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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
Sponsor:
Collaborator:
Clovis Oncology, Inc.
Information provided by (Responsible Party):
Grupo Español de Investigación en Cáncer de Ovario

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

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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



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.


Primary Outcome Measures :
  1. 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).

  2. 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.

  3. Rucaparib efficacy data [ Time Frame: Month 10-12 ]
  4. Rucaparib dosing data [ Time Frame: Month 10-12 ]
  5. 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.



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:

  1. 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.
  2. Histological diagnosis of high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
  3. 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).


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 Show 23 study locations
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
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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