A randomized study to explore the efficacy and feasibility of rotations between sunitinib and everolimus versus sequential treatment of sunitinib and everolimus until progression in patients with renal cancer.
- Conditions
- Metastatic clear cell renal cancerMedDRA version: 14.1Level: LLTClassification code 10038416Term: Renal clear cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-001337-13-ES
- Lead Sponsor
- APRO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 115
-Renal cell carcinoma with a predominant clear cell component confirmed by histology or cytology
-Advanced disease: metastatic AND, not suitable for resection
-Male or female, aged 18 years or older
-ECOG 0 or 1
-Low or intermediate MSKCC prognostic risk score
-Target and/or non-target lesions according to RECIST 1.1
-Expected survival of at least 3 months.
-No prior systemic treatment.
-Adequate bone marrow function
-Adequate liver function
-Adequate renal function as shown by serum creatinine < 1.5 x ULN
-Left ventricular ejection fraction >55% on gated cardiac blood pool scan, or normal left ventricular function and fractional shortening on echocardiogram (according to institutional limits).
-Systolic blood pressure <140mmHg and diastolic blood pressure <90mmHg (it is acceptable to initiate antihypertensive treatment prior to registration to achieve these goals).
-Able to commence treatment within 7 days of registration.
-Willing and able to comply with follow-up and all other protocol requirements.
-Written informed consent
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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
-Prior treatment with VEGF-targeting agents or multi-kinase inhibitors or mTOR-targeting agents
-Active central nervous system metastases.
-Other malignancy diagnosed within the last 5 years, except the following if adequately treated: superficial squamous cell carcinoma or basal cell carcinoma of skin, superficial bladder cancer (T1 and G1 or T1 and G2), stage 1 cervical cancer.
-Treatment with an investigational agent in the last 4 weeks.
-Known to be HIV positive
-Evidence of chronic hepatitis due to HBV or HCV
-Clinically significant heart disease
-History of hypertension requiring hospitalization.
-Other serious illnesses, e.g. active infection requiring antibiotics, bleeding disorders.
-Immunotherapy or chemotherapy in the last 4 weeks
-Major surgery in the last 4 weeks, or planned in the next 6 weeks.
-Radiation therapy in the last 2 weeks, or planned in the next 6 weeks
-grade 3 or worse hemorrhage in last 4 weeks
-Any of the following in the last year: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
-Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
-Ongoing cardiac dysrhythmias grade >2, atrial fibrillation of any grade, or prolongation of the corrected QT interval (QTc) to >450 msec for males or >470 msec for females
-Uncontrolled diabetes as defined by fasting serum glucose >1.5 X ULN
-Pregnancy
-Known allergy or hypersensitivity to everolimus, sunitinib or iodine
-Medical or psychiatric condition that compromises the patients ability to give informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method