Urothelial CancerPhase 2AFINIVESTNCT01801137
The Efficacy of RAD 001 as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium
A Phase 2 study testing Everolimus (Afinitor®) in people with Urothelial Cancer, run by Hopital Foch at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Cancer
- What is being tested?
- Everolimus (Afinitor®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Urothelial Cancer
- Being tested
- Everolimus (Afinitor®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus (Afinitor®)Drug
| Study group | Role | What they receive |
|---|---|---|
| Afinitor | Experimental | Treatment by Afinitor 10 mg per day Receives: Drug: Everolimus (Afinitor®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startJun 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801137
- Sponsor's protocol ID
- 2010/23
- Acronym
- AFINIVEST
- Status last verified
- May 2016
- First submitted
- 12 Feb 2013
- Last updated
- 21 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01801137
- Acronym / sponsor ID
- AFINIVEST / 2010/23
- Conditions
- Urothelial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afinitor | Experimental | Drug: Everolimus (Afinitor®)Treatment by Afinitor 10 mg per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everolimus (Afinitor®) | Drug | Afinitor |
Primary outcome
Progression-free survival rate at 12 weeks
Time frame: 3 months
If a patient has not had an event, Progression-free survival is censored at the date of last adequate tumor assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Everolimus (Afinitor®) in people with Urothelial Cancer, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival rate at 12 weeks (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.