An open-label, multicenter phase II study to compare the efficacy and safety of RAD001 as first-line followed by second-line sunitinib versus sunitinib as first-line followed by second-line RAD001 in the treatment of patients with metastatic renal cell carcinoma. - ND

• Conditions: metastatic renal cell carcinoma; MedDRA version: 9.1Level: LLTClassification code 10050513

• Registration Number: EUCTR2009-011056-21-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-04
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 427

Inclusion Criteria

1. Age ≥ 18 years old. 2. Patients with advanced renal cell carcinoma of a histological or cytological confirmation of clear cell (or with a component of clear cell) or patients with nonclear cell renal carcinoma. 3. Patients with nephrectomy (partial or total) or without nephrectomy. 4. Patients with at least one measurable lesion at baseline as per the RECIST criteria. If skin lesions are reported as target lesions, they should be documented(at baseline and at every physical exam) using color photography and a measuring device (such as a caliper) in clear focus to allow the size of the lesion(s) to be determined from the photograph. 5. Patients with a Karnofsky Performance Status ≥70%. 6. Adequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 100x 109/L, Hb >9 g/dL. 7. Adequate liver function: serum bilirubin: ≤ 1.5 x ULN, ALT and AST ≤ 2.5x ULN. Patients with known liver metastases: AST and ALT ≤ 5x ULN. 8. Adequate renal function: serum creatinine ≤ 2.0 x ULN. 9. Left ventricular ejection fraction (LVEF) ≥ lower limit of institutional normal (LLN)as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan. The same modality used at baseline should be applied for subsequent evaluations. 10. Women of childbearing potential must have had a negative serum pregnancy test within 14 days prior to the administration of the study medication. 11. Patients who give a written informed consent obtained according to local guidelines.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients within 4 weeks post-major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic), open biopsy, or significant traumatic injury to avoid wound healing complications. Minor procedures and percutaneous biopsies or placement of vascular access device require 7 days prior to study entry.2. Patients who had radiation therapy within 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed within 2 weeks prior to study treatment start).3. Patients in anticipation of the need for major surgical procedure during the course of the study.4. Patients with a serious non-healing wound, ulcer, or bone fracture.5. Patients with a history of seizure(s) not controlled with standard medical therapy.6. Patients who have received prior systemic treatment for their metastatic RCC. 7. Patients who have previously received systemic mTOR inhibitors (sirolimus, temsirolimus, everolimus) or VEGF inhibitors. 8. Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients.9. Patients with a known hypersensitivity to sunitinib or its excipients.10. History or clinical evidence of central nervous system (CNS) metastases. 11. Clinically significant gastrointestinal abnormalities.12. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥160mmHg or diastolic blood pressure (DBP) of ≥ 95mmHg]. Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry.13. Patients receiving chronic systemic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisone equivalent) or another immunosuppressive agent. Inhaled and topical steroids are acceptable.14. Patients with a known history of HIV seropositivity.15. Patients with active bleeding.16. Patients who have any severe and/or uncontrolled medical conditions or other conditions within the past 12 months that could affect their participation in the study.17. History of cerebrovascular accident (CVA) including transient ischemic attack (TIA) ≤ 6 months before start of study treatment.18. History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.19. Patients who have a history of another primary malignancy and off treatment for ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix or breast, and localized cancer of the bladder (T1) and prostate (T1 - T2).20. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Oral contraceptives are not acceptable.21. Patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start.22. Patients unwilling or unable to comply with the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified