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Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.

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ClinicalTrials.gov Identifier: NCT01024920
Recruitment Status : Active, not recruiting
First Posted : December 3, 2009
Last Update Posted : November 7, 2017
Information provided by (Responsible Party):

Study Description
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

Study Design

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 : August 15, 2018
Estimated Study Completion Date : August 15, 2018

Arms and Interventions

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

Outcome Measures

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 Frederica 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01024920

1199.26.3602 Boehringer Ingelheim Investigational Site
Pecs, Hungary
1199.26.4803 Boehringer Ingelheim Investigational Site
Lublin, Poland
1199.26.4804 Boehringer Ingelheim Investigational Site
Warszawa, Poland
1199.26.4001 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1199.26.4002 Boehringer Ingelheim Investigational Site
Craiova, Romania
1199.26.4003 Boehringer Ingelheim Investigational Site
Craiova, Romania
1199.26.3805 Boehringer Ingelheim Investigational Site
Cherkasy, Ukraine
1199.26.3807 Boehringer Ingelheim Investigational Site
Chernivtsi, Ukraine
1199.26.3802 Boehringer Ingelheim Investigational Site
Dnipropetrovks, Ukraine
1199.26.3801 Boehringer Ingelheim Investigational Site
Lviv, Ukraine
1199.26.3806 Boehringer Ingelheim Investigational Site
Uzhgorod, Ukraine
United Kingdom
1199.26.4401 Boehringer Ingelheim Investigational Site
Cambridge, United Kingdom
1199.26.4404 Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom
1199.26.4403 Boehringer Ingelheim Investigational Site
Guildford, United Kingdom
1199.26.4405 Boehringer Ingelheim Investigational Site
Leeds, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01024920     History of Changes
Other Study ID Numbers: 1199.26
2009-009516-44 ( EudraCT Number: EudraCT )
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action