NCT01801137

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

June 21, 2016

Status Verified

May 1, 2016

Enrollment Period

3.3 years

First QC Date

February 12, 2013

Last Update Submit

June 20, 2016

Conditions

Urothelial Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Study Arms (1)

Afinitor

EXPERIMENTAL

Treatment by Afinitor 10 mg per day

Drug: Everolimus (Afinitor®)

Interventions

Everolimus (Afinitor®)DRUG
Afinitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital FOCH

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

Location

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 28, 2013

Study Start

June 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

June 21, 2016

Record last verified: 2016-05

Locations

FR(1)