mango slides fossati inovatyon
TRANSCRIPT
INOVATYON
INternational OVArian cancer patients Trial with YONdelis
• Study title: Phase III international, randomized study of Trabectedin plus PegylatedLiposomal Doxorubicin (PLD) versus Carboplatin plus PLD in patients with relapsed ovarian cancer progressing within 6-12 months of last platinum
• Sponsor: Mario Negri Institute, MaNGO group, Milan, Italy
• Principal Investigator: Nicoletta Colombo, European Oncology Institute,
Milan, Italy
111
1
33
23
49
23
13 4
5Germany 6
UK 5
Spain 4
Italy 3
The Netherlands 3
Belgium 2
Norway 1
Danmark 1
Austria 1
Finland 0
Switzerland 0
Sites to be opened
No. Participating sites: 162
No. Opened sites: 136
Enrollment by country
Total No. random: 342
173
25
13
21
63
25
7
1 pt every 2.6 days
about 11 pts per month
1 pt every 2 daysabout15 pts per
month
Targ
et
4
7
1
3
Enrollment expected vs. observed
0
100
200
300
400
500
randomized
randomized (expected)
assuming 1 pt every 2.6 days
assuming 1 pt every 2 days
Feb 2018
Jun 2017
Sept 2017