Fallopian Tube Cancer Clinical Trial
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
NCT number | NCT04546373 |
Other study ID # | GEICO 88-R |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 30, 2020 |
Est. completion date | July 31, 2021 |
Verified date | August 2021 |
Source | Grupo Español de Investigación en Cáncer de Ovario |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 316 |
Est. completion date | July 31, 2021 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Female participants 18 years old or older. - Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent. - Participant must have received niraparib within the Spanish expanded access program (EAP). - Patients must have received at least 1 week of treatment with niraparib. - Histological diagnosis of high grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. - Participants must have completed at least 2 previous courses of platinum-containing therapy (e.g., carboplatin, oxaliplatin, or cisplatin). - 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. - 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. - For the last chemotherapy course prior to inclusion in the program the Patient must have achieved a partial (PR) or complete (CR) tumor response. - 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. - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Hospitalario Universitario A Coruña (Juan Canalejo) | A Coruña | |
Spain | Hospital Universitario Fundación Alcorcón | Alcorcón | Madrid |
Spain | Hospital Virgen de los Lirios | Alcoy | Alicante |
Spain | Hospital Universitari Sant Joan d'Alacant | Alicante | |
Spain | Hospital Universitario Torrecárdenas | Almería | |
Spain | Institut Català d'Oncología Badalona | Badalona | Barcelona |
Spain | Clínica Corachan | Barcelona | |
Spain | Hospital Clínic i Provincial de Barcelona | Barcelona | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Universitari Dexeus - Grupo Quirónsalud | Barcelona | |
Spain | Hospital Universitario de Basurto | Bilbao | Vizcaya |
Spain | Hospital San Pedro de Alcántara | Cáceres | |
Spain | Hospital Universitario Puerta del Mar | Cádiz | |
Spain | Hospital Provincial de Castellón | Castelló de la Plana | Castellón |
Spain | Hospital Universitario Reina Sofía | Córdoba | |
Spain | Hospital Universitario de Galdakao | Galdakao | Bizkaia |
Spain | Hospital Universitario Clínico San Cecilio | Granada | |
Spain | Hospital General de Granollers | Granollers | Barcelona |
Spain | Hospital Universitario de Guadalajara | Guadalajara | |
Spain | Hospital General San Jorge | Huesca | |
Spain | Complejo Hospitalario de Jaén - Hospital Médico-Quirúrgico | Jaén | |
Spain | Hospital Universitario de Jerez | Jerez De La Frontera | Cádiz |
Spain | Institut Català d´ Oncologia-Hospital Duran y Reynals | L'Hospitalet De Llobregat | Barcelona |
Spain | Hospital Universitari Arnau de Vilanova | Lleida | |
Spain | Clínica Universidad de Navarra | Madrid | |
Spain | Hospital Clínico San Carlos | Madrid | |
Spain | Hospital Universitario 12 De Octubre | Madrid | |
Spain | Hospital Universitario de La Princesa | Madrid | |
Spain | Hospital Universitario HM Sanchinarro | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
Spain | MD Anderson Cancer Center Madrid | Madrid | |
Spain | Hospital Universitario Puerta de Hierro | Majadahonda | Madrid |
Spain | Hospital Universitario Central de Asturias | Oviedo | Asturias |
Spain | Hospital Universari Son Espases | Palma De Mallorca | Islas Baleares |
Spain | Complejo Hospitalario Universitario de Pontevedra (Hospital Montecelo) | Pontevedra | |
Spain | Consorci Sanitari de Terrassa | Rubí | Barcelona |
Spain | Consorci Corporació Sanitària Parc Taulí de Sabadell | Sabadell | Barcelona |
Spain | Hospital Clínico Universitario de Salamanca | Salamanca | |
Spain | Hospital Universitario Donostia | San Sebastián | Gipuzkoa |
Spain | Hospital Universitario Infanta Sofia | San Sebastián De Los Reyes | Madrid |
Spain | Hospital Universitario Nuestra Señora de Candelaria | Santa Cruz De Tenerife | |
Spain | Hospital Universitario Marqués de Valdecilla | Santander | Cantabria |
Spain | Hospital Clínico Universitario de Santiago | Santiago De Compostela | A Coruña |
Spain | Hospital Quirónsalud Sagrado Corazón | Sevilla | |
Spain | Hospital Universitario de Valme | Sevilla | |
Spain | Hospital Universitario Virgen del Rocio | Sevilla | |
Spain | Consorcio Hospital General Universitario de Valencia | Valencia | |
Spain | Hospital Universitari i Politècnic La Fe | Valencia | |
Spain | Hospital Universitario Doctor Peset | Valencia | |
Spain | Hospital Clínico Universitario de Valladolid | Valladolid | |
Spain | Hospital Álvaro Cunqueiro | Vigo | Pontevedra |
Spain | Hospital Marina Baixa | Villajoyosa | Alicante |
Spain | Hospital Lluís Alcanyís de Xàtiva | Xàtiva | Valencia |
Spain | Hospital Clínico Universitario Lozano Blesa | Zaragoza | |
Spain | Hospital Universitario Miguel Servet | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Grupo Español de Investigación en Cáncer de Ovario |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Demographics | Month 4-6 | ||
Primary | Medical History | Month 4-6 | ||
Primary | Ovarian Cancer Diagnosis | Month 4-6 | ||
Primary | Ovarian Cancer Treatments (pre-Niraparib) | Month 4-6 | ||
Primary | Baseline (pre-Niraparib) | Month 4-6 | ||
Primary | Niraparib Treatment | Month 4-6 | ||
Primary | Niraparib Disease Progression | Month 4-6 | ||
Primary | Best Response Assessment | Month 4-6 | ||
Primary | Niraparib-Related Adverse Events | Month 4-6 | ||
Primary | Relevant Concomitant Medications | Month 4-6 | ||
Primary | Death | Month 4-6 | ||
Primary | Survival Status | Month 4-6 | ||
Primary | Subsequent Therapies for Ovarian Cancer | Month 4-6 |
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