Phase I Study With Sorafenib in Addition to Vinflunine in Metastatic Transitional Cell Carcinoma of the Urothelial Tract

Summary

This study aims to analyse the tolerability (side effects and safety) with standard treatment (Javlor®) with the addition of a second anti-tumour drug: sorafenib (Nexavar®). This is the first time this treatment combination is studied in humans. Samples of blood, urine and tumour tissues will be analysed for molecular biomarkers. These biomarkers may potentially help us in the future in predicting whether a patient will benefit or not from the cancer treatment. The study also aims to investigate if a newer imaging method, called PET-CT (positron emission tomography-computed tomography), at an earlier stage (than a normal CT scan) can identify patients who will benefit from the given treatment.

Timeline

Start

2012-05

Primary completion

2017-10-18

Completion

2018-06-05

Publications

• Shah CH, Pappot H, Agerbaek M, Holmsten K, Jaderling F, Yachnin J, Gryback P, von der Maase H, Ullen A. Safety and Activity of Sorafenib in Addition to Vinflunine in Post-Platinum Metastatic Urothelial Carcinoma (Vinsor): Phase I Trial. Oncologist. 2019 Jun;24(6):745-e213. doi: 10.1634/theoncologist.2018-0795. Epub 2018 Dec 14.

Drugs

Indications