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

Urothelial Cancer Clinical Trial

— AFINIVEST  

Official title:

A Multicentre Phase III Trial to Determine the Efficacy of RAD 001 (Everolimus, Afinitor) as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium Which Failed or Progressed After First Line Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801137
• Other study ID #: 2010/23
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2013
• Last updated: June 20, 2016
• Start date: June 2011
• Est. completion date: October 2014

Study information

• Verified date: May 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Urothelial Cancer

Intervention

Drug:
• Everolimus (Afinitor®)

Locations

Country	Name	City	State
France	Hôpital FOCH	Suresnes	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival rate at 12 weeks	If a patient has not had an event, Progression-free survival is censored at the date of last adequate tumor assessment.	3 months	Yes