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).
Study Type
OBSERVATIONAL
Enrollment
316
Patient's medical records will be screened by local clinical staff to assess for eligibility according to selection criteria. The study comprises a single study visit, in which the patient will give her informed consent to participate (when the patient is alive) and the physician will extract the study data from the patient's medical charts. 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).
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 Universari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Institut Català d'Oncología Badalona
Badalona, Barcelona, Spain
Demographics
Time frame: Month 4-6
Medical History
Time frame: Month 4-6
Ovarian Cancer Diagnosis
Time frame: Month 4-6
Ovarian Cancer Treatments (pre-Niraparib)
Time frame: Month 4-6
Baseline (pre-Niraparib)
Time frame: Month 4-6
Niraparib Treatment
Time frame: Month 4-6
Niraparib Disease Progression
Time frame: Month 4-6
Best Response Assessment
Time frame: Month 4-6
Niraparib-Related Adverse Events
Time frame: Month 4-6
Relevant Concomitant Medications
Time frame: Month 4-6
Death
Time frame: Month 4-6
Survival Status
Time frame: Month 4-6
Subsequent Therapies for Ovarian Cancer
Time frame: Month 4-6
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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
...and 47 more locations