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Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01024920
Recruitment Status : Active, not recruiting
First Posted : December 3, 2009
Last Update Posted : January 13, 2020
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Compare safety and efficacy of BIBF 1120 versus sunitinib in patients with advanced RCC and to investigate the effects of BIBF 1120 on the heart rate (HR) corrected QT interval (QTcF).

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: BIBF 1120 Drug: sunitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, Open Label, Parallel Group Phase II Study Comparing the Efficacy and Tolerability of BIBF 1120 Versus Sunitinib in Previously Untreated Patients With Renal Cell Cancer
Study Start Date : December 16, 2009
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : March 28, 2020

Arm Intervention/treatment
Experimental: BIBF 1120
Non-marketed substance: Twice daily oral doses of 200mg BIBF 1120 given continuously.
Drug: BIBF 1120
VEGF inhibitor

Active Comparator: sunitinib
Marketed substance: Once a day oral doses of 50mg sunitinib given in repeated 6 week cycles: 4 weeks active, 2 weeks rest.
Drug: sunitinib
VEGF inhibitor

Primary Outcome Measures :
  1. Progression Free Survival at 9 months. [ Time Frame: 9 months of treatment ]
  2. For patients treated with with BIBF 1120. Change from baseline to endpoint (day 15) of the QT interval at each point in time QTcF (QT interval corrected by the Fridericia formula). [ Time Frame: 9 months of treatment ]

Secondary Outcome Measures :
  1. Progression Free survival [ Time Frame: 18 months ]
  2. Objective Response [ Time Frame: 36 months ]
  3. Duration of Response [ Time Frame: 36 months ]
  4. Overall Survival [ Time Frame: 36 months ]
  5. Time to treatment failure. [ Time Frame: 36 months ]
  6. Time to progression. [ Time Frame: 36 months ]
  7. BIBF 1120 patients only: - Change from baseline to Day 1 of QTcF interval at each point in time. - QTcF interval at the time of each patient's maximum BIBF 11230 concentration - Time-averaged QTcF interval over 1-12 hours. [ Time Frame: 15 Days ]
  8. Safety Endpoints all patients: Frequency of Adverse Events. -Number and duration of hospital stays due to Adverse Events -Dose-related dose reduction and discontinuation rate -Laboratory parameters graded by CTCAE v3 -PR and QRS intervals of ECG: [ Time Frame: 36 months ]
  9. BIBF 1120 patients only: - New onset of QT/QTc>500ms - New onset of QTc>470ms - New onset of QTc>450ms [ Time Frame: 15 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Patients with unresectable or metastatic Renal Cell Cancer, who have received no previous systemic anti-cancer treatment.
  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:

  1. Patients unable to tolerate Sunitinib/BIBF 1120 treatment
  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.

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 identifier (NCT number): NCT01024920

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University of Pecs Medical School, Dept. of Oncotherapy
Pecs, Hungary, 7624
Ziemia Lubelska Oncological Center, Lublin
Lublin, Poland, 20-099
Onco.Cent. - Instit. of Maria Sklodowskiej-Curie
Warszawa, Poland, 02-781
Military Central Clinical Emergency Hospital
Bucharest, Romania, 010825
Sf. Nectarie Oncology Center, Craiova
Craiova, Romania, 200347
Craiova, Romania, 200385
Municipal Establishment Cherkasy Oncology Centre
Cherkasy, Ukraine, 18009
Bukovynsk State Medical University
Chernivtsi, Ukraine, 58013
Munic.Instit."City Clin.Hosp.#4" of Dnipro City Council
Dnipropetrovks, Ukraine, 49102
CI of LRC Lviv Onco.Reg.Treat.&Diag.Cent.
Lviv, Ukraine, 79031
Uzhgorod National University, Oncology Centre
Uzhgorod, Ukraine, 88000
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Surrey Cancer Research Institute
Guildford, United Kingdom, GU2 7WG
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim Identifier: NCT01024920    
Other Study ID Numbers: 1199.26
2009-009516-44 ( EudraCT Number )
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action