Multizentrische, randomisierte, doppelt verblindete, placebo-kontrollierte Phase I/II-Studie zur Prüfung der Wirksamkeit und Sicherheit von Nintedanib/Vargatef in Kombination mit Paclitaxel-Chemotherapie zur Behandlung von Patienten mit BRAF Wildtyp metastasiertem Melanom
Overall Study Design This is a multicenter, randomized, double-blind, placebo-controlled phase I/II trial designed to characterize the safety and to estimate the efficacy of nintedanib when combined with paclitaxel chemotherapy compared with paclitaxel chemotherapy alone in patients with BRAF wildtype metastatic melanoma not previously treated with taxanes or kinase inhibitors. In a preceding phase I of the study the optimum dosage of nintedanib (BIBF 1120) in combination with paclitaxel will be determined. See 5.1 for details. In phase II of the trial patients will be randomized to receive either nintedanib or placebo in combination with paclitaxel.
