CarcinomaPhase 2MACS0460NCT00688753
RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe
A Phase 2 study testing RAD001 in people with Carcinoma and Renal Cell, run by Novartis Pharmaceuticals at 19 sites in 6 countries.
Trial summary
To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Non Clear Cell Renal Carcinoma
- What is being tested?
- RAD001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 19 sitesin 6 countries
- Study dates
- Jul 2009to Oct 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- ≥ 18 years old.
- Patients with metastatic papillary renal cell carcinoma, type I or II.
- Patients with at least one measurable lesion.
- Patients with an ECOG Performance Status ≤1.
- Adequate bone marrow function.
- Adequate liver function.
- Adequate renal function.
- Adequate lipid profile.
Who cannot join
- Patients who had radiation therapy within 28 days prior to start of study.
- Patients who have received prior systemic treatment for their metastatic RCC.
- Patients who received prior therapy with VEGF pathway inhibitor.
- Patients who have previously received systemic mTOR inhibitors.
- Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.
- Patients with uncontrolled central nervous system (CNS) metastases.
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- Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
- Patients with a known history of HIV seropositivity.
- Patients with autoimmune hepatitis.
- Patients with an active, bleeding diathesis.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
- Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix.
- Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
- Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
- Patients unwilling to or unable to comply with the protocol.
Trial locations and contacts
19 sites in 6 countries.
19 sites in 6 countries
France5 sites
Novartis Investigative Site
Bordeaux, 33075
Novartis Investigative Site
Lyon, 69373
Novartis Investigative Site
Marseille, 13273
Novartis Investigative Site
Paris, 75015
Novartis Investigative Site
Villejuif, 94805
Italy4 sites
Novartis Investigative Site
Arezzo, AR, 52100
Novartis Investigative Site
Cremona, CR, 26100
Novartis Investigative Site
Naples, 80132
Novartis Investigative Site
Pavia, PV, 27100
Spain4 sites
Novartis Investigative Site
Barcelona, Barcelona, 08041
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08907
Novartis Investigative Site
Valencia, Valencia, 46009
Germany3 sites
Novartis Investigative Site
Berlin, 10098
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Münster, 48149
Belgium2 sites
Novartis Investigative Site
Brussels, BE-B-1200
Novartis Investigative Site
Ghent, 9000
About this study
Official title: A Single Arm, Multicenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Cancer
To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.
- Conditions
- Carcinoma, Renal Cell, Non Clear Cell Renal Carcinoma, Papillary Cell Renal Carcinoma, Adenocarcinoma
- Being tested
- RAD001
- Keywords
- renal cell carcinoma, non clear cell carcinoma, papillary cell renal carcinoma, adults, everolimus
- Medical subject headings
- Carcinoma, Carcinoma, Renal Cell, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001Drug
| Study group | Role | What they receive |
|---|---|---|
| RAD001 | Experimental | two 5 mg tablets of everolimus orally, once daily Receives: Drug: RAD001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.
PFSR at 6 months based on central review
Measured: 6 mos
Secondary outcomes (5)
Disease Control Rate (SD + PR + CR)
DCR was defined as the proportion of patients with a best overall response of CR, PR or SD and ORR as the percentage of patients with CR or PR
Measured: 6 mos
Objective Response Rate
ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. Response duration usually is measured from the time of initial response until documented tumor progression
Measured: End of trial
Duration of Response
The DOR analysis applied only to patients whose overall response was CR or PR and was defined as the time from onset of response (CR/PR) to progression or death from any cause.
Measured: End of trial
Median Progression Free Survival
PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause.
Measured: End of trial
Incidence of Adverse Events, Serious Adverse Events, and Death.
Measured: End of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startJul 2009
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CarcinomaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 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
- NCT00688753
- Sponsor's protocol ID
- CRAD001LFR08
- Other IDs
- 2008-006181-28, 2008
- Acronym
- MACS0460
- Status last verified
- Jul 2016
- First submitted
- 30 May 2008
- Last updated
- 2 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Escudier B, Molinie V, Bracarda S, Maroto P, Szczylik C, Nathan P, Negrier S, Weiss C, Porta C, Grunwald V, Albiges L. Open-label phase 2 trial of first-line everolimus monotherapy in patients with papillary metastatic renal cell carcinoma: RAPTOR final analysis. Eur J Cancer. 2016 Dec;69:226-235. doi: 10.1016/j.ejca.2016.08.004. Epub 2016 Sep 24.
PubMed 27680407
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Multicenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Cancer
- ClinicalTrials.gov ID
- NCT00688753
- Acronym / sponsor ID
- MACS0460 / CRAD001LFR08
- Conditions
- Carcinoma, Renal Cell, Non Clear Cell Renal Carcinoma, Papillary Cell Renal Carcinoma, Adenocarcinoma
- Keywords
- renal cell carcinoma, non clear cell carcinoma, papillary cell renal carcinoma, adults, everolimus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Posted 26 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAD001 | Experimental | Drug: RAD001two 5 mg tablets of everolimus orally, once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years old.
- Patients with metastatic papillary renal cell carcinoma, type I or II.
- Patients with at least one measurable lesion.
- Patients with an ECOG Performance Status ≤1.
- Adequate bone marrow function.
Key exclusion criteria (15 listed)
- Patients who had radiation therapy within 28 days prior to start of study.
- Patients who have received prior systemic treatment for their metastatic RCC.
- Patients who received prior therapy with VEGF pathway inhibitor.
- Patients who have previously received systemic mTOR inhibitors.
- Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.
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 |
|---|---|---|
| RAD001 | Drug | RAD001 |
Primary outcome
To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.
Time frame: 6 mos
PFSR at 6 months based on central review
5 secondary outcomes
Disease Control Rate (SD + PR + CR)
Time frame: 6 mos
Objective Response Rate
Time frame: End of trial
Duration of Response
Time frame: End of trial
Median Progression Free Survival
Time frame: End of trial
Incidence of Adverse Events, Serious Adverse Events, and Death.
Time frame: End of trial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27680407Escudier B, Molinie V, Bracarda S, Maroto P, Szczylik C, Nathan P, Negrier S, Weiss C, Porta C, Grunwald V, Albiges L. Open-label phase 2 trial of first-line everolimus monotherapy in patients with papillary metastatic renal cell carcinoma: RAPTOR final analysis. Eur J Cancer. 2016 Dec;69:226-235. doi: 10.1016/j.ejca.2016.08.004. Epub 2016 Sep 24.
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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
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RAD001 in people with Carcinoma and Renal Cell, run by Novartis Pharmaceuticals at 19 sites in 6 countries.
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 15 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 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Italy, Spain, Germany, Belgium and 1 more country. 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?
Yes. Results are posted in the registry (first posted 26 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months. (time frame: 6 mos). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00688753, which also lists 1 linked publication.
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 2 Sep 2016.