Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Carboplatin

Doxorubicin

Liposomal doxorubicin

Trabectedin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Pegylated Lipoxomal Doxorubicin (PLD) 30 mg/ m2 followed by carboplatin AUC 5.

Pegylated Lipoxomal Doxorubicin (PLD) 30 mg/m2 infusion followed by trabectedin 1.1 mg/m2 infusion.

Pegylated Lipoxomal Doxorubicin (PLD)

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.

Nicoletta Colombo, MD

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.

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.

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

This is an event driven study. The study will continue until 442 events have occurred.

PFS will be measured from the date of randomization to the date of documented PD or death (regardless of cause of death).

Objective RR will be the best response obtained in any evaluation according to RECIST 1.1

CA-125 serological response will be the best response obtained in each arm

Duration of response: will be calculated from the date of first documentation of response (CR or partial response \[PR\], whichever occurs first) to the date of documented PD or death.

The time from randomization to subsequent chemotherapy counted from the administration of subsequent chemotherapy will be evaluated as an exploratory analysis.

the overall survival counted from the administration of subsequent chemotherapy until death

the progression free survival counted from the administration of subsequent chemotherapy untill disease progression or death whichever occurs first

Number of SAEs for each randomization arm

Two PRO instruments will be administered in this study: the EORTC QLQ-C30 and QLQ-OV28.PRO instruments will be completed by the patient at screening (before randomization) and within four weeks after the 6th cycle or at the time of progression, whichever occurs first.

The best response obtained to each Subsequent chemotherapy line calculated as frequency of patients with CR, PR, SD or PD.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer	NCT01379989	Ovarian Cancer	Carboplatin Pegylated Lipox... Trabectedin	18 Years -	Mario Negri Institute for Pharmacological Research
INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer	NCT01379989	Ovarian Cancer	Carboplatin Pegylated Lipox... Trabectedin	18 Years -	Mario Negri Institute for Pharmacological Research

Spots Global Cancer Trial Database for pegylated lipoxomal doxorubicin (pld)