An Interventional Study of Avastin (Bevacizumab) in Patients With Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer

Phase 4

Active, not recruiting

• Conditions: Ovarian Neoplasms; Peritoneal Neoplasms; Fallopian Tube Neoplasms
• Interventions: Drug: Bevacizumab

• Registration Number: NCT01932125
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This multicenter prospective 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 Description

Not available

Study Timeline

• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-30
• Study Start: 2018-12-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-27
• Last Update Posted: 2024-12-30
• Primary Completion: 2025-06-21
• Study Completion: 2025-06-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Prescribed to receive bevacizumab or already ongoing on treatment with bevacizumab for advanced/metastatic ovarian cancer, fallopian tube cancer or primary peritoneal cancer (FIGO Stage IIIb, IIIc and IV) according to routine clinical practice

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Exclusion Criteria

• Not eligible for treatment with bevacizumab according to the local prescribing information

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort	Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	up to approximately 1.5 years

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	up to approximately 1.5 years
Overall survival	up to approximately 1.5 years
Overall response rate (complete response + partial response)	up to approximately 1.5 years
Clinical benefit rate (complete response + partial response + stable disease)	up to approximately 1.5 years

Trial Locations

Locations (13)

Rajiv Gandhi Cancer Inst.&Research Center; 🇮🇳 New Delhi, Delhi, India

Manipal Hospital; 🇮🇳 Bangalore, Karnataka, India

HealthCare Global Enterprises Limited; 🇮🇳 Banglore, Karnataka, India

Jehangir Clinical Development Centre Pvt. Ltd; 🇮🇳 Pune, Maharashtra, India

Marthwada Regional Cancer Center & Research Institute; 🇮🇳 Aurangabad, Maharashtra, India

MOC Cancer Care & Research Centre; 🇮🇳 Mumbai, Maharashtra, India

HCG NCHRI Cancer Center; 🇮🇳 Nagpur, Maharashtra, India

HCG Manavata Cancer Centre; 🇮🇳 Nashik, Maharashtra, India

Apex Wellness Hospital; 🇮🇳 Nashik, Maharashtra, India

Grant Medical Foundation, Ruby Hall Clinic; 🇮🇳 Pune, Maharashtra, India

Sahyadri Speciality Hospital; 🇮🇳 Pune, Maharashtra, India

Peerless Hospitex Hospital and Research Center Ltd.; 🇮🇳 Kolkata, WEST Bengal, India

MAX Balaji Hospital; 🇮🇳 Delhi, India