A study of the effectiveness and safety of the drug Pazopanib for use in patients with advanced kidney cancer who are suffering symptoms from their illness.

Active, not recruiting

Conditions: Clear cell renal cell carcinoma
MedDRA 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: EUCTR2011-001211-31-GB

Lead Sponsor: niversity of Birmingham

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 75

Inclusion Criteria

1) Written informed consent 2) Histologically confirmed diagnosis of renal cell carcinoma with clear cell component 3) Locally advanced (defined as not amenable of curative surgery) or metastatic disease 4) Measurable disease as per RECIST Criteria 1.1 5) Performance Status 2 assessed using the ECOG scale. 6) No prior systemic therapy 7) Female patients of childbearing potential will be eligible if they agree to adequate contraception. Pregnancy test must be negative 1 week before first drug dose 8) Adequate organ function as defined by the following criteria: o Total serum bilirubin =1.5 x ULN. Patients with Gilbert’s disease are eligible if the total; bilirubin is <3.0 x ULN and direct bilirubin is =35%. o Serum transaminases (AST and ALT) <2.5 x ULN, unless liver metastases are documented in which case AST and ALT must be = 5 x ULN oCalculated creatinine clearance =30mL/min (Cockroft Gault method) oUrine Protein to Creatinine Ratio (UPC) < 1. If UPC = 1 then a 24 hour urine protein must be assessed. Only patients with 24 hour urine protein < 1g will be eligible oTotal serum calcium concentration < 2.9 mmol/l oAbsolute neutrophil count (ANC) =1500/mm3 oHaemoglobin = 9g/dl oPlatelets = 100,000/mm3 oINR (International Normalised ratio) = 1.2 x ULN. Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range. 9) Age =18 10)Life expectancy = 12 weeks 11)Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1) Pregnant or lactating female patients. Patients who agree to discontinue nursing 14 days prior to commencing treatment and do not nurse throughout all the treatment period are eligible 2) Previous systemic treatment for RCC (licensed or investigational) including adjuvant or neo-adjuvant therapy 3) Major surgery or trauma < 4 weeks or radiotherapy and/or presence of any non-healing wound, fracture, or ulcer. Radiotherapy < 2 weeks prior to starting treatment 4) History or clinical evidence of brain metastases or active seizure disorders 5) Previous malignancies within the last 5 years, with the exception of successfully treated superficial or in situ carcinomas and of invasive tumours treated with curative intent and in remission for at least 5 years 6) Current use of drugs which are known strong CYP4A inhibitors (7.10) 7) Use of any prohibited medications within 14 days of the first dose of study medication (7.11) 8) Uncontrolled hypertension defined as systolic blood pressure = 150 mm Hg or diastolic blood pressure = 95 mm Hg. Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry 9) Presence of uncontrolled infection 10)Prolongation of the QT interval (QTc) > 480 msecs 11)History of malabsorption, major gastrointestinal tract resection or other pathology likely to affect study drug absorption 12)History of any one or more of the following cardiovascular conditions within the past 6 months: o Cardiac angioplasty or stenting o Myocardial infarction o Unstable angina o Coronary artery by-pass graft surgery o Symptomatic peripheral vascular disease o Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) Functional Classification 13)History of cerebrovascular accident (CVA) including transient ischemic attack (TIA) within the past 12 months 14)History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Patients with recent DVT who have been treated with therapeutic anticoagulating agents for at least 6 weeks are eligible 15)Evidence of active bleeding or bleeding diathesis 16)Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels 17)Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study 18)Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drug chemically related to pazopanib