Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy
SPAZO
1 other identifier
observational
300
1 country
34
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
Shorter than P25 for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
November 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 26, 2018
April 1, 2018
4 months
September 10, 2014
April 25, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (1)
Patient with metastatic renal cell carcinoma treated
Patient with metastatic renal cell carcinoma treated with Pazopanib
Interventions
Eligibility Criteria
This study is aimed at patients who received pazopanib in first-line metastatic cell renal cancer, so care (clinical trial patients are excluded) in the period from April 2011 (date of approval of pazopanib in Spain) to 30 June 2014, ie, before the presentation of CEICs in each hospital. In all cases, any decision to administer pazopanib therapy in first line will be taken according to local clinical practice and prior to the inclusion of patients in this retrospective study.
You may qualify if:
- Patients ≥ 18.
- Metastatic renal cell cancer of any histology.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Hospital Son Espases
Palma de Mallorca, Mallorca, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Vall d' Hebron
Barcelona, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital G U de Ciudad Real
Ciudad Real, Spain
Hospital Reina Sofía
Córdoba, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, 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
Hospital Gregorio Marañon
Madrid, 28007, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Clínico San Carlos
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 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
Seville, Spain
Hospital Universitario Virgen del Rocío
Seville, 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, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Arranz, PhD
Investigator coordinator
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2014
First Posted
November 4, 2014
Study Start
October 1, 2014
Primary Completion
February 1, 2015
Study Completion
April 1, 2015
Last Updated
April 26, 2018
Record last verified: 2018-04