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

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.

Study Overview

• Status: Completed
• Conditions: Fallopian Tube Cancer; Epithelial Ovarian Cancer; Primary Peritoneal Cancer
• Intervention / Treatment: Drug: Rucaparib

Detailed Description

An observational study (GEICO 87-R) was performed in high-grade ovarian cancer patients treated within the rucaparib access program (RAP) in Spain. The aim was to better understand rucaparib's management in real-life setting, to optimize future use, considering Pt-sensitive and Pt-resistant BRCAmut treatment and maintenance patients.

A retrospective study was performed at 22 GEICO hospitals in Spain that treated patients within RAP (600 mg BID) since September 2018. Adult women with high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer, with medical record available, were included. Patient characteristics, medical history, safety, efficacy, and dosing data were collected.

The setting of this observational study was rucaparib's access program (RAP) in Spain, in the context of real-life use of the product.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Spain
  • Andalusia
    • Almería, Andalusia, Spain, 04009
      • Hospital Torrecardenas
    • Málaga, Andalusia, Spain, 29010
      • Hospital Universitario Virgen de la Victoria
    • Seville, Andalusia, Spain, 41013
      • Hospital Universitario Virgen del Rocio
    • Seville, Andalusia, Spain, 41014
      • Hospital Universitario Nuestra Señora de Valme
  • Aragon
    • Huesca, Aragon, Spain, 22004
      • Hospital General San Jorge
    • Zaragoza, Aragon, Spain, 50009
      • Hospital Universitario Miguel Servet
    • Zaragoza, Aragon, Spain, 50009
      • Hospital Clinico Universitario Lozano Blesa
  • Balearic Islands
    • Palma de Mallorca, Balearic Islands, Spain, 07120
      • Hospital Universitario Son Espases
  • Catalonia
    • Barcelona, Catalonia, Spain, 08003
      • Hospital del Mar
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clinic i Provincial
  • Galicia
    • Pontevedra, Galicia, Spain, 36071
      • Complejo Hospitalario Universitario de Pontevedra
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Hospital Universitario de Fuenlabrada
    • Madrid, Madrid, Spain, 28040
      • Hospital Clinico San Carlos
    • Madrid, Madrid, Spain, 28050
      • Centro Integral Oncologico Clara Campal
    • Madrid, Madrid, Spain, 28041
      • Hospital Universitario 12 Octubre
    • Madrid, Madrid, Spain, 28027
      • Clinica Universidad de Navarra
    • Madrid, Madrid, Spain, 28033
      • Md Anderson Cancer Center
    • Madrid, Madrid, Spain, 28040
      • Hospital Universitario Fundacion Jimenez Diaz
    • San Sebastián de los Reyes, Madrid, Spain, 28702
      • Hospital Universitario Infanta Sofía
  • País Basco
    • Vitoria-Gasteiz, País Basco, Spain, 01009
      • Hospital Universitario de Araba Txagorritxu
  • Valencia
    • Valencia, Valencia, Spain, 46026
      • Hospital Universitari i Politecnic La Fe
    • Valencia, Valencia, Spain, 46009
      • Instituto Valenciano de Oncologia
    • Xàtiva, Valencia, Spain, 46800
      • Hospital Público Lluis Alcanyis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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).

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Relevant Co-morbidities	Patient characteristics and medical history Detected diseases include: arterial hypertension, diabetes melliutus, COPD, ischemic cardiomyopathy, cerebrovascular disease, obesity, etc. Measurements were done at baseline	0 months - Measurements were done at baseline
Other Previous Cancers?	Patient characteristics and medical history. Descriptive statistics: Other cancers present during trial including endometrial, breast , colorrectal, lung or other cancers Measurements were done at baseline	0 months - Measurements were done at baseline
Family History of Cancers?	Patient characteristics and medical history Family history of other cancers including ovarian, breast and others Measurements were done at baseline	0 months - Measurements were done at baseline
FIGO STAGE	Stage = tumor size and location; higher stage = more spread metastasis I Tumor confined to the corpus uteri IA No or less than half myometrial invasion IB Invasion equal to or more than half of the myometrium IC IA+IB + ascites IC1 surgical spill IC2 Capsule rupture before surgery or tumor on ovarian surface II Tumor invades cervical stroma, but does not extend beyond the uterus III Local and/or regional spread of the tumor IIIA Tumor invades the serosa of the corpus uteri and/or adnexae IIIA2 involvement of uterine subserosa or spread through uterine serosa IIIB Vaginal involvement and/or parametrial involvement IIIC Metastases to pelvic and/or para-aortic lymph nodes IIIC1 Positive pelvic nodes IIIC2 Positive para-aortic nodes with or without positive pelvic lymph nodes IV Tumor invades bladder and/or bowel mucosa, and/or distant metastases IVA Tumor invasion of bladder and/or bowel mucosa IVB Distant metastasis (intra-abdominal metastases and/or inguinal nodes)	0 months - Measurements were done at baseline
Tumor Histology	Patient characteristics and medical history Tumor histology history Measurements were done at baseline	0 months - Measurements were done at baseline
BCRA Status	Patient characteristics and medical history mutational status (BRCA 1/2 [germline/somatic] and in other HRR genes) Measurements were done at baseline	0 months - Measurements were done at baseline
Deficiencies in Other Genes Involved in Homologous Recombination	Patient characteristics and medical history Other HRR deficiencies including RAD51C, RAD51D, PALBB2, BRIP1, CHEK1, CHEK2, BARD1, FAM175A, NEN, ATM, EMSY and others Measurements were done at baseline	0 months - Measurements were done at baseline
Surgeries Before Rucaparib	Patient characteristics and medical history Total number of surgeries per patient before treatment started Measurements were done at baseline	0 months - Measurements were done at baseline
Previous Lines	Patient characteristics and medical history: Prior lines of platinum-based chemotherapy	0-24 months
PARPi Before Rucaparib	Patient characteristics and medical history: PARPi treatment before rucaparib Measurements were done at baseline	0 months - Measurements were done at baseline
Average Dose of Rucaparib Received Per 12 Hours	Rucaparib dosing data Descrption: average dose of rucaparib administered (mg/12h)	0-12 months
Rucaparib Drug Exposure	Rucaparib dosing data: mean starting dose, number of dose reductions, reasons for reductions, number of treatment discontinuations, reasons for discontinuations, duration of treatment, and switching of maintenance therapy to another PARP inhibitor (including reasons for switching). Rucaparib drug exposure in months Patient 14-001 has been eliminated for not following the treatment scheme	0-24 months
Dose Reductions	Rucaparib dosing data: mean starting dose, number of dose reductions, reasons for reductions, number of treatment discontinuations, reasons for discontinuations, duration of treatment, and switching of maintenance therapy to another PARP inhibitor (including reasons for switching). Specific description: How many dose reductions had to be conducted on each patient *Patient 14-001 from treatment group has been eliminated by not following the tratment scheme	0-12 months
Number of Dose Interruptions	Rucaparib dosing data: mean starting dose, number of dose reductions, reasons for reductions, number of treatment discontinuations, reasons for discontinuations, duration of treatment, and switching of maintenance therapy to another PARP inhibitor (including reasons for switching). Specific description: How many dose interruptions had to be conducted on each patient *Patient 14-001 from treatment group has been eliminated by not following the tratment scheme	0-12 months
Duration of Response (DoR)	Rucaparib efficacy data: best response rates in the treatment indication patients, duration of response and PFS in the treatment indication patients, PFS in the maintenance indication patients, radiological response to chemotherapy in maintenance patients (and impact of response on patient evolution). For maintenance patients: Duration of response has been calculated taking into account the date of CR or RP prior to RAP until progression (on last follow date) during Rucaparib as a maintenance treatment. For treatment patients: Duration of response has been calculated taking into account the best response date (PR or CR) during Rucaparib until progression of follow-up date (Only patients with PR or CR as best overall response)	0-36 months
End of Treatment	Rucaparib dosing data: mean starting dose, number of dose reductions, reasons for reductions, number of treatment discontinuations, reasons for discontinuations, duration of treatment, and switching of maintenance therapy to another PARP inhibitor (including reasons for switching). Description: Rucaparib exposure termination (reasons)	0-24 months
Objective Response Rate (ORR)	Rucaparib efficacy data ORR: Confirmed best overall tumor response of CR or PR according to RECIST v1.1 or Response and normalization or Response according to Rustin criteria. The RECIST v1.1 answer prevailed over the Rustin criterion answer except where RECIST is 'Not assessable' and Rustin criterion is different than 'Not assessable'. ORR was calculated only on the treatment population and not on the maintenance population. *This measurement was only taken in participants from the treatment group as these present an active disease, therefore Rucaparib was administered in order to reduce tumoral charge or control tumor progression. On the other hand, participants from the maintenance group have already responded to previous treatments, and rucaparib was administered I order to maintain response rate and/or delay progression, which was measured using "free-progression survival".	0-24 months
Progression-free Survival (PFS)	Rucaparib efficacy data: best response rates in the treatment indication patients, duration of response and PFS in the treatment indication patients, PFS in the maintenance indication patients, radiological response to chemotherapy in maintenance patients (and impact of response on patient evolution). It represents the length of time during and after treatment that a patient lives with the disease, but without it getting worse.	0-24 months
Radiological Best Overall Response	Rucaparib efficacy data Radiological best overall response - Only 19 radiologically evaluable patients (treatment group only) *This measurement was only taken in participants from the treatment group as these present an active disease, therefore Rucaparib was administered in order to reduce tumoral charge or control tumor progression. On the other hand, participants from the maintenance group have already responded to previous treatments, and rucaparib was administered I order to maintain response rate and/or delay progression, which was measured using "free-progression survival".	0-24 months
Biological Best Overall Response	Rucaparib efficacy data: best response rates in the treatment indication patients, duration of response and PFS in the treatment indication patients, PFS in the maintenance indication patients, radiological response to chemotherapy in maintenance patients (and impact of response on patient evolution). Biological best overall response - Only 16 assessable patients (Treatment arm only) *This measurement was only taken in participants from the treatment group as these present an active disease, therefore Rucaparib was administered in order to reduce tumoral charge or control tumor progression. On the other hand, participants from the maintenance group have already responded to previous treatments, and rucaparib was administered I order to maintain response rate and/or delay progression, which was measured using "free-progression survival".	0-24 months

Collaborators and Investigators

• Sponsor: Grupo Español de Investigación en Cáncer de Ovario
• Collaborators: Clovis Oncology, Inc.
• Investigators: Principal Investigator: Alfonso Yubero, Dr., Hospital Clinico Universitario Lozano Blesa

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2020
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Rucaparib
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Fallopian Tube Diseases; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; rucaparib
• Other Study ID Numbers: GEICO 87-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