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

Phase 4

Completed

• Conditions: Metastatic Renal Cell Carcinoma (mRCC)
• Interventions: Drug: Everolimus (RAD001)

• Registration Number: NCT01514448
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Study Start: 2012-05-21
• Primary Completion: 2016-04-01
• Study Completion: 2016-04-01
• Results First Submitted: 2017-03-31
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-17
• Last Update Submitted: 2017-07-17
• Results First Posted: 2017-07-19
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Everolimus	Everolimus (RAD001)	Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.

Primary Outcome Measures

Name	Time	Method
Percentage of Progression-free Patients by Month 6	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

Name	Time	Method
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	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	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
Duration of Response (DOR) in Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months	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
Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Wolfsburg, Germany