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An Observational Study of Avastin (Bevacizumab) in Combination With Interferon Alpha-2a as First-Line Treatment in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT01351571
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with interferon alpha-2a as first-line treatment in patients with advanced and/or metastatic renal cell carcinoma. Data will be collected from each patient as per routine clinical practice of the Investigator (maximum of 52 weeks, until disease progression /unacceptable toxicity or withdrawal of consent) and/or based on the local label.

Condition or disease
Renal Cell Cancer

Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Open Label, Prospective, Observational, Non-interventional Study of Bevacizumab in Combination With Interferon Alpha-2a for the First-line Treatment of Patients With Advanced and/or Metastatic Renal Cell Carcinoma
Study Start Date : August 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Cohort



Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: approximately 4 years ]

Secondary Outcome Measures :
  1. Progression-free survival: time from first drug administration to documented disease progression or death of any cause [ Time Frame: approximately 4 years ]
  2. Overall response rate: complete response or partial response according to RECIST criteria [ Time Frame: approximately 4 years ]
  3. Overall survival [ Time Frame: approximately 4 years ]


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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 and/or metastatic renal cell carcinoma treated with Avastin and interferon alpha-2a
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Advanced and/or metastatic renal cell carcinoma
  • Receiving first-line treatment with Avastin and interferon alpha-2a according to standard of care and current local label
  • At least one measurable and non-measurable lesion according to RECIST criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate bone marrow, renal and liver function

Exclusion Criteria:

  • Contraindications to Avastin and/or interferon alpha-2a as per local label

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): NCT01351571


Locations
India
Aurangabad, India, 43100
Delhi, India, 110085
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01351571     History of Changes
Other Study ID Numbers: ML25251
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

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
Interferons
Interferon-alpha
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors