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

April 25, 2018 updated by: Spanish Oncology Genito-Urinary Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Clinic de Barcelona
      • Barcelona, Spain
        • Hospital Vall d' Hebron
      • Caceres, Spain
        • Hospital San Pedro de Alcantara
      • Ciudad Real, Spain
        • Hospital G U de Ciudad Real
      • Cordoba, Spain
        • Hospital Reina Sofia
      • Donostia, Spain
        • Hospital Universitario de Donostia
      • Granada, Spain
        • Hospital San Cecilio
      • Las Palmas de Gran Canaria, Spain
        • Hospital General Gran Canaria Dr. Negrín
      • León, Spain
        • Hospital de Leon
      • Logroño, Spain
        • Hospital San Pedro Logroño
      • Lugo, Spain
        • Hospital Lucus Augusti
      • Madrid, Spain
        • Fundacion Jimenez Diaz
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Quirón
      • Madrid, Spain
        • Hospital U Puerta de Hierro Majadahonda
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Pontevedra, Spain
        • Hospital Provincial de Pontevedra
      • Salamanca, Spain
        • Hospital Clinico Universitario Salamanca
      • Santa Cruz de Tenerife, Spain
        • Hospital Universitario de Canarias
      • Santander, Spain
        • Hospital Marques de Valdecilla
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocio
      • Sevilla, Spain
        • Hospital Ntra. Sra. De Valme
      • Toledo, Spain
        • Hospital Virgen De La Salud
      • Valencia, Spain
        • Hospital Clinico de Valencia
      • Valencia, Spain
        • Hospital Gral Universitario Valencia
      • Valencia, Spain
        • Hospital Universitario Dr. Peset
      • Valencia, Spain
        • IVO Valencia
      • Valladolid, Spain
        • Hospital Rio Hortega
      • Vigo, Spain
        • CHUVI ( Vigo)
      • Zaragoza, Spain
        • Hospital Lozano Blesa
      • Zaragoza, Spain
        • Hospital Miguel Servet
    • Mallorca
      • Palma De Mallorca, Mallorca, Spain
        • Hospital Son Espases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with metastatic renal cell carcinoma treated
Patient with metastatic renal cell carcinoma treated with Pazopanib
Drug: Pazopanib
Non interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the efficacy in terms of response
Time Frame: 3 years
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)
Time Frame: 3 years
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)
Time Frame: 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Oncology Genito-Urinary Group

Investigators

  • Principal Investigator: Jose Arranz, PhD, Investigator coordinator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

October 31, 2014

First Posted (Estimate)

November 4, 2014

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOG-SPA-2014-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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