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

Metastatic Renal Cell Carcinoma (mRCC) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514448
• Other study ID #: CRAD001LDE43
• Secondary ID: 2011-003416-23
• Status: Completed
• Phase: Phase 4
• First received: January 17, 2012
• Last updated: July 17, 2017
• Start date: May 21, 2012
• Est. completion date: April 1, 2016

Study information

• Verified date: July 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 1, 2016
• Est. primary completion date: April 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma (mRCC)

Intervention

Drug:
• Everolimus (RAD001)
Everolimus was used as commercially available formulated tablets of 10 mg strength

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hof
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Langen
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Ravensburg
Germany	Novartis Investigative Site	Velbert
Germany	Novartis Investigative Site	Wiesbaden
Germany	Novartis Investigative Site	Wolfsburg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Patients With Overall Response Rate (ORR) Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy at 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.	Month 6
Secondary	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	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	24 months
Secondary	Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 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.	48 months
Secondary	Duration of Response (DOR) in Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 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	48 months