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

June 20, 2016 updated by: Hopital Foch

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Suresnes, Ile de France, France, 92150
        • Hôpital FOCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Afinitor
Treatment by Afinitor 10 mg per day
Drug: Everolimus (Afinitor®)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 12, 2013

First Submitted That Met QC Criteria

February 26, 2013

First Posted (Estimate)

February 28, 2013

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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