NCT01693562 · OUTCOME

Maximum Serum Concentration (Cmax) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase

A Phase 1/2 Study to Evaluate MEDI4736 · Source last updated 2021-05-13

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

Measure: GEOMETRIC_MEAN
Unit: µg/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: After the first dose between Day 0 and Day 15 (Day 1 [pre and post dose] and predose of Dose 2 for all cohorts; Days 3, 5, 10 for Cohorts 0.1mg/kg to 10 mg/kg; Days 3, 5, 10, 15 for Cohort 15 mg/kg; Day 15 for Cohort 20 mg/kg)

What was measured

The Cmax of MEDI4736 is reported.

Analysis population: The PK evaluable population included all participants who received any dose of study drug and had at least one postdose PK concentration. Non-compartmental PK analysis was conducted using the data from dose escalation and exploration phases only. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure.

Groups in this outcome

Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)

Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)

Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first

Escalation Cohort (MEDI4736 1 mg/kg Q2W)

Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Escalation Cohort (MEDI4736 3 mg/kg Q2W)

Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.

Escalation Cohort (MEDI4736 10 mg/kg Q2W)

Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Escalation Cohort (MEDI4736 15 mg/kg Q3W)

Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Exploration Cohort (MEDI4736 20 mg/kg Q4W)

Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

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
Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)	4
Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)	4
Escalation Cohort (MEDI4736 1 mg/kg Q2W)	3
Escalation Cohort (MEDI4736 3 mg/kg Q2W)	3
Escalation Cohort (MEDI4736 10 mg/kg Q2W)	5
Escalation Cohort (MEDI4736 15 mg/kg Q3W)	7
Exploration Cohort (MEDI4736 20 mg/kg Q4W)	18

Reported measurements

Source class 1

Values in µg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)	2.780	22.1	Not reported	Not reported	Not reported
Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)	7.969	23.0	Not reported	Not reported	Not reported
Escalation Cohort (MEDI4736 1 mg/kg Q2W)	22.773	11.3	Not reported	Not reported	Not reported
Escalation Cohort (MEDI4736 3 mg/kg Q2W)	70.807	17.0	Not reported	Not reported	Not reported
Escalation Cohort (MEDI4736 10 mg/kg Q2W)	293.540	23.4	Not reported	Not reported	Not reported
Escalation Cohort (MEDI4736 15 mg/kg Q3W)	427.085	25.5	Not reported	Not reported	Not reported
Exploration Cohort (MEDI4736 20 mg/kg Q4W)	416.051	23.9	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
22.1
value
2.780
group Id
OG001
spread
23.0
value
7.969
group Id
OG002
spread
11.3
value
22.773
group Id
OG003
spread
17.0
value
70.807
group Id
OG004
spread
23.4
value
293.540
group Id
OG005
spread
25.5
value
427.085
group Id
OG006
spread
23.9
value
416.051

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
4
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
5
group Id
OG005
value
7
group Id
OG006
value
18
units
Participants

description

The Cmax of MEDI4736 is reported.

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
OG000
title
Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)
description
Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first
id
OG001
title
Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)
description
Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
OG002
title
Escalation Cohort (MEDI4736 1 mg/kg Q2W)
description
Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
id
OG003
title
Escalation Cohort (MEDI4736 3 mg/kg Q2W)
description
Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
OG004
title
Escalation Cohort (MEDI4736 10 mg/kg Q2W)
description
Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
OG005
title
Escalation Cohort (MEDI4736 15 mg/kg Q3W)
description
Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
OG006
title
Exploration Cohort (MEDI4736 20 mg/kg Q4W)

param Type

GEOMETRIC_MEAN

population Description

The PK evaluable population included all participants who received any dose of study drug and had at least one postdose PK concentration. Non-compartmental PK analysis was conducted using the data from dose escalation and exploration phases only. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure.

reporting Status

POSTED

time Frame

After the first dose between Day 0 and Day 15 (Day 1 [pre and post dose] and predose of Dose 2 for all cohorts; Days 3, 5, 10 for Cohorts 0.1mg/kg to 10 mg/kg; Days 3, 5, 10, 15 for Cohort 15 mg/kg; Day 15 for Cohort 20 mg/kg)

title

Maximum Serum Concentration (Cmax) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase

type

SECONDARY

unit Of Measure

µg/mL

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Preserved source evidence · Not medical advice