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

June 25, 2025 updated by: Hoffmann-La Roche

An Indian Multicentric, Open Label, Prospective Phase 4 Study of Bevacizumab in the Front Line Management of Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer in Real-life Clinical Practice

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Delhi, India, 110092
        • MAX Balaji Hospital
    • Delhi
      • New Delhi, Delhi, India, 110085
        • Rajiv Gandhi Cancer Inst.&Research Center
    • Karnataka
      • Bangalore, Karnataka, India, 560017
        • Manipal Hospital
      • Banglore, Karnataka, India, 560027
        • HealthCare Global Enterprises Limited
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431001
        • Marthwada Regional Cancer Center & Research Institute
      • Mumbai, Maharashtra, India, 400056
        • MOC Cancer Care & Research Centre
      • Nagpur, Maharashtra, India, 440026
        • HCG NCHRI Cancer Center
      • Nashik, Maharashtra, India, 422002
        • HCG Manavata Cancer Centre
      • Nashik, Maharashtra, India, 422009
        • Apex Wellness Hospital
      • Pune, Maharashtra, India, 411001
        • Grant Medical Foundation, Ruby Hall Clinic
      • Pune, Maharashtra, India, 411001
        • Jehangir Clinical Development Centre Pvt. Ltd
      • Pune, Maharashtra, India, 411004
        • Sahyadri Speciality Hospital
    • WEST Bengal
      • Kolkata, WEST Bengal, India, 700094
        • Peerless Hospitex Hospital and Research Center Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort
Drug: Bevacizumab
Participants will receive five cycles of bevacizumab 15 mg/kg concurrently with six cycles of the standard chemotherapy every three weeks (q3w), followed by extended cycles of bevacizumab 15 mg/kg q3w as a single agent for additional 16 cycles. A total of 21 cycles of bevacizumab will be administered in this study.
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: Incidence of adverse events
Time Frame: up to approximately 1.5 years
up to approximately 1.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: up to approximately 1.5 years
up to approximately 1.5 years
Overall survival
Time Frame: up to approximately 1.5 years
up to approximately 1.5 years
Overall response rate (complete response + partial response)
Time Frame: up to approximately 1.5 years
up to approximately 1.5 years
Clinical benefit rate (complete response + partial response + stable disease)
Time Frame: up to approximately 1.5 years
up to approximately 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2018

Primary Completion (Actual)

June 18, 2025

Study Completion (Actual)

June 18, 2025

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimated)

August 30, 2013

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28446

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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