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

NCT01379989 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 617

Last updated 2022-02-09

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • PharmaMar

    collaborator INDUSTRY

  • Averion International Corporation

    collaborator INDUSTRY

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Nicoletta Colombo, MD · European Institute of Oncology (I.E.O), Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2020-12-17
Completion
2020-12-17

Countries

  • Austria
  • Belgium
  • Denmark
  • Finland
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01379989 on ClinicalTrials.gov