An Open Label, Single Arm Trial to Evaluate Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of First Line Therapy With Sunitinib or Pazopanib
18 Years
N/A
Both
Metastatic Renal Cell Carcinoma (mRCC)
Trial Information
An Open Label, Single Arm Trial to Evaluate Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of First Line Therapy With Sunitinib or Pazopanib
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Other protocol-defined inclusion/exclusion criteria may apply.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of patients progression-free after 6 months of treatment
Outcome Description:
Primary endpoint is proportion of patients progression-free by month 6 after starting everolimus treatment. A 'responder' will be defined as a subject without progression by month 6 whereas a 'non-responder' will be defined as a subject with progressive disease by month 6. The primary variable will be derived from radiologic tumor assessments according to RECIST 1.1.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CRAD001LDE43
NCT ID:
NCT01514448
Start Date:
May 2012
Completion Date:
September 2015
Related Keywords:
- Metastatic Renal Cell Carcinoma (mRCC)
- Kidney cancer
- mRCC
- metastic renal cell carcinoma
- everolimus
- sunitinib
- pazopanib
- Carcinoma
- Carcinoma, Renal Cell
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