This trial is active, not recruiting.

Condition carcinoma, renal cell
Treatments bibf 1120, sunitinib
Phase phase 2
Sponsor Boehringer Ingelheim
Start date December 2009
End date August 2017
Trial size 99 participants
Trial identifier NCT01024920, 1199.26, 2009-009516-44


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Non-marketed substance: Twice daily oral doses of 200mg BIBF 1120 given continuously.
bibf 1120
VEGF inhibitor
(Active Comparator)
Marketed substance: Once a day oral doses of 50mg sunitinib given in repeated 6 week cycles: 4 weeks active, 2 weeks rest.
VEGF inhibitor

Primary Outcomes

Progression Free Survival at 9 months.
time frame: 9 months of treatment
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 Outcomes

Progression Free survival
time frame: 18 months
Objective Response
time frame: 36 months
Duration of Response
time frame: 36 months
Overall Survival
time frame: 36 months
Time to treatment failure.
time frame: 36 months
Time to progression.
time frame: 36 months
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
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
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

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.