advanced or metastatic Renal Cell Carcinoma MedDRA version: 19.1 Level: LLT Classification code 10038415 Term: Renal cell carcinoma stage unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: PT Classification code 10067946 Term: Renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Votrient
Product Name: Votrient
Pharmaceutical Form: Film-coated tablet
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information regarding pazopanib that may impact patient treatment is found in the local product labeling. Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study. Therefore, adherence to the criteria as specified in the protocol is essential. Patients eligible for enrolment in the study must meet all of the following criteria: • Age = 18 years at enrollment • Documented diagnosis of advanced and/or metastatic clear cell or predominantly clear cell RCC • Clinical decision made to initiate treatment with pazopanib prior to enrollment in the study, but within 30 days of enrollment • Willing and able to provide 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 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Exclusion Criteria Deviations from exclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study. Therefore, adherence to the criteria as specified in the protocol is essential. Patients meeting any of the following criteria must not be enrolled in the study: • Patients currently participating in any interventional clinical trials in which treatment regimen and/or monitoring is dictated by a protocol • Previous exposure to an investigational or licensed multi-kinase inhibitor or an anti- VEGF angiogenesis inhibitor for advanced or metastatic disease (for guidance, refer to Appendix 1 located in the protocol). • Life expectancy < 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the PRINCIPAL study are: 1. To evaluate overall survival (OS), progression-free survival (PFS) and the overall response rate (ORR) in patients treated with pazopanib; 2. To characterise the relative dose intensity (RDI) and its observed effect on treatment outcomes; 3. To characterise the RCC patient population treated with pazopanib (e.g., by demographics, disease characteristics, previous RCC treatment history) in comparison to a selected clinical trial population; 4. To evaluate the change in health-related quality of life (HRQoL) relative to baseline in patients treated with pazopanib; and 5. To evaluate the frequency of serious adverse events (SAEs) and adverse events of special interest (AESIs) in patients treated with pazopanib.;Secondary Objective: The secondary objectives of the PRINCIPAL study are: 1. To evaluate clinical effectiveness, safety and RDI in those patients treated with pazopanib with comparable baseline characteristics to those included in the Phase III clinical trial [VEG105192]; 2. To evaluate clinical effectiveness, safety, RDI and HRQoL in relevant subgroups treated with pazopanib.;Primary end point(s): 1-PFS: defined as the interval between the date of first treatment with pazopanib and the earliest date of disease progression (by tumour response assessed by imaging or by clinical deterioration, whichever comes first) or death due to any cause OS: defined as the time from first treatment with pazopanib until death due to any cause ORR: defined as the percentage of patients with documented response (CR or PR) at any time during follow-up. 2-Study population distribution of RDI. 3-Study population distribution of baseline characteristics. 4-Change from baseline. 5-Any adverse event that results in a pazopanib dose modification or discontinuation Evidence of liver toxicity (e.g., increased ALT and/or AST, liver failure). New onset or worsened hypertension Cardiac dysfunction (e.g., decreased left v | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Outcome Measures: •Evaluate efficacy and safety comparable to VEG105192 [ Time Frame: Approximately 30 months ] To evaluate clinical effectiveness, safety and RDI in those patients with comparable baseline characteristics to those included in the Phase III clinical trial [VEG105192]. Endpoints: Same as primary effectiveness, safety and RDI objectives •Evaluate efficacy, safety, RDI, and HRQoL [ Time Frame: Approximately 30 months ] To evaluate clinical effectiveness, safety, RDI and HRQoL in relevant subgroups treated with pazopanib ;Timepoint(s) of evaluation of this end point: Secondary Outcome Measures: •Evaluate efficacy and safety comparable to VEG105192 [ Time Frame: Approximately 30 months ] To evaluate clinical effectiveness, safety and RDI in those patients with comparable baseline characteristics to those included in the Phase III clinical trial [VEG105192]. Endpoints: Same as primary effectiveness, safety and RDI objectives •Evaluate efficacy, safety, RDI, and HRQoL [ Time Frame: Approximately 30 months ] To evaluate clinical effectiveness, safety, RDI and HRQoL in relevant subgroups treated with pazopanib | — |
Countries
Argentina, Canada, Colombia, Finland, Pakistan, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma Services AG
Outcome results
None listed