Everolimus as Second-line Therapy in Metastatic Renal Cell Carcinoma

Completed · Phase 2

Conditions studied: Metastatic Renal Cell Carcinoma

In brief

This study will evaluate everolimus as second-line therapy in patients with metastatic renal cell carcinoma. Each patient will be enrolled and stratified in one of three cohorts based upon their first-line therapy: 1) prior cytokines, 2) prior sunitinib, or 3) prior anti-VEGF therapy other than sunitinib.

Key facts

Study ID

NCT01491672

Run by

Novartis Pharmaceuticals

People needed

134

Starts

2011-11-01

Expected to finish

2015-05-01

Last updated by the study team

2016-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old.
• Patients with 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 first-line therapy with sunitinib, sorafenib, pazopanib, axitinib, bevacizumab, or cytokine therapy.
• Patients must have had prior nephrectomy (partial or total).
• Patients with at least one measurable lesion at baseline as per the RECIST 1.0 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.
• Patients with a Karnofsky Performance Status ≥ 70%.
• Adequate bone marrow function as shown by:
• ANC ≥ 1.5 x 109/L,
• Platelets ≥ 100 x 109/L,
• Hemoglobin >9 g/dL
• Adequate liver function as shown by:
• Serum bilirubin ≤ 1.5 x ULN,
• ALT and AST ≤ 2.5 x ULN. Patients with known liver metastases may enroll if their AST and ALT ≤ 5 x ULN,
• INR < 1.3 (INR < 3 in patients treated with anticoagulants)
• Adequate renal function: serum creatinine ≤ 2.0 x ULN.
• Fasting serum cholesterol ≤300 mg/dl OR ≤7.75 mmol/L AND fasting triglycerides ≤2.5 x ULN.
• Written informed consent obtained before any trial related activity and according to local guidelines.

You may not qualify if…

• Patients with brain metastases.
• Patients within 4 weeks post-major surgery (e.g., intra-thoracic, intra-abdominal or intrapelvic), 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.
• Patients in anticipation of the need for major surgical procedure during the course of the study.
• 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).
• Patients with a serious non-healing wound, ulcer, or bone fracture.
• Patients with a history of seizure(s) not controlled with standard medical therapy.
• Patients who have received more than one prior treatment regimen for metastatic renalcell carcinoma
• Patients who have received adjuvant therapy for RCC
• Patients who have previously received systemic mTOR inhibitors (eg, sirolimus, temsirolimus, everolimus)
• Patients with a known hypersensitivity to everolimus or other rapamycins (eg, sirolimus, temsirolimus) or to its excipients.
• History or clinical evidence of central nervous system (CNS) metastases.
• Clinically significant gastrointestinal abnormalities including, but not limited to:
• Malabsorption syndrome:
• Major resection of the stomach or small bowel that could affect the absorption of study drug
• Active peptic ulcer disease
• Inflammatory bowel disease:
• i. Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation ii. History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
• Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline is not required.
• Active bleeding diathesis
• Uncontrolled diabetes mellitus as defined by fasting serum glucose > 2.0 x ULN.
• Patients who have any severe and/or uncontrolled medical conditions such as:
• unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction
• ≤ 6 months prior to enrollment, serious uncontrolled cardiac arrhythmia,
• active or uncontrolled severe infection,

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Novartis Investigative Site — San Miguel de Tucumán, Tucumán Province, Argentina
• Novartis Investigative Site — Rio Negro, Viedma, Argentina
• Novartis Investigative Site — Florianópolis, Santa Catarina, Brazil
• Novartis Investigative Site — Barretos, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Sofia, Bulgaria
• Novartis Investigative Site — Beijing, Beijing Municipality, China
• Novartis Investigative Site — Hangzhou, Zhejiang, China
• Novartis Investigative Site — Beijing, China
• Novartis Investigative Site — Guangzhou, China
• Novartis Investigative Site — Shanghai, China
• Novartis Investigative Site — Leningrad Region, Russia, Russia
• Novartis Investigative Site — Moscow, Russia, Russia
• Novartis Investigative Site — Nizhny Novgorod, Russia, Russia
• Novartis Investigative Site — Obninsk, Russia, Russia

Full record on ClinicalTrials.gov

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