NCT01248949 · OUTCOME

Maximum Observed Serum Concentration (Cmax) 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: microgram per milliliter (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

Cmax is the maximum observed serum 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 microgram per milliliter (mcg/ml) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	1.39	0.254	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 microgram per milliliter (mcg/ml) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	2.44	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 microgram per milliliter (mcg/ml) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	6.63	3.48	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 microgram per milliliter (mcg/ml) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	50.2	28.8	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 microgram per milliliter (mcg/ml) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	82.4	2.68	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 microgram per milliliter (mcg/ml) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	239	79.5	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 microgram per milliliter (mcg/ml) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	785	189	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 ovarian cancer expansion (OCE) -1 (n=15)

Values in microgram per milliliter (mcg/ml) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	336	62.2	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 microgram per milliliter (mcg/ml) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	346	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 microgram per milliliter (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	30.4	26.8	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 microgram per milliliter (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	55.3	12.6	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 microgram per milliliter (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	235	90.5	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 microgram per milliliter (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	348	54.6	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 microgram per milliliter (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	44.5	39.3	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 microgram per milliliter (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	47.5	23.3	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 microgram per milliliter (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	116	35.1	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 microgram per milliliter (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	275	86.2	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 microgram per milliliter (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	320	170	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 microgram per milliliter (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	114	22.5	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 microgram per milliliter (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	209	57.4	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 microgram per milliliter (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	200	25.8	Not reported	Not reported	Not reported

Cohort MCP2 (n=3)

Values in microgram per milliliter (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	585	491	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.254
value
1.39
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
2.44
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
3.48
value
6.63
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
28.8
value
50.2
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
2.68
value
82.4
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
79.5
value
239
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
189
value
785
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
62.2
value
336
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 ovarian cancer expansion (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
346
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
26.8
value
30.4
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
12.6
value
55.3
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
90.5
value
235
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

Cmax is the maximum observed serum concentration 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

Maximum Observed Serum Concentration (Cmax) of MEDI3617

type

SECONDARY

unit Of Measure

microgram per milliliter (mcg/ml)

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Preserved source evidence · Not medical advice