Clinical trial NCT04546373: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Lead sponsor: Grupo Español de Investigación en Cáncer de Ovario
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 316
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female patients with diagnosis of high grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, with recurrent disease sensitive to platinum, treated within the Spanish niraparib EAP.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Demographics
timeFrame: Month 4-6
measure: Medical History
timeFrame: Month 4-6
measure: Ovarian Cancer Diagnosis
timeFrame: Month 4-6
measure: Ovarian Cancer Treatments (pre-Niraparib)
timeFrame: Month 4-6
measure: Baseline (pre-Niraparib)
timeFrame: Month 4-6
measure: Niraparib Treatment
timeFrame: Month 4-6
measure: Niraparib Disease Progression
timeFrame: Month 4-6
measure: Best Response Assessment
timeFrame: Month 4-6
measure: Niraparib-Related Adverse Events
timeFrame: Month 4-6
measure: Relevant Concomitant Medications
timeFrame: Month 4-6
measure: Death
timeFrame: Month 4-6
measure: Survival Status
timeFrame: Month 4-6
measure: Subsequent Therapies for Ovarian Cancer
timeFrame: Month 4-6
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
state: A Coruña
city: Alcoy
country: Spain
facility: Hospital Virgen de los Lirios
state: Alicante
city: Villajoyosa
country: Spain
facility: Hospital Marina Baixa
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Institut Català d'Oncología Badalona
state: Barcelona
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Català d´ Oncologia-Hospital Duran y Reynals
state: Barcelona
city: Rubí
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Sabadell
country: Spain
facility: Consorci Corporació Sanitària Parc Taulí de Sabadell
state: Barcelona
city: Galdakao
country: Spain
facility: Hospital Universitario de Galdakao
state: Bizkaia
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Castelló de la Plana
country: Spain
facility: Hospital Provincial de Castellón
state: Castellón
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario de Jerez
state: Cádiz
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
state: Gipuzkoa
city: Palma De Mallorca
country: Spain
facility: Hospital Universari Son Espases
state: Islas Baleares
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: San Sebastián De Los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofia
state: Madrid
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Pontevedra
city: Xàtiva
country: Spain
facility: Hospital Lluís Alcanyís de Xàtiva
state: Valencia
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
state: Vizcaya
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (Juan Canalejo)
city: Alicante
country: Spain
facility: Hospital Universitari Sant Joan d'Alacant
city: Almería
country: Spain
facility: Hospital Universitario Torrecárdenas
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Clínica Corachan
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus - Grupo Quirónsalud
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Clínico San Cecilio
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Huesca
country: Spain
facility: Hospital General San Jorge
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén - Hospital Médico-Quirúrgico
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra
city: Madrid
country: Spain
facility: MD Anderson Cancer Center Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 De Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario de Pontevedra (Hospital Montecelo)
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Sevilla
country: Spain
facility: Hospital Quirónsalud Sagrado Corazón
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Complejo Hospitalario Universitario de Santiago de Compostela
name: Juan F. Cueva Bañuelos, Dr.
role: PRINCIPAL_INVESTIGATOR
References: