Trial to Evaluate Paclitaxel Plus RAD001 in Urothelial Carcinoma
NCT00933374 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2015-03-18
Summary
This is a single arm open- label phase II- trial evaluating safety and efficacy of paclitaxel and RAD001 in patients with metastatic urothelial bladder cancer who failed prior platin-based systemic therapy.
Conditions
Interventions
- DRUG
-
Paclitaxel (175 mg/m3)will be administered as a 3 hour continuous IV infusion after standard premedication every 3 weeks
- DRUG
-
RAD001
10 mg RAD001 once daily starting at day 1 of a 21 days treatment cycle
Sponsors & Collaborators
-
Heinrich-Heine University, Duesseldorf
lead OTHER
Principal Investigators
-
Peter Albers, Professor · Heinrich-Heine-University, Department of Urology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-07-31
- Primary Completion
- 2013-01-31
- Completion
- 2013-09-30
Countries
- Germany
Study Locations
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