NCT01761240 · FLOW

Participant flow

Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC · Source last updated 2024-03-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

description
Participants received MORAb-066 0.1 milligram per kilogram (mg/kg), infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
id
FG000
title
MORAb-066 0.1 mg/kg
description
Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
id
FG001
title
MORAb-066 0.3 mg/kg
description
Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
id
FG002
title
MORAb-066 1 mg/kg
description
Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
id
FG003
title
MORAb-066 2 mg/kg
description
Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
id
FG004
title
MORAb-066 3 mg/kg

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
3
group Id
FG002
num Subjects
0
group Id
FG003
num Subjects
0
group Id
FG004
num Subjects
0
type
Progressive disease:radiology assessment
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
3
group Id
FG003
num Subjects
1
group Id
FG004
num Subjects
0
type
Progressive disease:clinical assessment
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
group Id
FG003
num Subjects
3
group Id
FG004
num Subjects
1
type
Withdrawal by Subject
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
group Id
FG003
num Subjects
1
group Id
FG004
num Subjects
6
type
Adverse Event
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
1
group Id
FG002
num Subjects
1
group Id
FG003
num Subjects
2
group Id
FG004
num Subjects
1
type
Death
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
1
group Id
FG003
num Subjects
0
group Id
FG004
num Subjects
0
type
Non-compliance
milestones
achievements
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
4
group Id
FG002
num Subjects
5
group Id
FG003
num Subjects
7
group Id
FG004
num Subjects
8
type
STARTED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
group Id
FG003
num Subjects
0
group Id
FG004
num Subjects
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
4
group Id
FG002
num Subjects
5
group Id
FG003
num Subjects
7
group Id
FG004
num Subjects
8
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

A total of 27 participants were enrolled and treated in the study.

recruitment Details

Participants took part in the study at 2 investigative sites in the United States from 19 June 2013 to 09 February 2016.

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