Spots Global Cancer Trial Database for Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
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Trial Identification
Brief Title: Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
Official Title: A Retrospective, Multicenter Study of Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer Who Have Received Niraparib Within the Expanded Access Program (EAP) in Spain
Study ID: NCT04546373
Interventions
Study Description
Brief Summary: In April 2017, Tesaro, Inc. opened an expanded access program (EAP) to make niraparib, an investigational poly (ADP-ribose) polymerase (PARP) inhibitor, available to eligible women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following a complete or partial response to platinum-based chemotherapy, mainly for BRCA wild-type (BRCAwt) tumor patients, a clear unmet medical need for these ovarian cancer patients. As of 19 August 2019, the EAP closing date, there were 446 patients enrolled in 105 Spanish sites. All eligible deceased and consenting living patients at the participating centers will be included. Data will be directly retrieved from hospital medical records and reported in the electronic Case Report Form (eCRF). This study seeks to evaluate the safety profile and dose adjustments of niraparib in platinum sensitive recurrent ovarian cancer patients treated in a real world setting within the Spanish expanded access program (EAP).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Hospital Clínico Universitario de Santiago, Santiago De Compostela, A Coruña, Spain
Hospital Virgen de los Lirios, Alcoy, Alicante, Spain
Hospital Marina Baixa, Villajoyosa, Alicante, Spain
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Institut Català d'Oncología Badalona, Badalona, Barcelona, Spain
Hospital General de Granollers, Granollers, Barcelona, Spain
Institut Català d´ Oncologia-Hospital Duran y Reynals, L'Hospitalet De Llobregat, Barcelona, Spain
Consorci Sanitari de Terrassa, Rubí, Barcelona, Spain
Consorci Corporació Sanitària Parc Taulí de Sabadell, Sabadell, Barcelona, Spain
Hospital Universitario de Galdakao, Galdakao, Bizkaia, Spain
Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
Hospital Provincial de Castellón, Castelló de la Plana, Castellón, Spain
Hospital Universitario de Jerez, Jerez De La Frontera, Cádiz, Spain
Hospital Universitario Donostia, San Sebastián, Gipuzkoa, Spain
Hospital Universari Son Espases, Palma De Mallorca, Islas Baleares, Spain
Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
Hospital Universitario Infanta Sofia, San Sebastián De Los Reyes, Madrid, Spain
Hospital Álvaro Cunqueiro, Vigo, Pontevedra, Spain
Hospital Lluís Alcanyís de Xàtiva, Xàtiva, Valencia, Spain
Hospital Universitario de Basurto, Bilbao, Vizcaya, Spain
Complejo Hospitalario Universitario A Coruña (Juan Canalejo), A Coruña, , Spain
Hospital Universitari Sant Joan d'Alacant, Alicante, , Spain
Hospital Universitario Torrecárdenas, Almería, , Spain
Hospital del Mar, Barcelona, , Spain
Clínica Corachan, Barcelona, , Spain
Hospital Universitari Dexeus - Grupo Quirónsalud, Barcelona, , Spain
Hospital Clínic i Provincial de Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital San Pedro de Alcántara, Cáceres, , Spain
Hospital Universitario Puerta del Mar, Cádiz, , Spain
Hospital Universitario Reina Sofía, Córdoba, , Spain
Hospital Universitario Clínico San Cecilio, Granada, , Spain
Hospital Universitario de Guadalajara, Guadalajara, , Spain
Hospital General San Jorge, Huesca, , Spain
Complejo Hospitalario de Jaén - Hospital Médico-Quirúrgico, Jaén, , Spain
Hospital Universitari Arnau de Vilanova, Lleida, , Spain
Hospital Universitario de La Princesa, Madrid, , Spain
Clínica Universidad de Navarra, Madrid, , Spain
MD Anderson Cancer Center Madrid, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Universitario 12 De Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Complejo Hospitalario Universitario de Pontevedra (Hospital Montecelo), Pontevedra, , Spain
Hospital Clínico Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz De Tenerife, , Spain
Hospital Quirónsalud Sagrado Corazón, Sevilla, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Universitario de Valme, Sevilla, , Spain
Consorcio Hospital General Universitario de Valencia, Valencia, , Spain
Hospital Universitario Doctor Peset, Valencia, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Hospital Clínico Universitario de Valladolid, Valladolid, , Spain
Hospital Clínico Universitario Lozano Blesa, Zaragoza, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Contact Details
Name: Juan F. Cueva Bañuelos, Dr.
Affiliation: Complejo Hospitalario Universitario de Santiago de Compostela
Role: PRINCIPAL_INVESTIGATOR
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