Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib
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
2 other identifiers
interventional
29
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2012
Longer than P75 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2012
CompletedFirst Posted
Study publicly available on registry
January 23, 2012
CompletedStudy Start
First participant enrolled
May 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
July 19, 2017
CompletedJuly 19, 2017
July 1, 2017
3.9 years
January 17, 2012
March 31, 2017
July 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Progression-free Patients by Month 6
Percentage of progression-free patients by month 6 after starting everolimus treatment. For the purpose of the binomial design of the study, a patient being 'progression-free' will be defined as a patient without disease progression by month 6 whereas a subject with progressive disease by month 6 will not be counted as 'progression-free'. The primary variable was derived from radiologic tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) Disease progression was either 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline (minimum absolute increase 5 mm in sum) or 2) the appearance of a new lesion or 3) the unequivocal progression of non-target lesions overall.
Month 6
Secondary Outcomes (4)
Percentage of Patients With Overall Response Rate (ORR) Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy at Month 6
Month 6
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
24 months
Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months
48 months
Duration of Response (DOR) in Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months
48 months
Study Arms (1)
Everolimus
EXPERIMENTALEverolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
Interventions
Everolimus was used as commercially available formulated tablets of 10 mg strength
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Novartis Investigative Site
Chemnitz, 09130, Germany
Novartis Investigative Site
Dresden, 01307, Germany
Novartis Investigative Site
Hanover, 30559, Germany
Novartis Investigative Site
Hof, 95028, Germany
Novartis Investigative Site
Kassel, 34125, Germany
Novartis Investigative Site
Langen, 63225, Germany
Novartis Investigative Site
Leipzig, 04357, Germany
Novartis Investigative Site
Magdeburg, 39120, Germany
Novartis Investigative Site
Münster, 48149, Germany
Novartis Investigative Site
Ravensburg, 88214, Germany
Novartis Investigative Site
Velbert, 42551, Germany
Novartis Investigative Site
Wiesbaden, 65191, Germany
Novartis Investigative Site
Wolfsburg, 38440, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2012
First Posted
January 23, 2012
Study Start
May 21, 2012
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
July 19, 2017
Results First Posted
July 19, 2017
Record last verified: 2017-07