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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546373
• Other study ID #: GEICO 88-R
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Primary Peritoneal Cancer

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