Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer
NCT ID: NCT00719264
Last Updated: 2017-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
365 participants
INTERVENTIONAL
2008-11-12
2013-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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bevacizumab, RAD001 (everolimus)
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks
RAD001(everolimus)
10 mg qd
bevacizumab
10 mg/kg every 2 weeks
bevacizumab, interferon alfa-2a (IFN)
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks
interferon alfa-2a
dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3
bevacizumab
10 mg/kg every 2 weeks
Interventions
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RAD001(everolimus)
10 mg qd
interferon alfa-2a
dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3
bevacizumab
10 mg/kg every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with at least one measurable lesion
3. Patients with progressive metastatic renal cell carcinoma
4. Patients who had a prior partial or complete nephrectomy
5. Patients with a Karnofsky Performance Status ≥70%.
6. Adequate bone marrow function
7. Adequate liver function
8. Adequate renal function
9. Adequate coagulation profile
Exclusion Criteria
2. Patients who had radiation therapy within 28 days prior to start of study
3. Patients in need for major surgical procedure during the course of the study.
4. Patients with a serious non-healing wound, ulcer, or bone fracture.
5. Patients with a history of seizure(s) not controlled with standard medical therapy.
6. Patients who have received prior systemic treatment for their metastatic RCC.
7. Patients who received prior therapy with VEGF pathway inhibitor
8. Patients who have previously received systemic mTOR inhibitors
9. Patients with a known hypersensitivity RAD001 (everolimus) or other rapamycins or to its excipients.
10. Patients with history or current central nervous system (CNS) metastases or spinal cord compression.
11. Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
12. Patients with proteinuria at screening.
13. Patients with inadequately controlled hypertension
14. Patients receiving ongoing or with recent need for full therapeutic dose of oral or parenteral anticoagulants or chronic daily treatment with aspirin
15. Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
16. Patients with a known history of HIV
17. Patients with hypersensitivity to interferon alfa-2a or any component of the product.
18. Patients with an active, bleeding diathesis or coagulopathy or recurrent thromboembolism
19. Patients who have any severe and/or uncontrolled medical conditions or other conditions
20. Left Ventricular Ejection Fraction \< lower limit of institutional normal assessed by ECHO or MUGA
21. Patients who have a history of another primary malignancy ≤ 3 years
22. Female patients who are pregnant or breast feeding
23. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
24. Patients unwilling to or unable to comply with the protocol
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3)
Duarte, California, United States
USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
Los Angeles, California, United States
University of California at Los Angeles Dept. of Hem/Oncology
Los Angeles, California, United States
Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)
Detroit, Michigan, United States
Nevada Cancer Institute Dept. of Nevada Cancer (3)
Las Vegas, Nevada, United States
St. Luke's Hospital and Health Network St. Luke's Cancer Network
Bethlehem, Pennsylvania, United States
Las Colinas Hematology Oncology Grapevine
Irving, Texas, United States
Seattle Cancer Care Alliance Dept. of SCCA
Seattle, Washington, United States
Novartis Investigative Site
Brussels, , Belgium
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Brussels, , Belgium
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Charleroi, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Ribeirão Preto, São Paulo, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Olomouc, , Czechia
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Prague, , Czechia
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Cairo, Egypt, Egypt
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Cairo, , Egypt
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Strasbourg, Cedex, France
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Suresnes, France, France
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Avignon, , France
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Bordeaux, , France
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Caen, , France
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La Roche-sur-Yon, , France
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Montellier Cedex 5, , France
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Nantes, , France
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Reims, , France
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Rouen, , France
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Strasbourg, , France
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Toulouse, , France
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Berlin, , Germany
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Berlin, , Germany
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Dessau, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Frankfurt, , Germany
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Göttingen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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Tübingen, , Germany
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Shatin, New Territories, Hong Kong, Hong Kong
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Tuenmen, Hong Kong, Hong Kong
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Budapest, , Hungary
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Budapest, , Hungary
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Brescia, BS, Italy
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Cremona, CR, Italy
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Catanzaro, CZ, Italy
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Florence, FI, Italy
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Milan, MI, Italy
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Modena, MO, Italy
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Perugia, PG, Italy
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Aviano, PN, Italy
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Pavia, PV, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Trento, TN, Italy
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Negrar, VR, Italy
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Napoli, , Italy
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Leiden, Netherlands, Netherlands
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Moscow, Moscow, Russia
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Obninsk, Russia, Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Singapore, Singapore, Singapore
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Johannesburg, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Goyang-si, Gyeonggi-do, South Korea
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Seoul, Korea, South Korea
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Daegu, , South Korea
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Seoul, , South Korea
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Taegu, , South Korea
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Jaén, Andalusia, Spain
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Barcelona, Barcelona, Spain
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Santander, Cantabria, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Zaragoza, Zaragoza, Spain
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Santander, , Spain
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Bern, Switzerland, Switzerland
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Chur, , Switzerland
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Taichung, Taiwan, Taiwan
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Taipei, Taiwan, Taiwan
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Taipei, Taiwan, Taiwan
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Taipei, Taiwan, ROC, Taiwan
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Linkou District, , Taiwan
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Bangkok, , Thailand
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Songkhla, , Thailand
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Adana, Turkey, Turkey (Türkiye)
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Ankara, Turkey, Turkey (Türkiye)
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Bursa, Turkey, Turkey (Türkiye)
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Altunizade, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Balcova / Izmir, , Turkey (Türkiye)
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Mecidiyekoy/Istanbul, , Turkey (Türkiye)
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Northwood, Middlesex, United Kingdom
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Glasgow, , United Kingdom
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Southampton, , United Kingdom
Countries
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References
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Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
Ravaud A, Barrios CH, Alekseev B, Tay MH, Agarwala SS, Yalcin S, Lin CC, Roman L, Shkolnik M, Anak O, Gogov S, Pelov D, Louveau AL, Melichar B. RECORD-2: phase II randomized study of everolimus and bevacizumab versus interferon alpha-2a and bevacizumab as first-line therapy in patients with metastatic renal cell carcinoma. Ann Oncol. 2015 Jul;26(7):1378-84. doi: 10.1093/annonc/mdv170. Epub 2015 Apr 7.
Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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2008-000077-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRAD001L2201
Identifier Type: -
Identifier Source: org_study_id
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