RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe
NCT ID: NCT00688753
Last Updated: 2016-09-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2009-07-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RAD001
two 5 mg tablets of everolimus orally, once daily
RAD001
Interventions
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RAD001
Eligibility Criteria
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Inclusion Criteria
2. Patients with metastatic papillary renal cell carcinoma, type I or II.
3. Patients with at least one measurable lesion.
4. Patients with an ECOG Performance Status ≤1.
5. Adequate bone marrow function.
6. Adequate liver function.
7. Adequate renal function.
8. Adequate lipid profile.
Exclusion Criteria
2. Patients who have received prior systemic treatment for their metastatic RCC.
3. Patients who received prior therapy with VEGF pathway inhibitor.
4. Patients who have previously received systemic mTOR inhibitors.
5. Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.
6. Patients with uncontrolled central nervous system (CNS) metastases.
7. Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
8. Patients with a known history of HIV seropositivity.
9. Patients with autoimmune hepatitis.
10. Patients with an active, bleeding diathesis.
11. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
12. 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.
13. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
14. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
15. Patients unwilling to or unable to comply with the protocol.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Ghent, , Belgium
Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Villejuif, , France
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Münster, , Germany
Novartis Investigative Site
Arezzo, AR, Italy
Novartis Investigative Site
Cremona, CR, Italy
Novartis Investigative Site
Pavia, PV, Italy
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Otwock, , Poland
Novartis Investigative Site
Barcelona, Barcelona, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Countries
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References
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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.
Other Identifiers
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2008-006181-28
Identifier Type: -
Identifier Source: secondary_id
CRAD001LFR08
Identifier Type: -
Identifier Source: org_study_id
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