NCT01379989

INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer

Phase III International, Randomized 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 617 (actual)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this multicentric, randomised, Phase III study is to demonstrate superiority, in terms of survival, of trabectedin and Pegylated Liposomal Doxorubicin (PLD) versus carboplatin and PLD in partially-platinum sensitive ovarian cancer patients.

Detailed description

Patients will be randomised to: Arm A: PLD 30 mg/m2 and carboplatin AUC 5; Arm B: PLD 30 mg/m2 and trabectedin 1.1 mg/m2. Patients' characteristics: patients over 18 years of age with advanced, progressive ovarian cancer 6-12 months after completion of first line or second line treatment with platinum-based chemotherapy.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin AUC 5
DRUG	Pegylated Lipoxomal Doxorubicin (PLD)	PLD 30 mg/m² i.v.
DRUG	Trabectedin	trabectedin 1.1 mg/m2 3-hour i.v. infusion on Day 1 every 3 weeks. The use of central venous access is strongly recommended.

Timeline

• Start date: 2011-06-01
• Primary completion: 2020-12-17
• Completion: 2020-12-17
• First posted: 2011-06-23
• Last updated: 2022-02-09

Locations

132 sites across 11 countries: Austria, Belgium, Denmark, Finland, Germany, Italy, Netherlands, Norway, Spain, Switzerland, United Kingdom