Status:
COMPLETED
RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Carcinoma
Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- ≥ 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.
- Exclusion criteria:
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00688753
Start Date
July 1 2009
End Date
October 1 2014
Last Update
September 2 2016
Active Locations (19)
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1
Novartis Investigative Site
Brussels, Belgium, BE-B-1200
2
Novartis Investigative Site
Ghent, Belgium, 9000
3
Novartis Investigative Site
Bordeaux, France, 33075
4
Novartis Investigative Site
Lyon, France, 69373