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

August 4, 2021 updated by: Grupo Español de Investigación en Cáncer de Ovario

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

316

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña (Juan Canalejo)
      • Alicante, Spain, 03550
        • Hospital Universitari Sant Joan D'Alacant
      • Almería, Spain, 04009
        • Hospital Universitario Torrecárdenas
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08036
        • Hospital Clínic i Provincial de Barcelona
      • Barcelona, Spain, 08017
        • Clinica Corachan
      • Barcelona, Spain, 08028
        • Hospital Universitari Dexeus - Grupo Quirónsalud
      • Cáceres, Spain, 10003
        • Hospital San Pedro de Alcantara
      • Cádiz, Spain, 11009
        • Hospital Universitario Puerta Del Mar
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Granada, Spain, 18016
        • Hospital Universitario Clínico San Cecilio
      • Guadalajara, Spain, 19002
        • Hospital Universitario de Guadalajara
      • Huesca, Spain, 22004
        • Hospital General San Jorge
      • Jaén, Spain, 23007
        • Complejo Hospitalario de Jaén - Hospital Médico-Quirúrgico
      • Lleida, Spain, 25198
        • Hospital Universitari Arnau de Vilanova
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital Universitario 12 De Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28006
        • Hospital Universitario de la Princesa
      • Madrid, Spain, 28027
        • Clinica Universidad de Navarra
      • Madrid, Spain, 28033
        • MD Anderson Cancer Center Madrid
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro
      • Pontevedra, Spain, 36071
        • Complejo Hospitalario Universitario de Pontevedra (Hospital Montecelo)
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca
      • Santa Cruz De Tenerife, Spain, 38010
        • Hospital Universitario Nuestra Señora de Candelaria
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Sevilla, Spain, 41014
        • Hospital Universitario de Valme
      • Sevilla, Spain, 41013
        • Hospital Quirónsalud Sagrado Corazón
      • Valencia, Spain, 46026
        • Hospital Universitari I Politecnic La Fe
      • Valencia, Spain, 46017
        • Hospital Universitario Doctor Peset
      • Valencia, Spain, 46014
        • Consorcio Hospital General Universitario de Valencia
      • Valladolid, Spain, 47003
        • Hospital Clínico Universitario de Valladolid
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15706
        • Hospital Clinico Universitario de Santiago
    • Alicante
      • Alcoy, Alicante, Spain, 03804
        • Hospital Virgen de los Lirios
      • Villajoyosa, Alicante, Spain, 03570
        • Hospital Marina Baixa
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Institut Català d'Oncologia Badalona
      • Granollers, Barcelona, Spain, 08402
        • Hospital General de Granollers
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
        • Institut Català d´ Oncologia-Hospital Duran y Reynals
      • Rubí, Barcelona, Spain, 08191
        • Consorci Sanitari de Terrassa
      • Sabadell, Barcelona, Spain, 08208
        • Consorci Corporació Sanitària Parc Taulí de Sabadell
    • Bizkaia
      • Galdakao, Bizkaia, Spain, 48960
        • Hospital Universitario de Galdakao
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Castellón
      • Castelló de la Plana, Castellón, Spain, 12002
        • Hospital Provincial de Castellón
    • Cádiz
      • Jerez De La Frontera, Cádiz, Spain, 11407
        • Hospital Universitario De Jerez
    • Gipuzkoa
      • San Sebastián, Gipuzkoa, Spain, 20014
        • Hospital Universitario Donostia
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Spain, 07120
        • Hospital Universari Son Espases
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
      • San Sebastián De Los Reyes, Madrid, Spain, 28702
        • Hospital Universitario Infanta Sofía
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36213
        • Hospital Álvaro Cunqueiro
    • Valencia
      • Xàtiva, Valencia, Spain, 46800
        • Hospital Lluís Alcanyís de Xàtiva
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital Universitario de Basurto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Demographics
Time Frame: Month 4-6
Month 4-6
Medical History
Time Frame: Month 4-6
Month 4-6
Ovarian Cancer Diagnosis
Time Frame: Month 4-6
Month 4-6
Ovarian Cancer Treatments (pre-Niraparib)
Time Frame: Month 4-6
Month 4-6
Baseline (pre-Niraparib)
Time Frame: Month 4-6
Month 4-6
Niraparib Treatment
Time Frame: Month 4-6
Month 4-6
Niraparib Disease Progression
Time Frame: Month 4-6
Month 4-6
Best Response Assessment
Time Frame: Month 4-6
Month 4-6
Niraparib-Related Adverse Events
Time Frame: Month 4-6
Month 4-6
Relevant Concomitant Medications
Time Frame: Month 4-6
Month 4-6
Death
Time Frame: Month 4-6
Month 4-6
Survival Status
Time Frame: Month 4-6
Month 4-6
Subsequent Therapies for Ovarian Cancer
Time Frame: Month 4-6
Month 4-6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Español de Investigación en Cáncer de Ovario

Investigators

  • Principal Investigator: Juan F. Cueva Bañuelos, Dr., Complejo Hospitalario Universitario De Santiago De Compostela

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2020

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 7, 2020

First Posted (Actual)

September 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEICO 88-R

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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