Clear cell renal cell carcinoma 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: Votrient
Product Name: pazopanib
Product Code: not applicable
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: pazopanib hydrochloride
CAS Number: 635702-64-6
Other descriptive
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of our clinical trial is to find out whether treatment with a drug called pazopanib is beneficial and safe for patients with advanced renal cancer and poor clinical condition (‘poor performance status’). These patients are often deemed not fit for treatment because of their poor prognosis and because of their perceived inability to withstand the side effects of the therapy. The treatments currently available cause severe side effects in two thirds of the patients and may require frequent hospital visits. By contrast pazopanib has demonstrated a significant efficacy and is well tolerated therefore it may represent a valuable treatment option for renal cancer patients with poor performance status. To assess treatment efficacy we will study in what percentage of patients pazopanib is able to prevent further tumour growth for at least 6 months; to assess safety we will study the ratio of patients who develop severe, drug induced, toxicity.;Secondary Objective: The secondary research objectives of our clinical trial are: i) To study the duration of survival from the start of the treatment with pazopanib until death of renal cancer patients with poor performance status (technically called ‘Overall Survival’). ii) To study the length of time over which pazopanib is able to block the growth of the renal cancer (technically called ‘Progression Free Survival’). iii) To study the ability of pazopanib to induce a shrinkage of the tumour mass (technically called ‘Response Rate’). iv) To study the entire profile of the side effects induced by pazopanib in the same group of patients. v) To study the differences between the drug dose actually administered compared with the planned dose.;Primary end point(s): 1) Tolerability - will be assessed as the proportion of patients who have not developed grade 3 or 4 clinically relevant and drug related adverse events within 6-months from the date of entry into the trial. Any adverse event to be cla | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival (PFS) will be measured at 12 months post registration as the number of whole days from the date of entry into trial until evidence of radiological disease progression or death by any cause, or censor date. Overall survival (OS) will be measured at 12 months post registration as the number of whole days from date of entry into the trial until death by any cause or censor. Response Rate will be defined as the proportion of patients who achieve either a complete or partial Radiological Response and Clinical benefit rate will be defined as the proportion of patients who achieve either a complete, partial or stable radiological response as defined by the RECIST 1.1 Criteria. Duration of response will be measured as the number of whole days between date of first evidence of response (CR or PR) until date of Progression of the Disease (PD) or death as defined by the RECIST 1.1 Criteria. Treatment safety is defined as the proportion of patients developing Adverse Events (AEs). Adverse Events will be collected from the date of entry in the trial until 28 days after drug discontinuation and graded according the NCI-CTC version 4. Adverse Events will be classified by causality, grade, type, duration and system involved. Drug dose administered will be defined by dose intensity, incidences of dose reductions, interruptions, escalations and discontinuations.;Timepoint(s) of evaluation of this end point: As above | — |
Countries
United Kingdom
Contacts
Public ContactBrendan Laverty
University of Birmingham
Outcome results
None listed