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

Phase 3 Completed 617 enrolled Mario Negri Institute for Pharmacological Research Averion International Corporation · collab PharmaMar · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2011-06
Primary completion: 2020-12-17
Completion: 2020-12-17

Outcome

Missed primary endpoint

paper CONCLUSIONS: This study did not meet the primary endpoint. PMID 36759720 ↗

paper The median OS was 21.4 for CP and 21.9 months for TP (HR 1.13; 95% CI: 0.94-1.35; p = 0.197). PMID 36759720 ↗

Publications

Colombo N, Gadducci A, Sehouli J, Rulli E, Maenpaa J, Sessa C, Montes A, Ottevanger NB, Berger R, Vergote I, D'Incalci M, Churruca Galaz C, Chekerov R, Nyvang GB, Riniker S, Herbertson R, Fossati R, Barretina-Ginesta MP, Deryal M, Mirza MR, Biagioli E, Iglesias M, Funari G, Romeo M, Tasca G, Pardo B, Tognon G, Rubio-Perez MJ, DeCensi A, De Giorgi U, Zola P, Benedetti Panici P, Aglietta M, Arcangeli V, Zamagni C, Bologna A, Westermann A, Heinzelmann-Schwarz V, Tsibulak I, Wimberger P, Poveda A; INOVATYON study group. INOVATYON/ ENGOT-ov5 study: Randomized phase III international study comparing trabectedin/pegylated liposomal doxorubicin (PLD) followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line. Br J Cancer. 2023 Apr;128(8):1503-1513. doi: 10.1038/s41416-022-02108-7. Epub 2023 Feb 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Carboplatin	Small molecule	5 unknown	—
Subject	Pegylated Lipoxomal Doxorubicin	Unknown	30 mg/m2	Intravenous
Subject	Trabectedin	Small molecule	1.1 mg/m2	Intravenous