Metastatic clear cell renal cancer MedDRA version: 14.1 Level: LLT Classification code 10038416 Term: Renal clear cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: SUTENT
Product Name: SUTENT
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: SUNITINIB
CAS Number: 341031-54-7
Other descriptive name: SUNITINIB MALATE
Concentration unit: mg millig
Sponsors
APRO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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 55% on gated cardiac blood pool scan, or normal left ventricular function and fractional shortening on echocardiogram (according to institutional limits). -Systolic blood pressure =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression-free survival (PFS);Secondary Objective: a)PFS of sequential arm versus PFS of the 2 lines in control arm. b)Objective tumor response rate (ORR) per arm c)Overall Survival (OS) d)Safety Profile;Primary end point(s): Progression;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Progression b) Partial and Complete responses c) Survival d) Adverse events;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Greece, Spain
Contacts
Public ContactInma Musté
APRO
Outcome results
None listed