Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy

Metastatic Renal Cell Carcinoma Clinical Trial

— SPAZO  

Official title:

Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy, in Patients With Metastatic Renal Cell Carcinoma in Daily Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282579
• Other study ID #: SOG-SPA-2014-02
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

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