Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib. - Full Text View

Purpose

Compare safety and efficacy of BIBF 1120 versus sunitinib.

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: BIBF 1120 Drug: sunitinib	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Progression Free Survival at 9 months. [ Time Frame: 9 months of treatment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression Free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Objective Response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Time to treatment failure. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Time to progression. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
BIBF 1120 patients only: Changes in QTcF [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Safety Endpoints all patients: Frequency of Adverse Events reported. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	99
Study Start Date:	December 2009
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Patients with unresectable or metastatic Renal Cell Cancer, who have received no previous systemic anti-cancer treatment.
Histological-confirmed diagnosis of renal cell cancer with clear cell component.
Acceptable renal,liver,cardiovascular,bone marrow and other functions to allow sunitinib/BIBF 1120 treatment.

Exclusion criteria:

Patients unable to tolerate Sunitinib/BIBF 1120 treatment
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.
Patients unable to comply with the 1199.26 protocol.
Pregnancy or breast feeding.
Active alcohol or drug abuse.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024920

Locations

Hungary
1199.26.3602 Boehringer Ingelheim Investigational Site
Pecs, Hungary
Poland
1199.26.4803 Boehringer Ingelheim Investigational Site
Lublin, Poland
1199.26.4804 Boehringer Ingelheim Investigational Site
Warszawa, Poland
Romania
1199.26.4001 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1199.26.4002 Boehringer Ingelheim Investigational Site
Craiova, Romania
Ukraine
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 Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01024920 History of Changes
Other Study ID Numbers:	1199.26, 2009-009516-44
Study First Received:	November 24, 2009
Last Updated:	May 15, 2013
Health Authority:	Hungary: National Institute of Pharmacy Poland: CEBK, Warsaw Romania: National Medicines Agency Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases

Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013