Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.
NCT ID: NCT01024920
Last Updated: 2021-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2009-12-16
2020-06-19
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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Nintedanib (BIBF 1120)
Non-marketed substance: Twice daily oral doses of 200mg BIBF 1120 given continuously.
BIBF 1120
VEGF inhibitor
sunitinib
Marketed substance: Once a day oral doses of 50mg sunitinib given in repeated 6 week cycles: 4 weeks active, 2 weeks rest.
sunitinib
VEGF inhibitor
Interventions
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BIBF 1120
VEGF inhibitor
sunitinib
VEGF inhibitor
Eligibility Criteria
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Inclusion Criteria
2. Histological-confirmed diagnosis of renal cell cancer with clear cell component.
3. Acceptable renal,liver,cardiovascular,bone marrow and other functions to allow sunitinib/BIBF 1120 treatment.
Exclusion Criteria
2. Treatment with other investigational drugs or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study.
3. Patients unable to comply with the 1199.26 protocol.
4. Pregnancy or breast feeding.
5. Active alcohol or drug abuse.
6. Women of child bearing potential, or men who are able to father a child, unwilling to use a medically acceptable form of contraception during the study period.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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University of Pecs Medical School, Dept. of Oncotherapy
Pécs, , Hungary
Ziemia Lubelska Oncological Center, Lublin
Lublin, , Poland
Onco.Cent. - Instit. of Maria Sklodowskiej-Curie
Warsaw, , Poland
Military Central Clinical Emergency Hospital
Bucharest, , Romania
Sf. Nectarie Oncology Center, Craiova
Craiova, , Romania
ONCOLAB SRL, Craiova
Craiova, , Romania
Municipal Establishment Cherkasy Oncology Centre
Cherkasy, , Ukraine
Bukovynsk State Medical University
Chernivtsi, , Ukraine
Munic.Instit."City Clin.Hosp.#4" of Dnipro City Council
Dnipropetrovks, , Ukraine
CI of LRC Lviv Onco.Reg.Treat.&Diag.Cent.
Lviv, , Ukraine
Uzhgorod National University, Oncology Centre
Uzhhorod, , Ukraine
Addenbrooke's Hospital
Cambridge, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Surrey Cancer Research Institute
Guildford, , United Kingdom
St James's University Hospital
Leeds, , 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.
Eisen T, Shparyk Y, Macleod N, Jones R, Wallenstein G, Temple G, Khder Y, Dallinger C, Studeny M, Loembe AB, Bondarenko I. Effect of small angiokinase inhibitor nintedanib (BIBF 1120) on QT interval in patients with previously untreated, advanced renal cell cancer in an open-label, phase II study. Invest New Drugs. 2013 Oct;31(5):1283-93. doi: 10.1007/s10637-013-9962-7. Epub 2013 Apr 27.
Related Links
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Related Info
Other Identifiers
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2009-009516-44
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1199.26
Identifier Type: -
Identifier Source: org_study_id
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