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

Sponsor

Hopital Foch (Other)

Overall Status

Completed

CT.gov ID

NCT01801137

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Urothelial Cancer	Drug: Everolimus (Afinitor®)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Afinitor

Treatment by Afinitor 10 mg per day

Drug: Everolimus (Afinitor®)

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital FOCH	Suresnes	Ile de France	France	92150

Sponsors and Collaborators

Hopital Foch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hopital Foch

ClinicalTrials.gov Identifier:

NCT01801137

Other Study ID Numbers:

2010/23

First Posted:

Feb 28, 2013

Last Update Posted:

Jun 21, 2016

Last Verified:

May 1, 2016

Additional relevant MeSH terms:

Carcinoma, Transitional Cell

Everolimus

Study Results

No Results Posted as of Jun 21, 2016