Status:
COMPLETED
Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Metastatic Renal Cell Carcinoma (mRCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients with metastatic renal cell carcinoma (mRCC) who failed first-line therapy with sunitinib or pazopanib was treated with everolimus. Efficacy and safety of everolimus was evaluated in these pat...
Eligibility Criteria
Inclusion
- Patients with advanced renal cell carcinoma of a histological or cytological confirmation of clear cell renal carcinoma.
- Progression during or after a treatment with sunitinib or pazopanib given in a 1st line treatment situation for mRCC.
- Patients scheduled for treatment with everolimus.
- Patients with at least one measurable lesion at baseline as per RECIST v1.1.
Exclusion
- Patients who have received \>1 prior systemic treatment for their metastatic RCC. Prior systemic treatment in an adjuvant setting is allowed.
- Patients who have previously received systemic mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus).
- Patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start.
- Patients unwilling or unable to comply with the protocol.
Key Trial Info
Start Date :
May 21 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01514448
Start Date
May 21 2012
End Date
April 1 2016
Last Update
July 19 2017
Active Locations (13)
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1
Novartis Investigative Site
Chemnitz, Germany, 09130
2
Novartis Investigative Site
Dresden, Germany, 01307
3
Novartis Investigative Site
Hanover, Germany, 30559
4
Novartis Investigative Site
Hof, Germany, 95028