Completed

AFINIVESTEverolimus (Afinitor) Efficacy in Transitional Cell Carcinoma After Failed Chemotherapy

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Study Aim

This study aims to evaluate the effectiveness of Everolimus (Afinitor) in treating Transitional Cell Carcinoma in patients who have not responded well to previous chemotherapy, by observing the progression-free survival rate at 12 weeks.

What is being tested

Using Everolimus (Afinitor®) for Treatment

Drug
Who is being recruted

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2011
See protocol details

Summary

Principal SponsorHopital Foch
Last updated: June 21, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2011

Actual date on which the first participant was enrolled.

This is a study focused on the treatment of transitional cell carcinoma of the urothelium, a type of cancer that affects the lining of the urinary system. The study is specifically for patients who have not responded well to two previous lines of chemotherapy. The main goal is to evaluate the effectiveness of a drug called Everolimus, also known as Afinitor®, as a third line of therapy. The importance of this study lies in its potential to provide an alternative treatment option for patients who have not benefited from initial treatments, addressing a significant unmet need in cancer care.

NCT01801137
Principal SponsorHopital Foch
Last updated: June 21, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

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

54 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate
Histologically proven transitional cell carcinoma of the urothelium
Male or female aged more than 18 years
Measurable disease (RECIST criteria)
Metastatic or locally advanced disease not amenable to curative surgery and/or radiotherapy
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5 exclusion criteria prevent from participating
No currently active CNS involvement
No pregnancy. Women of child bearing potential must have a negative pregnancy test
No prior treatment with anti cancer agents, including radiotherapy, in the last 4 weeks
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Treatment by Afinitor 10 mg per day

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hôpital FOCH

Suresnes, FranceOpen Hôpital FOCH in Google Maps
CompletedOne Study Center