INOVATYON.
Trial name or title | Phase III international, randomised study of trabectedin plus pegylated liposomal doxorubicin (PLD) versus carboplatin plus PLD in patients with ovarian cancer progressing within 6‐12 months of last platinum (ID: NCT01379989) |
Methods | Phase III multicentre RCT |
Participants | 558 women with ROC 6‐12 months after completion of first line treatment with platinum‐based chemotherapy |
Interventions | trabectedin + PLD (30 mg/m²) versus carboplatin + PLD (30 mg/m²). |
Outcomes | Primary: OS Secondary: PFS, ORR, CA125, duration of response, time to subsequent CT, safety |
Starting date | Jun 2010 |
Contact information | Nicoletta Colombo |
Notes | End Date: Dec 2017 Suspended due to the PLD shortage in 2011/12 |