Conditions: Carcinoma, Renal Cell
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 99
Healthy volunteers: no

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).

Detailed description:

Arms:
arm 1: Non-marketed substance: Twice daily oral doses of 200mg BIBF 1120 given continuously. arm 2: Marketed substance: Once a day oral doses of 50mg sunitinib given in repeated 6 week cycles: 4 weeks active, 2 weeks rest.

Interventions: intervention 1: BIBF 1120 intervention 2: sunitinib
Intervention descriptions: intervention 1: VEGF inhibitor intervention 2: VEGF inhibitor

Protocol document: