NCT01248949 · OUTCOME

Systemic Clearance (CL) 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: milliliter per day (mL/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

Systemic clearance describes the removal of drug from a volume of serum in a given unit of time (drug loss from the body). It is measured as milliliter per day (mL/day). 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 milliliter per day (mL/day) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	2790	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 milliliter per day (mL/day) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	2460	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 milliliter per day (mL/day) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	423	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 milliliter per day (mL/day) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	679	345	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 milliliter per day (mL/day) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	465	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 milliliter per day (mL/day) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	355	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 milliliter per day (mL/day) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	352	136	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 milliliter per day (mL/day) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	603	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 milliliter per day (mL/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	1060	426	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 milliliter per day (mL/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	614	363	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 milliliter per day (mL/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	388	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 milliliter per day (mL/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	797	499	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 milliliter per day (mL/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	847	237	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 milliliter per day (mL/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	501	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 milliliter per day (mL/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	216	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 milliliter per day (mL/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	727	157	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 milliliter per day (mL/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	356	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 milliliter per day (mL/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	446	NA	Not reported	Not reported	Standard deviation was not calculated due to limited sample size (n\<3).

Cohort MCP2 (n=2)

Values in milliliter per day (mL/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	424	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
2790
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
2460
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
423
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
345
value
679
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
465
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
355
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
136
value
352
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
603
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
426
value
1060
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
363
value
614
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
388
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
499
value
797
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

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

Systemic Clearance (CL) of MEDI3617

type

SECONDARY

unit Of Measure

milliliter per day (mL/day)

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Preserved source evidence · Not medical advice