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A study to observe the safety of Bevacizumab when it is added to the standard chemotherapy (carboplatin and paclitaxel)when it is routinely prescribed to patients of advanced/metastatic epithelial ovarian,fallopian tube or primary peritoneal cancer

AN INDIAN MULTICENTRIC OPEN LABEL PROSPECTIVE PHASE IV STUDY OF BEVACIZUMAB IN THE FRONT LINE MANAGEMENT OF ADVANCED/METASTATIC EPITHELIAL OVARIAN CANCER, FALLOPIAN TUBE CANCER OR PRIMARY PERITONEAL CANCER IN REAL CLINICAL PRACTICE

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2013/05/003627
Enrollment
100
Registered
2013-05-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Advanced/metastatic Epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer

Interventions

Intervention1: It is a data collection study no test product or intervention will be done for the study.: Data will be collected for bevacizumab, that is prescribed as per routine practice i.e 15 mg/k

Sponsors

Roche Products India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who are prescribed to receive bevacizumab or are already ongoing on treatment with bevacizumab for Advanced/metastatic epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (FIGO Stage lllb, lllc and lV) according to the routine clinical practice are eligible to enter this non-interventional study. Patients willing and able to give consent to data collection. Age is not defined in the protocol.

Exclusion criteria

Exclusion criteria: There is no specific exclusion criteria for this non-interventional study and patients who are considered not eligible to receive bevacizumab for advanced/metastatic epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (FIGO Stage IIIb, IIIc and IV) according to the local prescribing information will not be enrolled in the study

Design outcomes

Primary

MeasureTime frame
To determine the safety profile (all grade 3 and above adverse events) of bevacizumab when added to standard chemotherapy (carboplatin and paclitaxel) in front line advanced/metastatic epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (FIGO Stage IIIb, IIIc and IV) in Indian populationTimepoint: Upto 30 days after last dose of Bevacizumab

Secondary

MeasureTime frame
The Secondary objectives for this study are as follows: • Progression free survival (PFS) • Overall survival (OS) • Overall response rates (Complete response (CR)+ Partial response (PR)) • Clinical benefit response rates (CR+PR+ Stable disease(SD)) Timepoint: till end of study (Approx 1st Quarter 2015)

Countries

India

Contacts

Public ContactAmol Pawar

Roche Products India Pvt.Ltd

jyotii.poddaar@roche.com9136064373

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026