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Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01514448
First Posted: January 23, 2012
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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.

Condition Intervention Phase
Metastatic Renal Cell Carcinoma (mRCC) Drug: Everolimus (RAD001) Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Percentage of Progression-free Patients by Month 6 [ Time Frame: 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.


Secondary Outcome Measures:
  • Percentage of Patients With Overall Response Rate (ORR) Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy at Month 6 [ Time Frame: Month 6 ]
    Overall response rate (ORR) is the Percentage of patients with a best overall response of complete response (CR) or partial response (PR) by month 6. ORR was assessed according to RECIST 1.1 criteria. Partial response (PR) required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as reference the baseline sum of the longest diameters. Complete response (CR) required a disappearance of all target and non-target lesions.

  • 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 [ Time Frame: 24 months ]
    Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, progression-free survival was censored at the date of last adequate tumor assessment

  • Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months [ Time Frame: 48 months ]
    Overall survival (OS) was defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival will be censored at the date of last contact.

  • Duration of Response (DOR) in Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months [ Time Frame: 48 months ]
    The duration of overall response (DOR) was defined as the time from the first occurrence of a confirmed Complete Response (CR) or Partial Response (PR) (as per investigator assessment according to RECIST 1.1) until the date of the first documented disease progression or death due to underlying cancer. If a patient did not have an event or received any further anticancer therapy, duration of overall response was censored at the date of last adequate tumor assessment. Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated


Enrollment: 29
Actual Study Start Date: May 21, 2012
Study Completion Date: April 1, 2016
Primary Completion Date: April 1, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus
Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
Drug: Everolimus (RAD001)
Everolimus was used as commercially available formulated tablets of 10 mg strength
Other Name: RAD001

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514448


Locations
Germany
Novartis Investigative Site
Chemnitz, Germany, 09130
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Hannover, Germany, 30559
Novartis Investigative Site
Hof, Germany, 95028
Novartis Investigative Site
Kassel, Germany, 34125
Novartis Investigative Site
Langen, Germany, 63225
Novartis Investigative Site
Leipzig, Germany, 04357
Novartis Investigative Site
Magdeburg, Germany, 39120
Novartis Investigative Site
Muenster, Germany, 48149
Novartis Investigative Site
Ravensburg, Germany, 88214
Novartis Investigative Site
Velbert, Germany, 42551
Novartis Investigative Site
Wiesbaden, Germany, 65191
Novartis Investigative Site
Wolfsburg, Germany, 38440
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01514448     History of Changes
Other Study ID Numbers: CRAD001LDE43
2011-003416-23 ( EudraCT Number )
First Submitted: January 17, 2012
First Posted: January 23, 2012
Results First Submitted: March 31, 2017
Results First Posted: July 19, 2017
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Kidney cancer
mRCC
metastic renal cell carcinoma
everolimus
sunitinib
pazopanib

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors