EUCTR2010-020447-13-BG
Active, not recruiting
Not Applicable
An open-label, multicenter phase II study to examine the efficacy andsafety of everolimus as second-line therapy in the treatment of patientswith metastatic renal cell carcinoma - RECORD-4
ConditionsMetastatic 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]
DrugsAfinitor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic Renal Cell Carcinoma
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 201
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- 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.
Outcomes
Primary Outcomes
Not specified
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