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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02282579
Other study ID # SOG-SPA-2014-02
Secondary ID
Status Completed
Phase
First received September 10, 2014
Last updated April 25, 2018
Start date October 2014
Est. completion date April 2015

Study information

Verified date April 2018
Source Spanish Oncology Genito-Urinary Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this retrospective observational study was to analyze the effect of targeted therapies administered as second-line treatment after failure of pazopanib as well as increase the amount of information available on efficacy and safety of pazopanib as a first-line therapy in practice usual for the clinical treatment of metastatic Renal Carcinoma.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date April 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients = 18.

- Metastatic renal cell cancer of any histology.

- Patients treated with pazopanib for metastatic cell renal cancer outside the context of clinical trials (clinical practice) in Spanish centers from 1 April 2011 until 30 June 2014. shall be included all patients who received pazopanib as first-line treatment in each participating center, whether had experienced treatment failure with pazopanib or were still in first-line treatment. The inclusion of patients who are also allowed received cytokine as first-line treatment followed by pazopanib as well as patients who received sunitinib as first-line treatment and have changed pazopanib for toxicity or intolerance, provided they have not received more a cycle of sunitinib.

- Centers that agree to participate must commit to: · Include all patients meeting the inclusion criteria to reduce by possible selection bias. Because it supplies only pazopanib Hospital pharmacy service (not outside hospitals), the identification of patients will be performed at the hospital pharmacy records in each participating center.

Exclusion Criteria:

- Patients who received pazopanib in clinical trials or treatment second line, with the exceptions noted above.

- Patients with the diagnosis and / or treatment of malignancies of importance other than Cell renal cancer.

Study Design


Intervention

Drug:
Pazopanib
Non interventional study

Locations

Country Name City State
Spain Hospital Clínic de Barcelona Barcelona
Spain Hospital Vall d' Hebron Barcelona
Spain Hospital San Pedro de Alcántara Caceres
Spain Hospital G U de Ciudad Real Ciudad Real
Spain Hospital Reina Sofía Cordoba
Spain Hospital Universitario de Donostia Donostia
Spain Hospital San Cecilio Granada
Spain Hospital General Gran Canaria Dr. Negrín Las Palmas de Gran Canaria
Spain Hospital de León León
Spain Hospital San Pedro Logroño Logroño
Spain Hospital Lucus Augusti Lugo
Spain Fundacion Jimenez Diaz Madrid
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Gregorio Marañon Madrid
Spain Hospital Quirón Madrid
Spain Hospital U Puerta de Hierro Majadahonda Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Son Espases Palma De Mallorca Mallorca
Spain Hospital Provincial de Pontevedra Pontevedra
Spain Hospital Clínico Universitario Salamanca Salamanca
Spain Hospital Universitario de Canarias Santa Cruz de Tenerife
Spain Hospital Marques de Valdecilla Santander
Spain Hospital Ntra. Sra. De Valme Sevilla
Spain Hospital Universitario Virgen del Rocío Sevilla
Spain Hospital Virgen de la Salud Toledo
Spain Hospital Clínico de Valencia Valencia
Spain Hospital Gral Universitario Valencia Valencia
Spain Hospital Universitario Dr. Peset Valencia
Spain IVO Valencia Valencia
Spain Hospital Rio Hortega Valladolid
Spain CHUVI ( Vigo) Vigo
Spain Hospital Lozano Blesa Zaragoza
Spain Hospital Miguel Servet Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Spanish Oncology Genito-Urinary Group

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Describe the efficacy in terms of response Describe the efficacy in terms of response of second-line targeted therapies administered in patients with metastatic clear cell carcinoma treated pazopanib as a first-line therapy in routine clinical practice (unselected population). 3 years
Primary Describe the efficacy in terms of progression-free survival (PFS) Describe the efficacy in terms of progression-free survival (PFS) of second-line targeted therapies administered in patients with metastatic clear cell carcinoma treated pazopanib as a first-line therapy in routine clinical practice (unselected population). 3 years
Primary Describe the efficacy in terms of overall survival (OS) Describe the efficacy in terms of overall survival (PFS) of second-line targeted therapies administered in patients with metastatic clear cell carcinoma treated pazopanib as a first-line therapy in routine clinical practice (unselected population). 3 years
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