NCT01248949 · OUTCOME

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617

A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors · Source last updated 2017-03-29

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

Measure: MEAN
Unit: day*mcg/mL
Interval / dispersion: Standard Deviation
Time frame: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose

What was measured

The AUC0-inf is the Area Under the Concentration-Time Curve From Time Zero to infinity of MEDI3617. Here, "n" is number of participants analyzed for this endpoint at a specific dose.

Analysis population: All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.

Groups in this outcome

MEDI3617 SINGLE AGENT TOTAL

Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.

MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL

Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.

MEDI3617 + BEVACIZUMAB Q2W TOTAL

Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.

MEDI3617 + PACLITAXEL TOTAL

Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.

MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL

Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.

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
MEDI3617 SINGLE AGENT TOTAL	25
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	8
MEDI3617 + BEVACIZUMAB Q2W TOTAL	13
MEDI3617 + PACLITAXEL TOTAL	4
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	3

Reported measurements

Cohort -2 (n=1)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	1.79	NA	Not reported	Not reported	Standard deviation was not calculated due to limited sample size (n\<3).
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort -2 was part of the MEDI3617 Single agent total group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort -2 was part of the MEDI3617 Single agent total group.
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort -2 was part of the MEDI3617 Single agent total group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort -2 was part of the MEDI3617 Single agent total group.

Cohort 1 (n=1)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	8.12	NA	Not reported	Not reported	Standard deviation was not calculated due to limited sample size (n\<3).
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort 1 was part of the MEDI3617 Single agent total group
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort 1 was part of the MEDI3617 Single agent total group
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort 1 was part of the MEDI3617 Single agent total group
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort 1 was part of the MEDI3617 Single agent total group

Cohort 2 (n=2)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	269	NA	Not reported	Not reported	Standard deviation was not calculated due to limited sample size (n\<3).
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort 2 was part of the MEDI3617 Single agent total group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort 2 was part of the MEDI3617 Single agent total group.
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort 2 was part of the MEDI3617 Single agent total group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort 2 was part of the MEDI3617 Single agent total group.

Cohort 3 (n=3)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	529	269	Not reported	Not reported	Not reported
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort 3 was part of the MEDI3617 Single agent total group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort 3 was part of the MEDI3617 Single agent total group.
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort 3 was part of the MEDI3617 Single agent total group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort 3 was part of the MEDI3617 Single agent total group.

Cohort 4 (n=2)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	2150	NA	Not reported	Not reported	Standard deviation was not calculated due to limited sample size (n\<3).
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort 4 was part of the MEDI3617 Single agent total group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort 4 was part of the MEDI3617 Single agent total group.
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort 4 was part of the MEDI3617 Single agent total group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort 4 was part of the MEDI3617 Single agent total group.

Cohort 5 (n=2)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	4230	NA	Not reported	Not reported	Standard deviation was not calculated due to limited sample size (n\<3).
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort 5 was part of the MEDI3617 Single agent total group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort 5 was part of the MEDI3617 Single agent total group.
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort 5 was part of the MEDI3617 Single agent total group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort 5 was part of the MEDI3617 Single agent total group.

Cohort OCE -1 (n=12)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	3280	1410	Not reported	Not reported	Not reported
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort OCE -1 was part of the MEDI3617 Single agent total group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort OCE -1 was part of the MEDI3617 Single agent total group.
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort OCE -1 was part of the MEDI3617 Single agent total group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort OCE -1 was part of the MEDI3617 Single agent total group.

Cohort OCE 1 (n=2)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	2490	NA	Not reported	Not reported	Standard deviation was not calculated due to limited sample size (n\<3).
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort OCE 1 was part of the MEDI3617 Single agent total group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort OCE 1 was part of the MEDI3617 Single agent total group.
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort OCE 1 was part of the MEDI3617 Single agent total group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort OCE 1 was part of the MEDI3617 Single agent total group.

Cohort MB 1A (n=3)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	NA	NA	Not reported	Not reported	Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	110	58.1	Not reported	Not reported	Not reported
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.

Cohort MB 2A (n=3)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	NA	NA	Not reported	Not reported	Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	628	376	Not reported	Not reported	Not reported
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.

Cohort MB 4A (n=2)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	NA	NA	Not reported	Not reported	Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	3920	NA	Not reported	Not reported	Standard deviation was not calculated due to limited sample size (n\<3).
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.

Cohort MB 1B (n=7)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	NA	NA	Not reported	Not reported	Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	104	61	Not reported	Not reported	Not reported
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.

Cohort MB 2B (n=3)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	NA	NA	Not reported	Not reported	Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	252	83.2	Not reported	Not reported	Not reported
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.

Cohort MB 3B (n=2)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	NA	NA	Not reported	Not reported	Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	1200	NA	Not reported	Not reported	Standard deviation was not calculated due to limited sample size (n\<3).
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.

Cohort MB 4B (n=1)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	NA	NA	Not reported	Not reported	Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	4630	NA	Not reported	Not reported	Standard deviation was not calculated due to limited sample size (n\<3).
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.

Cohort MP1 (n=3)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	NA	NA	Not reported	Not reported	Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
MEDI3617 + PACLITAXEL TOTAL	849	163	Not reported	Not reported	Not reported
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MP1 was part of the MEDI3617 + Paclitaxel group.

Cohort MP2 (n=1)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	NA	NA	Not reported	Not reported	Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
MEDI3617 + PACLITAXEL TOTAL	2810	NA	Not reported	Not reported	Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MP2 was part of the MEDI3617 + Paclitaxel group.

Cohort MCP1 (n=1)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	NA	NA	Not reported	Not reported	Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	2240	NA	Not reported	Not reported	Standard deviation was not calculated due to limited sample size (n\<3).

Cohort MCP2 (n=2)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	NA	NA	Not reported	Not reported	Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	3560	NA	Not reported	Not reported	Standard deviation was not calculated due to limited sample size (n\<3).

Complete source fields

classes

categories
measurements
comment
Standard deviation was not calculated due to limited sample size (n\<3).
group Id
OG000
spread
NA
value
1.79
comment
Cohort -2 was part of the MEDI3617 Single agent total group.
group Id
OG001
spread
NA
value
NA
comment
Cohort -2 was part of the MEDI3617 Single agent total group.
group Id
OG002
spread
NA
value
NA
comment
Cohort -2 was part of the MEDI3617 Single agent total group.
group Id
OG003
spread
NA
value
NA
comment
Cohort -2 was part of the MEDI3617 Single agent total group.
group Id
OG004
spread
NA
value
NA
title
Cohort -2 (n=1)
categories
measurements
comment
Standard deviation was not calculated due to limited sample size (n\<3).
group Id
OG000
spread
NA
value
8.12
comment
Cohort 1 was part of the MEDI3617 Single agent total group
group Id
OG001
spread
NA
value
NA
comment
Cohort 1 was part of the MEDI3617 Single agent total group
group Id
OG002
spread
NA
value
NA
comment
Cohort 1 was part of the MEDI3617 Single agent total group
group Id
OG003
spread
NA
value
NA
comment
Cohort 1 was part of the MEDI3617 Single agent total group
group Id
OG004
spread
NA
value
NA
title
Cohort 1 (n=1)
categories
measurements
comment
Standard deviation was not calculated due to limited sample size (n\<3).
group Id
OG000
spread
NA
value
269
comment
Cohort 2 was part of the MEDI3617 Single agent total group.
group Id
OG001
spread
NA
value
NA
comment
Cohort 2 was part of the MEDI3617 Single agent total group.
group Id
OG002
spread
NA
value
NA
comment
Cohort 2 was part of the MEDI3617 Single agent total group.
group Id
OG003
spread
NA
value
NA
comment
Cohort 2 was part of the MEDI3617 Single agent total group.
group Id
OG004
spread
NA
value
NA
title
Cohort 2 (n=2)
categories
measurements
group Id
OG000
spread
269
value
529
comment
Cohort 3 was part of the MEDI3617 Single agent total group.
group Id
OG001
spread
NA
value
NA
comment
Cohort 3 was part of the MEDI3617 Single agent total group.
group Id
OG002
spread
NA
value
NA
comment
Cohort 3 was part of the MEDI3617 Single agent total group.
group Id
OG003
spread
NA
value
NA
comment
Cohort 3 was part of the MEDI3617 Single agent total group.
group Id
OG004
spread
NA
value
NA
title
Cohort 3 (n=3)
categories
measurements
comment
Standard deviation was not calculated due to limited sample size (n\<3).
group Id
OG000
spread
NA
value
2150
comment
Cohort 4 was part of the MEDI3617 Single agent total group.
group Id
OG001
spread
NA
value
NA
comment
Cohort 4 was part of the MEDI3617 Single agent total group.
group Id
OG002
spread
NA
value
NA
comment
Cohort 4 was part of the MEDI3617 Single agent total group.
group Id
OG003
spread
NA
value
NA
comment
Cohort 4 was part of the MEDI3617 Single agent total group.
group Id
OG004
spread
NA
value
NA
title
Cohort 4 (n=2)
categories
measurements
comment
Standard deviation was not calculated due to limited sample size (n\<3).
group Id
OG000
spread
NA
value
4230
comment
Cohort 5 was part of the MEDI3617 Single agent total group.
group Id
OG001
spread
NA
value
NA
comment
Cohort 5 was part of the MEDI3617 Single agent total group.
group Id
OG002
spread
NA
value
NA
comment
Cohort 5 was part of the MEDI3617 Single agent total group.
group Id
OG003
spread
NA
value
NA
comment
Cohort 5 was part of the MEDI3617 Single agent total group.
group Id
OG004
spread
NA
value
NA
title
Cohort 5 (n=2)
categories
measurements
group Id
OG000
spread
1410
value
3280
comment
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
group Id
OG001
spread
NA
value
NA
comment
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
group Id
OG002
spread
NA
value
NA
comment
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
group Id
OG003
spread
NA
value
NA
comment
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
group Id
OG004
spread
NA
value
NA
title
Cohort OCE -1 (n=12)
categories
measurements
comment
Standard deviation was not calculated due to limited sample size (n\<3).
group Id
OG000
spread
NA
value
2490
comment
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
group Id
OG001
spread
NA
value
NA
comment
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
group Id
OG002
spread
NA
value
NA
comment
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
group Id
OG003
spread
NA
value
NA
comment
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
group Id
OG004
spread
NA
value
NA
title
Cohort OCE 1 (n=2)
categories
measurements
comment
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG000
spread
NA
value
NA
group Id
OG001
spread
58.1
value
110
comment
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG002
spread
NA
value
NA
comment
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG003
spread
NA
value
NA
comment
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG004
spread
NA
value
NA
title
Cohort MB 1A (n=3)
categories
measurements
comment
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG000
spread
NA
value
NA
group Id
OG001
spread
376
value
628
comment
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG002
spread
NA
value
NA
comment
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG003
spread
NA
value
NA
comment
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG004
spread
NA
value
NA
title
Cohort MB 2A (n=3)
categories
measurements
comment
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG000
spread
NA
value
NA
comment
Standard deviation was not calculated due to limited sample size (n\<3).
group Id
OG001
spread
NA
value
3920
comment
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG002
spread
NA
value
NA
comment
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG003
spread
NA
value
NA
comment
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG004
spread
NA
value
NA
title
Cohort MB 4A (n=2)
categories
measurements
comment
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
group Id
OG000
spread
NA
value
NA
comment
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
group Id
OG001
spread
NA
value
NA
group Id
OG002
spread
61
value
104
comment
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
group Id
OG003
spread
NA
value
NA
comment
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
group Id
OG004
spread
NA
value
NA
title
Cohort MB 1B (n=7)

denoms

counts
group Id
OG000
value
25
group Id
OG001
value
8
group Id
OG002
value
13
group Id
OG003
value
4
group Id
OG004
value
3
units
Participants

description

The AUC0-inf is the Area Under the Concentration-Time Curve From Time Zero to infinity of MEDI3617. Here, "n" is number of participants analyzed for this endpoint at a specific dose.

dispersion Type

Standard Deviation

groups

description
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
id
OG000
title
MEDI3617 SINGLE AGENT TOTAL
description
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
id
OG001
title
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
description
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
id
OG002
title
MEDI3617 + BEVACIZUMAB Q2W TOTAL
description
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
id
OG003
title
MEDI3617 + PACLITAXEL TOTAL
description
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
id
OG004
title
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL

param Type

MEAN

population Description

All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.

reporting Status

POSTED

time Frame

Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose

title

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617

type

SECONDARY

unit Of Measure

day*mcg/mL

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Preserved source evidence · Not medical advice