Clinical Trial: An Observational Study of Avastin (Bevacizumab) in Patients With Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: An Indian Multicentric Open Label Prospective Post Marketing Surveillance Study of Bevacizumab in the Front Line Management of Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or P
Brief Summary: This multicenter prospective observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in routine clinical practice in patients with advanced/metastatic epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. Data will be collected from eligible patients until death, withdrawal of consent, loss to follow-up, or study closure.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: Safety: Incidence of adverse events [ Time Frame: up to approximately 1.5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Progression-free survival [ Time Frame: up to approximately 1.5 years ]
- Overall survival [ Time Frame: up to approximately 1.5 years ]
- Overall response rate (complete response + partial response) [ Time Frame: up to approximately 1.5 years ]
- Clinical benefit rate (complete response + partial response + stable disease) [ Time Frame: up to approximately 1.5 years ]
Original Secondary Outcome: Same as current
Information By: Hoffmann-La Roche
Dates:
Date Received: August 27, 2013
Date Started: February 2018
Date Completion: March 2021
Last Updated: November 1, 2016
Last Verified: November 2016
