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Completed

NCT Number: NCT01801137

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

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

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Key information

Conditions

Urothelial Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital FOCH

Suresnes, Île-de-France Region, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus (Afinitor®)

Drug

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study 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

Acronym: AFINIVEST

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 28, 2013
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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