Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer

NCT ID: NCT04546373

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 316 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2021-07-31

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).

Conditions

Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

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).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Grupo Español de Investigación en Cáncer de Ovario

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan F. Cueva Bañuelos, Dr.

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario Universitario de Santiago de Compostela

Locations

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

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

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Provincial de Castellón

Castellon, Castellón, Spain

Hospital Universitario de Jerez

Jerez de la Frontera, Cádiz, Spain

Hospital Universitario Donostia

San Sebastián, Gipuzkoa, Spain

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital Universitario Infanta Sofia

San Sebastián de los Reyes, Madrid, Spain

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Lluís Alcanyís de Xàtiva

Xàtiva, Valencia, Spain

Hospital Universitario de Basurto

Bilbao, Vizcaya, Spain

Complejo Hospitalario Universitario A Coruña (Juan Canalejo)

A Coruña, , Spain

Hospital Universitari Sant Joan d'Alacant

Alicante, , Spain

Hospital Universitario Torrecárdenas

Almería, , Spain

Hospital del Mar

Barcelona, , Spain

Clínica Corachan

Barcelona, , Spain

Hospital Universitari Dexeus - Grupo Quirónsalud

Barcelona, , Spain

Hospital Clínic i Provincial de Barcelona

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Puerta del Mar

Cadiz, , Spain

Hospital San Pedro de Alcántara

Cáceres, , Spain

Hospital Universitario Reina Sofía

Córdoba, , Spain

Hospital Universitario Clínico San Cecilio

Granada, , Spain

Hospital Universitario de Guadalajara

Guadalajara, , Spain

Hospital General San Jorge

Huesca, , Spain

Complejo Hospitalario de Jaén - Hospital Médico-Quirúrgico

Jaén, , Spain

Hospital Universitari Arnau de Vilanova

Lleida, , Spain

Hospital Universitario de La Princesa

Madrid, , Spain

Clínica Universidad de Navarra

Madrid, , Spain

MD Anderson Cancer Center Madrid

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital Universitario 12 De Octubre

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario HM Sanchinarro

Madrid, , Spain

Complejo Hospitalario Universitario de Pontevedra (Hospital Montecelo)

Pontevedra, , Spain

Hospital Clínico Universitario de Salamanca

Salamanca, , Spain

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, , Spain

Hospital Quirónsalud Sagrado Corazón

Seville, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Universitario de Valme

Seville, , Spain

Consorcio Hospital General Universitario de Valencia

Valencia, , Spain

Hospital Universitario Doctor Peset

Valencia, , Spain

Hospital Universitari i Politècnic La Fe

Valencia, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Countries

Spain

References

Cueva JF, Palacio I, Churruca C, Herrero A, Pardo B, Constenla M, Santaballa A, Manso L, Estevez P, Maximiano C, Legeren M, Marquina G, de Juan A, Quindos M, Sanchez L, Barquin A, Fernandez I, Martin C, Juarez A, Martin T, Garcia Y, Yubero A, Gallego A, Martinez Bueno A, Guerra E, Gonzalez-Martin A. Real-world safety and effectiveness of maintenance niraparib for platinum-sensitive recurrent ovarian cancer: A GEICO retrospective observational study within the Spanish expanded-access programme. Eur J Cancer. 2023 Mar;182:3-14. doi: 10.1016/j.ejca.2022.12.023. Epub 2022 Dec 29.

Reference Type: DERIVED

PMID: 36706655 (View on PubMed)

Other Identifiers

GEICO 88-R

Identifier Type: -

Identifier Source: org_study_id