Phase I Study With Sorafenib in Addition to Vinflunine in Metastatic Transitional Cell Carcinoma of the Urothelial Tract
Status:
Completed
Trial end date:
2018-06-05
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Dr Anders Ullén
Collaborators:
Bayer Nordic Urothelial Cancer Oncology Group Pierre Fabre Laboratories