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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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01514448
First received: January 17, 2012
Last updated: July 17, 2017
Last verified: July 2017
January 17, 2012
July 17, 2017
May 21, 2012
April 1, 2016   (Final data collection date for primary outcome measure)
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.
Rate of patients progression-free after 6 months of treatment [ Time Frame: 6 months ]
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.
Complete list of historical versions of study NCT01514448 on ClinicalTrials.gov Archive Site
  • 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
  • Progression-free survival as the time interval between first intake of everolimus and first documented disease progression or death due to any cause [ Time Frame: Baseline, Every 3 months ]
    Progression-free survival 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 has not had an event, progression-free survival is censored at the date of last adequate tumor assessment
  • Overall survival of patients treated with everolimus after failure of first-line sunitinib or pazopanib therapy [ Time Frame: Baseline, every 28 days ]
    Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact.
  • Overall response rate in patients treated with everolimus after failure of first-line sunitinib or pazopanib therapy [ Time Frame: Baseline, every 3 months ]
    Investigator's best overall response rate (ORR) is the proportion of patients with a best overall response of complete response (CR) or partial response (PR) by month 6. ORR will be assessed according to RECIST 1.1 criteria.
  • Duration of response in patients treated with everolimus after failure of first-line sunitinib or pazopanib therapy [ Time Frame: Baseline, Every 3 months ]
    The duration of overall response (CR or PR) is defined as the time from the first occurrence of a confirmed CR or 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 has not had an event or when they receive any further anticancer therapy, duration of overall response is censored at the date of last adequate tumor assessment. Duration of response will be displayed only for patients whose best overall response was CR or PR
  • Safety of everolimus after failure of first-line sunitinib or pazopanib therapy [ Time Frame: Baseline, Every 28 days ]
    The assessment of safety will be based mainly on frequency of adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g., electrocardiogram, vital signs) will be considered as appropriate. All safety data will be listed. The safety summary tables will only include assessments collected no later than 28 days after study treatment discontinuation. All safety assessments will be listed and those collected later than 28 days after study treatment discontinuation will be flagged.
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Renal Cell Carcinoma (mRCC)
Drug: Everolimus (RAD001)
Everolimus was used as commercially available formulated tablets of 10 mg strength
Other Name: RAD001
Experimental: Everolimus
Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
Intervention: Drug: Everolimus (RAD001)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
April 1, 2016
April 1, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01514448
CRAD001LDE43
2011-003416-23 ( EudraCT Number )
No
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP