Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01024920
First received: November 24, 2009
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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 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:


Further study details as provided by Boehringer Ingelheim:

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: Yes ]

Secondary Outcome Measures:
  • Progression Free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Objective Response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Time to treatment failure. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Time to progression. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • BIBF 1120 patients only: - New onset of QT/QTc>500ms - New onset of QTc>470ms - New onset of QTc>450ms [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 99
Study Start Date: December 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (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:

  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
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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
1199.26.4003 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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided by Boehringer Ingelheim

Additional 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
Study First Received: November 24, 2009
Last Updated: July 9, 2014
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 July 29, 2014