Locally Advanced and/or Metastatic Renal Cell Carcinoma MedDRA version: 12.1 Level: LLT Classification code 10050513 Term: Metastatic renal cell carcinoma
Conditions
Interventions
Product Name: Pazopanib
Product Code: GW786034
Pharmaceutical Form: Over encapsulated tablet
INN or Proposed INN: Pazopanib
CAS Number: 635702-64-6
Current Sponsor code: GW786034B
Other descriptive na
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for enrolment in the study must meet all of the following criteria: 1.Patients must provide written informed consent prior to performance of any study-specific procedures or assessments and must be willing to comply with treatment and follow up. Procedures conducted as part of the patient’s routine clinical management (e.g. blood count, imaging study) and obtained prior to signing of informed consent may be utilised for screening or baseline purposes provided these procedures are conducted as specified in the protocol. 2.Received no prior systemic therapy (including interleukin-2, interferon-a, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC. Patients who received adjuvant treatment with a cancer vaccine are eligible. 3.Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic renal cell carcinoma of any histology (equivalent to Stage IV RCC according to AJCC staging). Patients with non-measurable disease are allowed if metastatic disease can be confirmed. 4.ECOG PS of 0 or 1 5.Age =18 years 6.A female is eligible to enter and participate in this study if she is of: Non-childbearing potential (i.e. physiologically incapable of becoming pregnant)Childbearing potential, including any female who has had a negative serum pregnancy test within two weeks prior to the first dose of study treatment, preferably as close to the first dose as possible and agrees to use adequate contraception (A list of GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are given in the appendix 11.4 of the protocol). 7.Adequate organ system functions as defined in Table 2 of the protocol. 8.Total serum calcium concentration =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Poor MSKCC risk group 2.History of another malignancy. Note: Patients who have had another malignancy and have been disease-free for 3 years or patients with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible. 3.History or clinical evidence of central nervous system (CNS) metastases. Note: Patients who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible: a.Are asymptomatic, b.Have had no evidence of active CNS metastases for =6 months prior to enrolment , c.Have no requirement for steroids or enzyme-inducing anticonvulsants (EIAC). 4.Any clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding or affect absorption of investigational product including, but not limited to: a.Malabsorption syndrome b.Major resection of the stomach or small bowel that could affect the absorption of study drug c.Active peptic ulcer disease d.Inflammatory bowel disease e.Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation f.History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment. 5.Presence of uncontrolled infection. 6.Corrected QT interval (QTc) >480 msecs using Bazett’s formula 7.History of one or more of the following cardiovascular conditions within the past 6 months: a.Cardiac angioplasty or stenting b.Myocardial infarction c.Unstable angina d.Coronary artery bypass graft surgery e.Symptomatic peripheral vascular disease f.Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) 8.Poorly controlled hypertension (defined as systolic blood pressure (SBP) of > 150mmHg or diastolic blood pressure (DBP) of > 90mmHg) at baseline. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour within a visit. The mean SBP/DBP values from each blood pressure assessment must be =150/90mmHg in order for a patient to be eligible for the study. 9.History of cerebrovascular accident (CVA) including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Patients with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible. 10.Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major). 11.Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels. 12.Evidence of active bleeding or bleeding diathesis. 13.Significant haemoptysis within 6 weeks prior to first dose of study drug. 14.Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient’s safety, obtaining informed consent or compliance to the study. 15.Use any prohibited medications within 14 days of the first dose of study medication. 16.Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug. 17.Radiation therapy, surgery or tumour embolisation within 14 da
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): •Patient preference (pazopanib vs. sunitinib) as assessed by patient preference questionnaire;Main Objective: To assess how the tolerability and safety differences between pazopanib and sunitinib translate into patient preference.;Secondary Objective: •To evaluate the reason for patient preference as assessed by a patient preference questionnaire •To evaluate fatigue as assessed by FACIT-Fatigue and quality of life as assessed by EuroQoL EQ-5D. •To evaluate dose modifications and time to dose modification •To evaluate the safety and tolerability (including AEs, SAEs, withdrawal of treatment due to AE, vital signs, ECG and clinical laboratory). | — |
Countries
Finland, Germany, Italy, United Kingdom
Outcome results
None listed