NCT01248949 · OUTCOME

Objective Response Rate (ORR)

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: NUMBER
Unit: Participants
Interval / dispersion: Not reported
Time frame: Time from the first dose of investigational product until end of study

What was measured

Objective response rate defined as the number of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (\<) 10 millimeter (the sum may not be "0" if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Analysis population: Safety population included all participants who received treatment with MEDI3617.

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	42
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	16
MEDI3617 + BEVACIZUMAB Q2W TOTAL	38
MEDI3617 + PACLITAXEL TOTAL	13
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	7

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
MEDI3617 SINGLE AGENT TOTAL	1	Not reported	Not reported	Not reported	Not reported
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	1	Not reported	Not reported	Not reported	Not reported
MEDI3617 + BEVACIZUMAB Q2W TOTAL	2	Not reported	Not reported	Not reported	Not reported
MEDI3617 + PACLITAXEL TOTAL	2	Not reported	Not reported	Not reported	Not reported
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
2
group Id
OG003
value
2
group Id
OG004
value
0

denoms

counts
group Id
OG000
value
42
group Id
OG001
value
16
group Id
OG002
value
38
group Id
OG003
value
13
group Id
OG004
value
7
units
Participants

description

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

NUMBER

population Description

Safety population included all participants who received treatment with MEDI3617.

reporting Status

POSTED

time Frame

Time from the first dose of investigational product until end of study

title

Objective Response Rate (ORR)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice