An Observational Study of Avastin (Bevacizumab) and Interferon Alpha 2a in Patients With Metastatic Renal Cell Cancer (VERA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01392729
First received: July 11, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This prospective observational study will evaluate the efficacy and safety of Av astin (bevacizumab) in combination with interferon alpha 2a in patients with pre viously untreated metastatic renal cell cancer. Data will be collected from each patient for up to 4 years.


Condition
Renal Cell Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Open Label, Prospective, Observational, Local, Non-interventional Study of BeVacizumab (Avastin) and IntErpherone (IFN) Alpha 2a in Patients With Metastatic and Locally Advanced Renal Cell CAncer (VERA Study)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with previously untreated metastatic renal cell cancer

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically confirmed metastatic renal cell cancer, clear cell type
  • Eligible for treatment with Avastin and interferon alpha 2a according to local prescribing information

Exclusion Criteria:

  • Contraindications for Avastin or interferon alpha 2a treatment according to local Summary of Product Characteristics
  • Known hypersensitivity to Avastin and/or interferon alpha 2a or any of its excipients
  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: NCT01392729

Locations
Romania
Cluj-Napoca, Romania, 400015
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01392729     History of Changes
Other Study ID Numbers: ML25255
Study First Received: July 11, 2011
Last Updated: August 4, 2014
Health Authority: Romania: National Agency of Medicine and Medical Devices (MAMMD)

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014