048	55.4697	Not reported	Not reported	Not reported
Dose Escalation Cohort: Avelumab 20.0 mg/kg	489	140	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
3.96
value
18.7
group Id
OG001
spread
22.1
value
81.9
group Id
OG002
spread
55.4697
value
249.048
group Id
OG003
spread
140
value
489

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
13
group Id
OG002
value
15
group Id
OG003
value
21
units
Participants

description

Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.

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.

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): Maximum Observed Serum Concentration (Cmax) of Avelumab

type

SECONDARY

unit Of Measure

Micrograms per milliliter (mcg/mL)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice