NCT00628251 · FLOW

Participant flow

Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer · Source last updated 2019-12-05

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

groups

description
Olaparib (AZD2281) 200 mg oral capsules twice daily
id
FG000
title
Olaparib 200 mg bd
description
Olaparib (AZD2281) 400 mg oral capsules twice daily
id
FG001
title
Olaparib 400 mg bd
description
Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
id
FG002
title
Liposomal Doxorubicin

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
1
type
Withdrawal by Subject
milestones
achievements
comment
Patients randomised
group Id
FG000
num Subjects
32
comment
Patients randomised
group Id
FG001
num Subjects
32
comment
Patients randomised
group Id
FG002
num Subjects
33
type
STARTED
achievements
comment
Patients who received olaparib treatment
group Id
FG000
num Subjects
32
comment
Patients who received olaparib treatment
group Id
FG001
num Subjects
32
comment
1 of 33 patients did not receive Liposomal Doxorubicin. Patient voluntarily discontinued
group Id
FG002
num Subjects
32
type
COMPLETED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
1
type
NOT COMPLETED
title
Randomised Part
drop Withdraws
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
2
group Id
FG002
num Subjects
3
type
Adverse Event
reasons
group Id
FG000
num Subjects
19
group Id
FG001
num Subjects
15
group Id
FG002
num Subjects
13
type
Condition under investigation worsened
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
2
group Id
FG002
num Subjects
1
type
Withdrawal by Subject
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
1
group Id
FG002
num Subjects
6
type
Other reason
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
2
type
Other
milestones
achievements
comment
Patients who received treatment
group Id
FG000
num Subjects
32
comment
Patients who received treatment
group Id
FG001
num Subjects
32
comment
Patients who received Liposomal doxorubicin 50 mg/m2
group Id
FG002
num Subjects
32
type
STARTED
achievements
group Id
FG000
num Subjects
22
group Id
FG001
num Subjects
20
group Id
FG002
num Subjects
25
type
Discontinued Initial Study Treatment
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
comment
Crossover dosage was 400 mg bd Olaparib
group Id
FG002
num Subjects
14
type
Crossover to Olaparib
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
5
type
Ongoing Crossover at DCO
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
9
type
Discontinued Crossover
achievements
comment
Ongoing initial study treatment at primary data cut-off
group Id
FG000
num Subjects
10
comment
Ongoing initial study treatment at primary data cut-off
group Id
FG001
num Subjects
12
comment
Patients ongoing initial study treatment (Liposomal doxorubicin)
group Id
FG002
num Subjects
7
type
COMPLETED
achievements
group Id
FG000
num Subjects
22
group Id
FG001
num Subjects
20
group Id
FG002
num Subjects
25
type
NOT COMPLETED
title
Ongoing Initial Study Treatment at DCO

pre Assignment Details

97 of 125 screened women with advanced BRCA 1/2 ovarian cancer who had chemotherapy were randomized

recruitment Details

First patient enrolled on 30 July 2008 and last patient on 3 March 2009 at 25 centres in 9 countries

Complete source fields