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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01932125
First received: August 27, 2013
Last updated: September 1, 2016
Last verified: September 2016
  Purpose
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.

Condition
Ovarian Cancer, Peritoneal Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 Primary Peritoneal Cancer in Real-life Clinical Practice

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: up to approximately 1.5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to approximately 1.5 years ] [ Designated as safety issue: No ]
  • Overall response rate (complete response + partial response) [ Time Frame: up to approximately 1.5 years ] [ Designated as safety issue: No ]
  • Clinical benefit rate (complete response + partial response + stable disease) [ Time Frame: up to approximately 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2017
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with advanced/metastatic epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer initiated on therapy with Avastin
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Prescribed to receive Avastin or already ongoing on treatment with Avastin 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 Avastin according to the local prescribing information
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932125

Contacts
Contact: Reference Study ID Number: ML28446 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
India
Not yet recruiting
Nashik, Maharashtra, India, 422004
Not yet recruiting
Kolkata, India, 700054
Not yet recruiting
Surat, India, 395002
Not yet recruiting
Vijayawada, India, 520002
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01932125     History of Changes
Other Study ID Numbers: ML28446 
Study First Received: August 27, 2013
Last Updated: September 1, 2016
Health Authority: India: Indian Health Authority-DCGI (Drug Controller General of India)

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Histologic Type
Abdominal Neoplasms
Digestive System Neoplasms
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Digestive System Diseases
Peritoneal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 29, 2016