The Efficacy of RAD 001 as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium

Phase 2

Completed

• Conditions: Urothelial Cancer
• Interventions: Drug: Everolimus (Afinitor®)

• Registration Number: NCT01801137
• Lead Sponsor: Hopital Foch

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 chemotherapy

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-28
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-06-20
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Afinitor	Everolimus (Afinitor®)	Treatment by Afinitor 10 mg per day

Primary Outcome Measures

Name	Time	Method
Progression-free survival rate at 12 weeks	3 months	If a patient has not had an event, Progression-free survival is censored at the date of last adequate tumor assessment.

Trial Locations

Locations (1)

Hôpital FOCH; 🇫🇷 Suresnes, Ile de France, France