NCT01248949 · OUTCOME

Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) 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

AUC0-last is the Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration 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	41
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	16
MEDI3617 + BEVACIZUMAB Q2W TOTAL	35
MEDI3617 + PACLITAXEL TOTAL	13
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	7

Reported measurements

Cohort -2 (n=3)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	1.3	0.429	Not reported	Not reported	Not reported
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=2)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	2.2	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 1 (n=6)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	11.9	11.8	Not reported	Not reported	Not reported
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=3)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	171	69	Not reported	Not reported	Not reported
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	438	204	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=3)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	2610	1570	Not reported	Not reported	Not reported
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=4)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	3650	2600	Not reported	Not reported	Not reported
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=15)

Values in day*mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	2610	891	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	2160	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=4)

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	101	48.8	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	473	223	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 3A (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 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	2280	529	Not reported	Not reported	Not reported
MEDI3617 + BEVACIZUMAB Q2W TOTAL	NA	NA	Not reported	Not reported	Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.

Cohort MB 4A (n=6)

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	2710	1070	Not reported	Not reported	Not reported
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	94.7	48.7	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	216	61.8	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=8)

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	805	292	Not reported	Not reported	Not reported
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=8)

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	2310	941	Not reported	Not reported	Not reported
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 TT2A (n=9)

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 TT2A (participants with bevacizumab-refractory glioma), was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	NA	NA	Not reported	Not reported	Cohort TT2A (participants with bevacizumab-refractory glioma), was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + BEVACIZUMAB Q2W TOTAL	2590	1920	Not reported	Not reported	Not reported
MEDI3617 + PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort TT2A (participants with bevacizumab-refractory glioma), was part of the MEDI3617 + Bevacizumab Q2W Total group.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort TT2A (participants with bevacizumab-refractory glioma), was part of the MEDI3617 + Bevacizumab Q2W Total group.

Cohort MP1 (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 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	551	331	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=6)

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	1460	484	Not reported	Not reported	Not reported
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	NA	NA	Not reported	Not reported	Cohort MP2 was part of the MEDI3617 + Paclitaxel group.

Cohort MCP1 (n=4)

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	1240	882	Not reported	Not reported	Not reported

Cohort MCP2 (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 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	2890	257	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.429
value
1.3
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=3)
categories
measurements
comment
Standard deviation was not calculated due to limited sample size (n\<3).
group Id
OG000
spread
NA
value
2.2
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=2)
categories
measurements
group Id
OG000
spread
11.8
value
11.9
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=6)
categories
measurements
group Id
OG000
spread
69
value
171
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=3)
categories
measurements
group Id
OG000
spread
204
value
438
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
group Id
OG000
spread
1570
value
2610
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=3)
categories
measurements
group Id
OG000
spread
2600
value
3650
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=4)
categories
measurements
group Id
OG000
spread
891
value
2610
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=15)
categories
measurements
comment
Standard deviation was not calculated due to limited sample size (n\<3).
group Id
OG000
spread
NA
value
2160
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
48.8
value
101
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=4)
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
223
value
473
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 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG000
spread
NA
value
NA
group Id
OG001
spread
529
value
2280
comment
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG002
spread
NA
value
NA
comment
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG003
spread
NA
value
NA
comment
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
group Id
OG004
spread
NA
value
NA
title
Cohort MB 3A (n=3)

denoms

counts
group Id
OG000
value
41
group Id
OG001
value
16
group Id
OG002
value
35
group Id
OG003
value
13
group Id
OG004
value
7
units
Participants

description

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 the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617

type

SECONDARY

unit Of Measure

day*mcg/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice