Everolimus as Second-line Therapy in Metastatic Renal Cell Carcinoma
- Conditions
- Metastatic Renal Cell CarcinomaMedDRA version: 17.0Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-020447-13-BG
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 201
- Advanced renal cell carcinoma of a histological or cytological confirmation of clear cell (or with a component of clear cell) renal carcinoma that have previously progressed on or were intolerant to firstline therapy with sunitinib, sorafenib, pazopanib, axitinib, bevacizumab, or cytokine therapy
- Prior nephrectomy (partial or total)
- Patients with at least one measurable lesion at baseline as per the RECIST 1.0 criteria
- Karnofsky Performance Status = 70%
- Age = 18 years old
Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 101
- Patients who have received more than one prior treatment regimen for metastatic renal-cell carcinoma
- Patients who have received adjuvant therapy for RCC
- Patients who have previously received systemic mTOR inhibitors (eg, sirolimus, temsirolimus, everolimus)
- Patients with brain metastases
- Patients within 4 weeks post-major surgery, open biopsy, or significant traumatic injury to avoid wound healing complications.
- Patients who had radiation therapy within 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed up to 2 weeks prior to study treatment start).
- Concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the progression-free survival (PFS) in patients who receive<br>everolimus as second-line treatment for metastatic renal cell carcinoma;Secondary Objective: - To assess the safety profile of everolimus for the overall study<br>population as well as for each first-line treatment cohort<br>- To assess the progression-free survival (PFS) separately for each firstline treatment cohort<br>- To assess the overall survival (OS) for patients treated with secondline therapy with everolimus, as well as for each first-line treatment cohort<br>- To assess the clinical benefit rate and duration of response in patients who receive everolimus in second-line setting, as well as for each firstline treatment cohort;Primary end point(s): Progression-free survival in patients who receive everolimus as secondline treatment for metastatic renal cell carcinoma;Timepoint(s) of evaluation of this end point: every 8 weeks until the occurrence of documented disease progression<br>per RECIST 1.0
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1- Safety profile of everolimus for the overall study population as well as<br>for each first-line treatment cohort.<br>2- Progression-free survival separately for each first-line treatment<br>cohort<br>3- Overall survival<br>4- Clinical benefit rate<br>5- Objective response rate<br>6- Duration of response;Timepoint(s) of evaluation of this end point: 1- Continuously<br>2- Every 8 weeks until the occurrence of documented disease<br>progression per RECIST 1.0<br>3- Continuously<br>4- Every 8 weeks until the occurrence of documented disease<br>progression per RECIST 1.0<br>5- Every 8 weeks until the occurrence of documented disease<br>progression per RECIST 1.0<br>6- Every 8 weeks until the occurrence of documented disease<br>progression per RECIST 1.0