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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.
Verified November 2016 by Hoffmann-La Roche
Sponsor:
ClinicalTrials.gov Identifier:
NCT01932125
First Posted: August 30, 2013
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: February 2018
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 27, 2013
First Posted: August 30, 2013
Last Update Posted: November 2, 2016
Last Verified: November 2016

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