Status:
COMPLETED
The Efficacy of RAD 001 as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium
Lead Sponsor:
Hopital Foch
Conditions:
Urothelial Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A study to determine the efficacy of Everolimus(Afinitor®) as third line therapy in patients with transitional cell carcinoma of the urothelium which failed or progressed after two lines of chemothera...
Eligibility Criteria
Inclusion
- Provision of written informed consent
- Male or female aged more than 18 years
- Histologically proven transitional cell carcinoma of the urothelium
- Metastatic or locally advanced disease not amenable to curative surgery and/or radiotherapy
- Recurrence or progression after at least one chemotherapy regimen and for unresectable/advanced disease
- No more than 2 lines of previous chemotherapy..
- Measurable disease (RECIST criteria)
- Previously irradiated lesions are not considered measurable- ECOG performance status of 0, 1 or 2
Exclusion
- No prior treatment with anti cancer agents, including radiotherapy, in the last 4 weeks.
- No currently active CNS involvement
- No pregnancy. Women of child bearing potential must have a negative pregnancy test.
- No uncontrolled diabetes
- No symptomatic coronary artery disease, myocardial infarction within the last six months, congestive cardiac failure greater than New York Heart Association (NYHA) class II, uncontrolled or symptomatic cardiac arrhythmia
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01801137
Start Date
June 1 2011
End Date
October 1 2014
Last Update
June 21 2016
Active Locations (1)
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1
Hôpital FOCH
Suresnes, Île-de-France Region, France, 92150