Metastatic Renal Cell Carcinoma (mRCC)OSATNCT01390519
A Norwegian Observational Trial Evaluating the Treatment of Advanced Renal Cell Cancer Patients Under Treatment of Afinitor
An observational study of Metastatic Renal Cell Carcinoma (mRCC), run by Novartis Pharmaceuticals at 3 sites in Norway.
Trial summary
This is a Norwegian prospective registration, observational study of patients with advanced renal cell cancer on Afinitor treatment after failure of one Tyrosine Kinase Inhibitor (TKI) ( e.g. sunitinib or sorafenib). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma (mRCC)
- What is being tested?
- everolimis
- How many people
- 30 participants
- Where
- 3 sitesNorway
- Study dates
- Jun 2011to Dec 2015
- Phase
- Observational
- 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
Study population: Patients with advanced renal cell cancer whose disease has progressed on or after one VEGF-TKI therapy
Who may be able to join
- Age > 18 years
- Confirmed diagnosis of advanced renal cell cancer
- Progression on or after one VEGF -TKI (e.g. sunitibin, sorafenib)
- Written informed consent
Who cannot join
- None
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Novartis Investigative Site
Kristiansand, 4615
Novartis Investigative Site
Tromsø, 9038
Novartis Investigative Site
Trondheim, 7006
About this study
Official title: Observational Study Evaluating Efficacy, Tolerability and Treatment Algorithm of Advanced Renal Cell Cancer Patients Under Afinitor Treatment
This is a Norwegian prospective registration, observational study of patients with advanced renal cell cancer on Afinitor treatment after failure of one Tyrosine Kinase Inhibitor (TKI) ( e.g. sunitinib or sorafenib). The goal is to document the treatment algorithm of these patients in Norway and the efficacy and tolerability of Afinitor® in a pure 2.line setting.
- Conditions
- Metastatic Renal Cell Carcinoma (mRCC)
- Being tested
- everolimis
- Keywords
- mRCC,, observational,, Afinitor,, everolimus,, 2.line
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimisOther
Also called RAD001
| Study group | Role | What they receive |
|---|---|---|
| Afinitor | Afinitor Receives: Other: everolimis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression (TTP)
Measured: maximum of 12 months after inclusion of the last patient
Secondary outcomes (3)
Treatment algorithm
Follow up documentation
Measured: at end of study
Quality of life (QoL)(EORTC-QLQ C30)
Follow up documentation
Measured: maximum of 12 months after inclusion of the last patient
Tolerability
This will partly be assessed by registration of compliance (patient booklet), QoL and safety. Safety assessments will consist of monitoring and recording adverse events and serious adverse events.
Measured: maximum of 12 months after inclusion of the last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell Carcinoma (mRCC)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390519
- Sponsor's protocol ID
- CRAD001LNO03
- Acronym
- OSAT
- Status last verified
- Jan 2016
- First submitted
- 30 Jun 2011
- Last updated
- 13 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating Efficacy, Tolerability and Treatment Algorithm of Advanced Renal Cell Cancer Patients Under Afinitor Treatment
- ClinicalTrials.gov ID
- NCT01390519
- Acronym / sponsor ID
- OSAT / CRAD001LNO03
- Conditions
- Metastatic Renal Cell Carcinoma (mRCC)
- Keywords
- mRCC,, observational,, Afinitor,, everolimus,, 2.line
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Jul 2011 (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.
This is a Norwegian prospective registration, observational study of patients with advanced renal cell cancer on Afinitor treatment after failure of one Tyrosine Kinase Inhibitor (TKI) ( e.g. sunitinib or sorafenib). The goal is to document the treatment algorithm of these patients in Norway and the efficacy and tolerability of Afinitor® in a pure 2.line setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afinitor | – | Other: everolimisAfinitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced renal cell cancer whose disease has progressed on or after one VEGF-TKI therapy
Key inclusion criteria (4 listed)
- Age > 18 years
- Confirmed diagnosis of advanced renal cell cancer
- Progression on or after one VEGF -TKI (e.g. sunitibin, sorafenib)
- Written informed consent
Key exclusion criteria (2 listed)
- None
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| everolimisAlso: RAD001 | Other | Afinitor |
Primary outcome
Time to progression (TTP)
Time frame: maximum of 12 months after inclusion of the last patient
3 secondary outcomes
Treatment algorithm
Time frame: at end of study
Quality of life (QoL)(EORTC-QLQ C30)
Time frame: maximum of 12 months after inclusion of the last patient
Tolerability
Time frame: maximum of 12 months after inclusion of the last patient
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 13 Jan 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Carcinoma (mRCC), run by Novartis Pharmaceuticals at 3 sites in Norway.
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 4 inclusion and 2 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 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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.
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?
Time to progression (TTP) (time frame: maximum of 12 months after inclusion of the last patient). 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 13 Jan 2016.