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

NCT01932125CompletedPHASE4INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Hoffmann-La Roche

Enrollment

100

Start Date

2018-12-05

Completion Date

2025-06-18

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Bevacizumab

Conditions

Ovarian NeoplasmsPeritoneal NeoplasmsFallopian Tube Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Safety: Incidence of adverse events

Time frame: up to approximately 1.5 years

Secondary Outcomes

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

Locations

Manipal Hospital, Bangalore, India

HealthCare Global Enterprises Limited, Banglore, India

Marthwada Regional Cancer Center & Research Institute, Aurangabad, India

MOC Cancer Care & Research Centre, Mumbai, India

HCG NCHRI Cancer Center, Nagpur, India

HCG Manavata Cancer Centre, Nashik, India

Apex Wellness Hospital, Nashik, India

Grant Medical Foundation, Ruby Hall Clinic, Pune, India

Jehangir Clinical Development Centre Pvt. Ltd, Pune, India

Sahyadri Speciality Hospital, Pune, India

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

Peerless Hospitex Hospital and Research Center Ltd., Kolkata, India

MAX Balaji Hospital, Delhi, India

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