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

Completed

• Conditions: Metastatic Renal Cell Carcinoma
• Interventions: Drug: Pazopanib

• Registration Number: NCT02282579
• Lead Sponsor: Spanish Oncology Genito-Urinary Group

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-10
• Study Start: 2014-10
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-04
• Primary Completion: 2015-02
• Study Completion: 2015-04
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with metastatic renal cell carcinoma treated	Pazopanib	Patient with metastatic renal cell carcinoma treated with Pazopanib

Primary Outcome Measures

Name	Time	Method
Describe the efficacy in terms of response	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).
Describe the efficacy in terms of progression-free survival (PFS)	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).
Describe the efficacy in terms of overall survival (OS)	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).

Trial Locations

Locations (34)

Hospital Provincial de Pontevedra; 🇪🇸 Pontevedra, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Vall d' Hebron; 🇪🇸 Barcelona, Spain

Hospital U Puerta de Hierro Majadahonda; 🇪🇸 Madrid, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital San Cecilio; 🇪🇸 Granada, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Son Espases; 🇪🇸 Palma De Mallorca, Mallorca, Spain

Hospital G U de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario de Donostia; 🇪🇸 Donostia, Spain

Hospital Clínico de Valencia; 🇪🇸 Valencia, Spain

Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Rio Hortega; 🇪🇸 Valladolid, Spain

CHUVI ( Vigo); 🇪🇸 Vigo, Spain

Hospital Marques de Valdecilla; 🇪🇸 Santander, Spain

Hospital Ntra. Sra. De Valme; 🇪🇸 Sevilla, Spain

Hospital Gral Universitario Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Dr. Peset; 🇪🇸 Valencia, Spain

IVO Valencia; 🇪🇸 Valencia, Spain

Hospital Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital San Pedro de Alcántara; 🇪🇸 Caceres, Spain

Hospital General Gran Canaria Dr. Negrín; 🇪🇸 Las Palmas de Gran Canaria, Spain

Hospital Reina Sofía; 🇪🇸 Cordoba, Spain

Hospital de León; 🇪🇸 León, Spain

Hospital San Pedro Logroño; 🇪🇸 Logroño, Spain

Hospital Lucus Augusti; 🇪🇸 Lugo, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Quirón; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario de Canarias; 🇪🇸 Santa Cruz de Tenerife, Spain