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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Clínic 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 Marqués 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spanish Oncology Genito-Urinary Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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