NCT00974311 · FLOW

Participant flow

Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy · Source last updated 2018-12-11

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

groups

description
In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).
id
FG000
title
Enzalutamide
description
In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase).
id
FG001
title
Placebo

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
5
group Id
FG001
num Subjects
2
type
Lost to Follow-up
reasons
group Id
FG000
num Subjects
561
group Id
FG001
num Subjects
298
type
Death
reasons
group Id
FG000
num Subjects
16
group Id
FG001
num Subjects
7
type
Withdrawal by Subject
reasons
group Id
FG000
num Subjects
108
group Id
FG001
num Subjects
42
type
Study Terminated by Sponsor
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
type
Other
milestones
achievements
group Id
FG000
num Subjects
800
group Id
FG001
num Subjects
399
type
STARTED
achievements
group Id
FG000
num Subjects
109
group Id
FG001
num Subjects
50
type
COMPLETED
achievements
group Id
FG000
num Subjects
691
group Id
FG001
num Subjects
349
type
NOT COMPLETED
title
DB Phase (up to 24 Months)
drop Withdraws
reasons
group Id
FG000
num Subjects
14
group Id
FG001
num Subjects
21
type
Death
reasons
group Id
FG000
num Subjects
78
group Id
FG001
num Subjects
26
type
Study Terminated by Sponsor
reasons
group Id
FG000
num Subjects
15
group Id
FG001
num Subjects
2
type
Other
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
1
type
Withdrawal by Subject
milestones
achievements
group Id
FG000
num Subjects
109
group Id
FG001
num Subjects
50
type
STARTED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
109
group Id
FG001
num Subjects
50
type
NOT COMPLETED
title
OLE Phase (up to 77 Months)

pre Assignment Details

Participants were randomized 2:1 to receive either Enzalutamide or Placebo in DB phase. All participants who continued in OLE phase, received Enzalutamide.

recruitment Details

A total of 1199 participants were enrolled and randomized for double-blind (DB) phase. Out of which, 159 participants entered the optional open-label extension (OLE) phase.

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