Clinical trial NCT01514448: Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metastatic Renal Cell Carcinoma (mRCC)
Keywords: Kidney cancer
mRCC
metastic renal cell carcinoma
everolimus
sunitinib
pazopanib
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 patients.


Eligibility criteria: 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 as per RECIST v1.1.

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.

Primary outcomes:
measure: Percentage of Progression-free Patients by Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Patients With Overall Response Rate (ORR) Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy at Month 6
timeFrame: Month 6
measure: Progression-Free Survival (PFS) as the Time Interval Between First Intake of Everolimus and First Documented Disease Progression or Death Due to Any Cause at 24 Months
timeFrame: 24 months
measure: Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months
timeFrame: 48 months
measure: Duration of Response (DOR) in Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months
timeFrame: 48 months
Other outcomes:
Locations:
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Hof
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Langen
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Ravensburg
country: Germany
facility: Novartis Investigative Site
city: Velbert
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Wolfsburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: