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Epithelial Ovarian CancerNCT04546373

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

An observational study of Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Grupo Español de Investigación en Cáncer de Ovario at 57 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Niraparib
How many people
316 participants
Where
57 sitesSpain
Study dates
30 Sep 2020to 31 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).
Show all 16Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

57 sites in 1 country.

57 sites in 1 country

Spain57 sites

  • Complejo Hospitalario Universitario A Coruña (Juan Canalejo)

    A Coruña, 15006

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital Virgen de los Lirios

    Alcoy, Alicante, 03804

  • Hospital Universitari Sant Joan d'Alacant

    Alicante, 03550

  • Hospital Universitario Torrecárdenas

    Almería, 04009

  • Institut Català d'Oncología Badalona

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Clínica Corachan

    Barcelona, 08017

  • Hospital Universitari Dexeus - Grupo Quirónsalud

    Barcelona, 08028

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario de Basurto

    Bilbao, Vizcaya, 48013

  • Hospital San Pedro de Alcántara

    Cáceres, 10003

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

  • Hospital Provincial de Castellón

    Castellon, Castellón, 12002

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Universitario de Galdakao

    Galdakao, Bizkaia, 48960

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016

  • Hospital General de Granollers

    Granollers, Barcelona, 08402

  • Hospital Universitario de Guadalajara

    Guadalajara, 19002

  • Hospital General San Jorge

    Huesca, 22004

  • Complejo Hospitalario de Jaén - Hospital Médico-Quirúrgico

    Jaén, 23007

  • Hospital Universitario de Jerez

    Jerez de la Frontera, Cádiz, 11407

  • Institut Català d´ Oncologia-Hospital Duran y Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Clínica Universidad de Navarra

    Madrid, 28027

  • MD Anderson Cancer Center Madrid

    Madrid, 28033

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 De Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universari Son Espases

    Palma de Mallorca, Balearic Islands, 07120

  • Complejo Hospitalario Universitario de Pontevedra (Hospital Montecelo)

    Pontevedra, 36071

  • Consorci Sanitari de Terrassa

    Rubí, Barcelona, 08191

  • Consorci Corporació Sanitària Parc Taulí de Sabadell

    Sabadell, Barcelona, 08208

  • Hospital Clínico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Donostia

    San Sebastián, Gipuzkoa, 20014

  • Hospital Universitario Infanta Sofia

    San Sebastián de los Reyes, Madrid, 28702

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, 38010

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Clínico Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706

  • Hospital Quirónsalud Sagrado Corazón

    Seville, 41013

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario de Valme

    Seville, 41014

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitario Doctor Peset

    Valencia, 46017

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

  • Hospital Álvaro Cunqueiro

    Vigo, Pontevedra, 36213

  • Hospital Marina Baixa

    Villajoyosa, Alicante, 03570

  • Hospital Lluís Alcanyís de Xàtiva

    Xàtiva, Valencia, 46800

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

About this study

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

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).

Being tested
Niraparib
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demographics

    Measured: Month 4-6

  2. Medical History

    Measured: Month 4-6

  3. Ovarian Cancer Diagnosis

    Measured: Month 4-6

  4. Ovarian Cancer Treatments (pre-Niraparib)

    Measured: Month 4-6

  5. Baseline (pre-Niraparib)

    Measured: Month 4-6

  6. Niraparib Treatment

    Measured: Month 4-6

  7. Niraparib Disease Progression

    Measured: Month 4-6

  8. Best Response Assessment

    Measured: Month 4-6

  9. Niraparib-Related Adverse Events

    Measured: Month 4-6

  10. Relevant Concomitant Medications

    Measured: Month 4-6

  11. Death

    Measured: Month 4-6

  12. Survival Status

    Measured: Month 4-6

  13. Subsequent Therapies for Ovarian Cancer

    Measured: Month 4-6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2020
  2. Study start30 Sep 2020
  3. Primary completion31 Jul 2021
  4. Study completion31 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
316 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04546373
Sponsor's protocol ID
GEICO 88-R
Status last verified
Aug 2021
First submitted
2 Sep 2020
Last updated
5 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cueva JF, Palacio I, Churruca C, Herrero A, Pardo B, Constenla M, Santaballa A, Manso L, Estevez-Garcia P, Legeren M, Marquina G, de Juan A, Quintana JF, Gonzalez-Santiago S, Cassinello J, Reche P, Soriano ML, Valero M, Gaba L, Mar Gordon MD, Gomez-Raposo C, Hernando S, Marquez R, Fuentes J, Alarcon J, Taus A, Caballero C, Corbellas M, Iriarte E, Gonzalez-Martin A. Clinical outcomes and subsequent therapy in patients with platinum-sensitive recurrent ovarian cancer deriving long-term benefit from maintenance niraparib: a subgroup analysis of the GEICO-88R study. Int J Gynecol Cancer. 2025 Nov;35(11):102116. doi: 10.1016/j.ijgc.2025.102116. Epub 2025 Aug 16.

    PubMed 40974837

  • 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.

    PubMed 36706655

Questions about this trial

What is this clinical trial studying?

An observational study of Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Grupo Español de Investigación en Cáncer de Ovario at 57 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographics (time frame: Month 4-6). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04546373, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021; AzTrials last refreshed its copy on 1 Nov 2026.

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