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
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 t1/2 is the time in days required for the concentration of the drug to reach half of its original value. 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 · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEDI3617 SINGLE AGENT TOTAL
0.585
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 · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEDI3617 SINGLE AGENT TOTAL
1.26
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 · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEDI3617 SINGLE AGENT TOTAL
5.86
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 · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEDI3617 SINGLE AGENT TOTAL
5.98
3.09
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 · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEDI3617 SINGLE AGENT TOTAL
7.68
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 · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEDI3617 SINGLE AGENT TOTAL
7.79
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 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 · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEDI3617 SINGLE AGENT TOTAL
10.4
3.15
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 · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEDI3617 SINGLE AGENT TOTAL
9.03
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 · 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
3.59
0.983
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 · 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
9.67
3.35
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 · 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
12.3
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 · 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
3.9
2.69
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 · 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
5.12
0.541
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 · 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
8.23
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 · 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
10.2
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 · 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
6.96
1.59
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 · 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
9.34
NA
Not reported
Not reported
Standard deviation was not calculated due to limited sample size (n\<3).
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 · 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
15.1
NA
Not reported
Not reported
Standard deviation was not calculated due to limited sample size (n\<3).
Cohort MCP2 (n=2)
Values in day · 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
11.1
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
0.585
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
1.26
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
5.86
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
3.09
value
5.98
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
7.68
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
7.79
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
3.15
value
10.4
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
9.03
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
0.983
value
3.59
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
3.35
value
9.67
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
12.3
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
2.69
value
3.9
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 t1/2 is the time in days required for the concentration of the drug to reach half of its original value. 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
Triangle