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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

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

Clinical Trial 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).


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Niraparib
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).

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Grupo Español de Investigación en Cáncer de Ovario

Country where clinical trial is conducted

Spain, 

Outcome

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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