NCT00544609

Sorafenib and Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent

Phase I Trial of Sorafenib in Combination With Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Spanish Oncology Genito-Urinary Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Safety profile and to determine maximum tolerated dose of Sorafenib in combination with Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent

Detailed description

Study phase I in patients with Invasive Bladder Cancer

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Sorafenib	Level 1: 200 mg/day Level 2: 400mg/day Level 3: 800mg/day
PROCEDURE	Radiotherapy	3th-8th week: sorafenib daily with radiotherapy day 1, 2, 3, 4 and 5, 9th week: sorafenib daily with radiotherapy day 1 and 2

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-08-01
• Completion: 2012-05-01
• First posted: 2007-10-16
• Last updated: 2014-10-02

Locations

3 sites across 1 country: Spain