A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).
NCT ID: NCT00796757
Last Updated: 2015-05-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
146 participants
INTERVENTIONAL
2008-12-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
bevacizumab [Avastin]
10mg/kg iv infusion every 2 weeks
interferon alfa-2a
3 MIU sc t.i.w.
Interventions
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bevacizumab [Avastin]
10mg/kg iv infusion every 2 weeks
interferon alfa-2a
3 MIU sc t.i.w.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Olomouc, , Czechia
Prague, , Czechia
Tallinn, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Seinäjoki, , Finland
Turku, , Finland
Arnsberg, , Germany
Augsburg, , Germany
Berlin, , Germany
Berlin, , Germany
Freiburg im Breisgau, , Germany
Homburg/Saar, , Germany
Leipzig, , Germany
München, , Germany
Münster, , Germany
Offenburg, , Germany
Planegg, , Germany
Stuttgart, , Germany
Weiden, , Germany
Larissa, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Milan, , Italy
Napoli, , Italy
Pisa, , Italy
Kaunas, , Lithuania
Vilnius, , Lithuania
Amstelveen, , Netherlands
Eindhoven, , Netherlands
Maastricht, , Netherlands
Nijmegen, , Netherlands
Barnaul, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Obninsk, , Russia
Saint Petersburg, , Russia
Ufa, , Russia
Ulyanovsk, , Russia
Yekaterinburg, , Russia
Eskilstuna, , Sweden
Linköping, , Sweden
Sundsvall, , Sweden
Vaxjo, , Sweden
Aarau, , Switzerland
Locarno, , Switzerland
Zurich, , Switzerland
Cambridge, , United Kingdom
Cardiff, , United Kingdom
Countries
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References
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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-alpha2a 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.
Other Identifiers
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2007-006611-23
Identifier Type: -
Identifier Source: secondary_id
MO21609
Identifier Type: -
Identifier Source: org_study_id
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