Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study

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ClinicalTrials.gov Identifier: NCT04539327

Recruitment Status : Recruiting

First Posted : September 7, 2020

Last Update Posted : September 7, 2020

See Contacts and Locations

Sponsor:

Collaborator:

Clovis Oncology, Inc.

Information provided by (Responsible Party):

Grupo Español de Investigación en Cáncer de Ovario

Study Description

Brief Summary:

The study consists of a retrospective observational, multicenter study in which the fundamental exposure factor being investigated is a drug (rucaparib).

A clinical database will be built including clinical data in three scenarios of rucaparib treatment: (1) platinum-sensitive BRCA-mutated patients after progression, (2) maintenance therapy in patients after a platinum-sensitive relapse in response, and (3) treatment therapy in BRCA-mutated patients who are currently platinum-resistant.

The specific objectives of the study are:

To describe patient characteristics/medical history, safety, efficacy, and dosing of on-label treatment with rucaparib in real-world patients (real-world data).
To describe patient characteristics/medical history, safety, efficacy, and dosing of all patients treated with rucaparib (including patients with on-label treatment and others) in real-world patients (real-world data).
To show that data obtained in clinical trials could be reproduced in non-screened patients.

Condition or disease	Intervention/treatment
Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer	Drug: Rucaparib

Study Design

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Study Type :	Observational
Estimated Enrollment :	70 participants
Observational Model:	Case-Only
Time Perspective:	Retrospective
Official Title:	Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study
Actual Study Start Date :	July 29, 2020
Estimated Primary Completion Date :	July 29, 2021
Estimated Study Completion Date :	July 29, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Ovarian cancer

Drug Information available for: Rucaparib

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Fallopian Tube Cancer Ovarian Epithelial Cancer

U.S. FDA Resources

Groups and Cohorts

Intervention Details:

Drug: Rucaparib
Participating local sites (GEICO-associated hospitals with expertise in gynecological cancer management) will enter clinical data of those patients who have previously participated in the rucaparib access program (RAP) in Spain and have given their consent.

Outcome Measures

Primary Outcome Measures :

Patient characteristics and medical history [ Time Frame: Month 10-12 ]
Sex, age, mutational status (BRCA 1/2 [germline/somatic] and in other homologous recombination repair (HRR) genes), number of previous relapses, number of previous chemotherapy regimens, types of treatments received (chemotherapy, targeted therapies [bevacizumab, PARP inhibitors (PARPi)]), prior maintenance or with maintenance, treatment-free interval (platinum-based chemotherapy, non-platinum-based chemotherapy, targeted therapy).
Rucaparib safety data: Adverse Events [ Time Frame: Month 10-12 ]
All rucaparib-related hematological and non-hematological, serious and non-serious adverse events (grade, start date, end date, action taken with rucaparib, outcome). In addition, adverse event treatments will be registered in the study database.
Rucaparib efficacy data [ Time Frame: Month 10-12 ]
Rucaparib dosing data [ Time Frame: Month 10-12 ]
Data reproducibility [ Time Frame: Month 10-12 ]
In order to show that data obtained in clinical trials could be reproduced in non-screened patients, the outcomes will be discussed in the context of the results from ARIEL3 trial and the integrated analysis of Study 10 and ARIEL2.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult (18 years or more) women diagnosed with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer

Criteria

Inclusion Criteria:

Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccessible patients (dead, lost, etc.) according to ethics committee permissions and applicable law for retrospective studies in Spain.
Histological diagnosis of high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
Adult women (18 years or more at the time of diagnosis).

Exclusion Criteria:

1. Patients without medical record available (lost, empty or unretrievable clinical information).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04539327

Contacts

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Contact: Patricio Ledesma	+34 971439900	ensayos@sofpromed.com

Locations

Show 23 study locations

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Spain
Hospital Torrecárdenas	Not yet recruiting
Almería, Andalucía, Spain, 04009
Contact: Piedad Reche Molina, Dra.
Principal Investigator: Piedad Reche Molina, Dra.
Hospital Universitario Virgen de la Victoria	Not yet recruiting
Málaga, Andalucía, Spain, 29010
Contact: Bella Pajares Hachero, Dra. +34 951 032083
Principal Investigator: Bella Pajares Hachero, Dra.
Hospital Universitario Virgen del Rocío	Not yet recruiting
Sevilla, Andalucía, Spain, 41013
Contact: Purificación Estévez García, Dra. +34 955 013068 puriestevez@gmail.com
Principal Investigator: Purificación Estévez García, Dra.
Sub-Investigator: Elisa Calvo García, Dra.
Hospital Universitario Nuestra Señora de Valme	Not yet recruiting
Sevilla, Andalucía, Spain, 41014
Contact: Carlos Enrique Robles Barraza, Dr. +34 955016189 croblesbarraza@yahoo.es
Principal Investigator: Carlos Enrique Robles Barraza, Dr.
Sub-Investigator: José Fuentes Pradera, Dr.
Hospital General San Jorge	Not yet recruiting
Huesca, Aragón, Spain, 22004
Contact: Julia Madani Pérez, Dra. +34 619375270 julimuna@hotmail.com
Principal Investigator: Julia Madani Pérez, Dra.
Hospital Clínico Universitario Lozano Blesa	Not yet recruiting
Zaragoza, Aragón, Spain, 50009
Contact: Alfonso Yubero Esteban, Dr. +34 976 765746 ayuberoe@salud.aragon.es
Principal Investigator: Alfonso Yubero Esteban, Dr.
Sub-Investigator: Irene Torres, Dra.
Hospital Universitario Miguel Servet	Not yet recruiting
Zaragoza, Aragón, Spain, 50009
Contact: Ana María Herrero Ibáñez, Dra. +34 976 765500 ext 3827 herreroa@yahoo.es
Principal Investigator: Ana María Herrero Ibáñez, Dra.
Sub-Investigator: Maria Eugenia Ortega Izquierdo, Dra.
Hospital del Mar	Not yet recruiting
Barcelona, Catalunya, Spain, 08003
Contact: Álvaro Taus García, Dr. +34 93 248 31 37 96720@parcdesalutmar.cat
Principal Investigator: Álvaro Taus García, Dr.
Hospital Clínic i Provincial	Not yet recruiting
Barcelona, Catalunya, Spain, 08036
Contact: Lydia Gaba Garcia, Dra. +34932275400 ext 4206 lgaba@clinic.ub.es
Principal Investigator: Lydia Gaba Garcia, Dra.
Instituto Valenciano De Oncologia	Not yet recruiting
Valencia, Comunitat Valenciana, Spain, 46009
Contact: Ignacio Romero Noguera, Dr. +34 96 110 46 25 iromero@fivo.org
Principal Investigator: Ignacio Romero Noguera, Dr.
Hospital Universitari i Politecnic La Fe	Not yet recruiting
Valencia, Comunitat Valenciana, Spain, 46026
Contact: Ana Santaballa Bertrán, Dra. +34 661 648 789 santaballa_ana@gva.es
Principal Investigator: Ana Santaballa Bertrán, Dra.
Sub-Investigator: Carmen Cañabate Arias, Dra.
Sub-Investigator: Helena Sélica de la Cueva Sapiña, Dra.
Hospital Público Lluis Alcanyis	Not yet recruiting
Xàtiva, Comunitat Valenciana, Spain, 46800
Contact: Carmen Salvador Coloma, Dra. +34 96 2289968 salvador_carcol@gva.es
Principal Investigator: Carmen Salvador Coloma, Dra.
Sub-Investigator: Isabel Navarro Cortina, Dra.
Sub-Investigator: Pedro López Tendero, Dr.
Complejo Hospitalario Universitario de Pontevedra	Not yet recruiting
Pontevedra, Galicia, Spain, 36071
Contact: Manuel Constenla Figueiras, Dr.
Principal Investigator: Manuel Constenla Figueiras, Dr.
Hospital Universitario Son Espases	Not yet recruiting
Palma De Mallorca, Islas Baleares, Spain, 07120
Contact: Jesús Damián Alarcón, Dr. jesus.alarcon@ssib.es
Principal Investigator: Jesús Damián Alarcón, Dr.
Sub-Investigator: Neus Ferrer Tur, Dra.
Hospital Universitario de Fuenlabrada	Not yet recruiting
Fuenlabrada, Madrid, Spain, 28942
Contact: Julia Calzas Rodríguez, Dra.
Principal Investigator: Julia Calzas Rodríguez, Dra.
Hospital Universitario Infanta Sofía	Not yet recruiting
San Sebastián de los Reyes, Madrid, Spain, 28702
Contact: María Merino Salvador, Dra. mmerinos.hulp@salud.madrid.org
Principal Investigator: María Merino Salvador, Dra.
Hospital Universitario de Araba Txagorritxu	Not yet recruiting
Gasteiz / Vitoria, País Basco, Spain, 01009
Contact: Maria Gutiérrez Toribio, Dra.
Principal Investigator: Maria Gutiérrez Toribio, Dra.
Clínica Universidad de Navarra	Not yet recruiting
Madrid, Spain, 28027
Contact: María Luísa Sánchez Lorenzo, Dra. +34 913 53 19 20 lsanchez@unav.es
Principal Investigator: María Luísa Sánchez Lorenzo, Dra.
MD Anderson Cancer Center	Not yet recruiting
Madrid, Spain, 28033
Contact: Raúl Márquez Vázquez, Dr. +34 917 878 600 ext 1334 mmarquezv@mdanderson.es
Principal Investigator: Raúl Márquez Vázquez, Dr.
Sub-Investigator: Isabel Gallegos Sancho, Dra.
Hospital Clínico San Carlos	Recruiting
Madrid, Spain, 28040
Contact: Gloria Marquina Ospina, Dra. +34 636098568 gloriamarquina@gmail.com
Principal Investigator: Gloria Marquina Ospina, Dra.
Hospital Universitario Fundación Jiménez Díaz	Not yet recruiting
Madrid, Spain, 28040
Contact: Victoria Casado Echarren, Dra.
Principal Investigator: Victoria Casado Echarren, Dra.
Hospital Universitario 12 Octubre	Not yet recruiting
Madrid, Spain, 28041
Contact: Luis Manuel Manso Sánchez, Dr. +34 91 390 80 03 ext 8003 luigimanso@gmail.com
Principal Investigator: Luis Manuel Manso Sánchez, Dr.
Sub-Investigator: Laura Lema Roso, Dra.
Sub-Investigator: Ana Sánchez de Torre, Dra.
Sub-Investigator: Eva María Ciruelos Gil, Dra.
Sub-Investigator: Pablo Tolosa Ortega, Dr.
Centro Integral Oncológico Clara Campal	Not yet recruiting
Madrid, Spain, 28050
Contact: Arántzazu Barquin Garcia, Dra. abarquin@hmhospitales.com
Principal Investigator: Arántzazu Barquin Garcia, Dra.

Sponsors and Collaborators

Grupo Español de Investigación en Cáncer de Ovario

Clovis Oncology, Inc.

Investigators

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Principal Investigator:	Alfonso Yubero, Dr.	Hospital Clínico Universitario Lozano Blesa

More Information

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Responsible Party:	Grupo Español de Investigación en Cáncer de Ovario
ClinicalTrials.gov Identifier:	NCT04539327
Other Study ID Numbers:	GEICO 87-R
First Posted:	September 7, 2020 Key Record Dates
Last Update Posted:	September 7, 2020
Last Verified:	September 2020

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Grupo Español de Investigación en Cáncer de Ovario:


Rucaparib

Additional relevant MeSH terms:

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Fallopian Tube Neoplasms Carcinoma, Ovarian Epithelial Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases	Gonadal Disorders Fallopian Tube Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Rucaparib Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

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