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