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A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00796757
First received: November 21, 2008
Last updated: October 17, 2013
Last verified: October 2013

November 21, 2008
October 17, 2013
December 2008
February 2012   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00796757 on ClinicalTrials.gov Archive Site
Objective response rate; overall survival; NCI-CTC Grade 3-5 adverse event rate until disease progression; overall adverse event rate and serious adverse event rate until disease progression. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).
An Open Label Study of the Effect of First Line Treatment With Avastin (Bevacizumab) in Combination With Low-dose Interferon on Progression-free Survival in Patients With Metastatic Clear Cell Renal Cell Carcinoma.

This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Cell Cancer
  • Drug: bevacizumab [Avastin]
    10mg/kg iv infusion every 2 weeks
  • Drug: interferon alfa-2a
    3 MIU sc t.i.w.
Experimental: 1
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: interferon alfa-2a
Melichar B, Bracarda S, Matveev V, Alekseev B, Ivanov S, Zyryanov A, Janciauskiene R, Fernebro E, Mulders P, Osborne S, Jethwa S, Mickisch G, Gore M, van Moorselaar RJ, Staehler M, Magne N, Bellmunt J; BEVLiN Investigators. A multinational phase II trial of bevacizumab with low-dose interferon-α2a as first-line treatment of metastatic renal cell carcinoma: BEVLiN. Ann Oncol. 2013 Sep;24(9):2396-402. doi: 10.1093/annonc/mdt228. Epub 2013 Jun 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • metastatic RCC with majority (>50%) of conventional clear-cell type;
  • prior total nephrectomy for primary RCC;
  • at least one measurable or non-measurable lesions;
  • ECOG performance score of 0 or 2.

Exclusion Criteria:

  • prior systemic treatment for metastatic RCC;
  • current or previously treated but non-stable CNS metastases or spinal cord compression;
  • major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment;
  • significant cardiovascular disease within 6 months prior to enrollment.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Estonia,   Finland,   Germany,   Greece,   Italy,   Lithuania,   Netherlands,   Russian Federation,   Sweden,   Switzerland,   United Kingdom
 
NCT00796757
MO21609, 2007-006611-23
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP