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

Primary Purpose

Urothelial Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Everolimus (Afinitor®)
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urothelial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital FOCH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Afinitor

Arm Description

Treatment by Afinitor 10 mg per day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 12, 2013
Last Updated
June 20, 2016
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT01801137
Brief Title
The Efficacy of RAD 001 as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Afinitor
Arm Type
Experimental
Arm Description
Treatment by Afinitor 10 mg per day
Intervention Type
Drug
Intervention Name(s)
Everolimus (Afinitor®)
Primary Outcome Measure Information:
Title
Progression-free survival rate at 12 weeks
Description
If a patient has not had an event, Progression-free survival is censored at the date of last adequate tumor assessment.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hôpital FOCH
City
Suresnes
State/Province
Ile de France
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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