A Phase 3 study comparing the combination of CAELYX and YONDELIS (the study drug) with CAELYX alone in subjects with advanced relapsed ovarian cancer who have previously had platinum based chemotherapy treatment (eg. Carboplatin/Cisplatin)
ET743-OVA-301 - A Phase 3, open-label multi-centre, randomized study to determine if the combination of CAELYX and YONDELIS (the study drug) improves progression free survival compared with CAELYX alone in subjects with advanced relapsed ovarian cancer in second line therapy
Johnson & Johnson Pharmaceutical Research & Development
650 participants
Aug 23, 2005
Interventional
Conditions
Summary
This study tests the safety and effectiveness of YONDELIS (the treatment being tested) used with CAELYX (a drug already used to treat cancer) compared to CAELYX alone. The purpose of this research study is to determine if the combination of YONDELIS and CAELYX is better at increasing the amount of time it takes for your cancer to progress compared to Caelyx alone. The study will also look at: response rate (how much your tumor shrinks in response to the drug) safety, and quality of life. In some consented patients, optional pharmacogenomic testing (DNA, RNA, and Protein testing) will occur which looks at the DNA in the tumour cells and how it responds to the study drug. The study, will examine the relationship between your response to treatment, disease progression and overall survival from your type of cancer.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Intervention - Yondelis (Trabectin) Patients will be randomised to receive either Caelyx 50mg/m2 as a 90 minute intravenous infusion every 4 weeks or Caelyx 30mg/m2 as a 90 minute intravenous infusion followed by Yondelis 1.1mg/m2 as a 3 hour intravenous infusion via central venous access every 3 weeks. Recruitment due to finish end June 2007. Patients will be followed until death or 2 months after the last subject has received the last dose of study drug or after 520 deaths.
Locations(1)
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ACTRN12607000169448