The Efficacy of RAD 001 as Second Line Therapy in Patient... | NCT01801137

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

NCT01801137

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Jun 21, 2016Estimated

Enrollment

54Actual

Phase

Phase 2

Conditions

Urothelial Cancer

Interventions

Everolimus (Afinitor®)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Feb 12, 2013

First Submission Date that Met QC Criteria

Feb 26, 2013

First Posted Date

Feb 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2016

Last Update Posted Date

Jun 21, 2016Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Label	Type	Description	Intervention Names
Afinitor	Experimental	Treatment by Afinitor 10 mg per day	Drug: Everolimus (Afinitor®)

Name	Type	Description	Arm Group Labels	Other Names
Everolimus (Afinitor®)	Drug		Afinitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals