Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
- Conditions
- Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer
- Registration Number
- NCT04546373
- Lead Sponsor
- Grupo Español de Investigación en Cáncer de Ovario
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 316
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Female participants 18 years old or older.
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Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
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Participant must have received niraparib within the Spanish expanded access program (EAP).
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Patients must have received at least 1 week of treatment with niraparib.
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Histological diagnosis of high grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
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Participants must have completed at least 2 previous courses of platinum-containing therapy (e.g., carboplatin, oxaliplatin, or cisplatin).
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For the penultimate (next to last) platinum-based chemotherapy course prior to enrolment on the program the patient must have platinum sensitive disease after this treatment; defined as achieving a response (complete response (CR) or partial response (PR)) and disease progression occurring no sooner than 6 months, after completion of the last dose of platinum chemotherapy.
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For the last chemotherapy course prior to inclusion in the program the patient must have received a platinum-containing regimen for a minimum of 4 cycles.
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For the last chemotherapy course prior to inclusion in the program the Patient must have achieved a partial (PR) or complete (CR) tumor response.
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The last platinum regimen does not necessarily have to immediately follow the next to last (penultimate) platinum regimen. For example, if a patient received a non-platinum regimen between the penultimate platinum regimen and last platinum regimen, they could be eligible, so long as they meet all entry criteria.
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When entering the EAP, patients must have met the following:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Adequate organ function - Absolute neutrophil count (ANC) ≥ (greater than or equal to) 1,500/μL.
- Adequate organ function - Platelets ≥ (greater than or equal to) 100,000/μL.
- Adequate organ function - Hemoglobin ≥ (greater than or equal to) 9 g/dL.
- No transfusions of erythrocytes or platelets within 2 weeks prior to assessing adequate hematological blood counts as listed above.
- Patients without medical record available (lost, empty or unretrievable clinical information).
- Patients who decline consent.
- Patients who are deceased with prior express order to preserve their data.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Demographics Month 4-6 Medical History Month 4-6 Ovarian Cancer Diagnosis Month 4-6 Ovarian Cancer Treatments (pre-Niraparib) Month 4-6 Baseline (pre-Niraparib) Month 4-6 Niraparib Treatment Month 4-6 Niraparib Disease Progression Month 4-6 Best Response Assessment Month 4-6 Niraparib-Related Adverse Events Month 4-6 Relevant Concomitant Medications Month 4-6 Death Month 4-6 Survival Status Month 4-6 Subsequent Therapies for Ovarian Cancer Month 4-6
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (57)
Hospital Universitari Dexeus - Grupo Quirónsalud
🇪🇸Barcelona, Spain
Institut Català d´ Oncologia-Hospital Duran y Reynals
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Virgen de los Lirios
🇪🇸Alcoy, Alicante, Spain
Hospital General de Granollers
🇪🇸Granollers, Barcelona, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Clínica Corachan
🇪🇸Barcelona, Spain
Complejo Hospitalario Universitario A Coruña (Juan Canalejo)
🇪🇸A Coruña, Spain
Hospital Universitari Sant Joan d'Alacant
🇪🇸Alicante, Spain
Hospital Universitario Clínico San Cecilio
🇪🇸Granada, Spain
Hospital Lluís Alcanyís de Xàtiva
🇪🇸Xàtiva, Valencia, Spain
Clínica Universidad de Navarra
🇪🇸Madrid, Spain
Hospital Quirónsalud Sagrado Corazón
🇪🇸Sevilla, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario HM Sanchinarro
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Universitario de Galdakao
🇪🇸Galdakao, Bizkaia, Spain
Hospital Universitario de Jerez
🇪🇸Jerez De La Frontera, Cádiz, Spain
Hospital Provincial de Castellón
🇪🇸Castelló de la Plana, Castellón, Spain
Hospital Marina Baixa
🇪🇸Villajoyosa, Alicante, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Hospital Universitario Donostia
🇪🇸San Sebastián, Gipuzkoa, Spain
Consorci Sanitari de Terrassa
🇪🇸Rubí, Barcelona, Spain
Hospital Clínic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital General San Jorge
🇪🇸Huesca, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
MD Anderson Cancer Center Madrid
🇪🇸Madrid, Spain
Hospital Universitari Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario 12 De Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Doctor Peset
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Hospital Universitario de Valme
🇪🇸Sevilla, Spain
Hospital Universitario de Guadalajara
🇪🇸Guadalajara, Spain
Hospital Clínico Universitario de Santiago
🇪🇸Santiago De Compostela, A Coruña, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Institut Català d'Oncología Badalona
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Universari Son Espases
🇪🇸Palma De Mallorca, Islas Baleares, Spain
Hospital Universitario Infanta Sofia
🇪🇸San Sebastián De Los Reyes, Madrid, Spain
Hospital Universitario Torrecárdenas
🇪🇸Almería, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario de Basurto
🇪🇸Bilbao, Vizcaya, Spain
Hospital Universitario Puerta del Mar
🇪🇸Cádiz, Spain
Hospital San Pedro de Alcántara
🇪🇸Cáceres, Spain
Complejo Hospitalario de Jaén - Hospital Médico-Quirúrgico
🇪🇸Jaén, Spain
Complejo Hospitalario Universitario de Pontevedra (Hospital Montecelo)
🇪🇸Pontevedra, Spain
Hospital Universitario Nuestra Señora de Candelaria
🇪🇸Santa Cruz De Tenerife, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Consorcio Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Consorci Corporació Sanitària Parc Taulí de Sabadell
🇪🇸Sabadell, Barcelona, Spain
Hospital Universitario Fundación Alcorcón
🇪🇸Alcorcón, Madrid, Spain