PRINCIPAL: A prospective observational study of real world treatment patterns and treatment outcomes in patients with advanced or metastatic renal cell carcinoma receiving pazopanib (115232)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29301
• EU PAS number:
  EUPAS6239
• Study ID:
  29301
• Official title and acronym:
  PRINCIPAL: A prospective observational study of real world treatment patterns and treatment outcomes in patients with advanced or metastatic renal cell carcinoma receiving pazopanib (115232)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study status:
  Finalised

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 02/03/2012

Actual: 02/03/2012

Study start date

Planned: 23/07/2012

Actual: 23/07/2012

Data analysis start date

Planned: 03/07/2017

Actual: 30/06/2017

Date of final study report

Planned: 30/06/2018

Actual: 11/05/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis

Study protocol

Initial protocol

veg115232-protocol-redacted

Updated protocol

veg115232-protocol-amend-redact

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)