N/A
Completed N=51
Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study
epithelial ovarian cancer · Fallopian tube cancer · Primary Peritoneal Cancer
Source: ClinicalTrials.gov NCT04539327 ↗
Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Number of Participants With Relevant Co-morbidities — 15; 12 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Relevant Co-morbidities |
15; 12 | — |
| PRIMARY Other Previous Cancers? |
8; 3 | — |
| PRIMARY Family History of Cancers? |
22; 8 | — |
| PRIMARY FIGO STAGE |
0; 1; 0; 1; 1; 0 | — |
| PRIMARY Tumor Histology |
28; 17; 1; 1; 2; 0 | — |
| PRIMARY BCRA Status |
28; 3; 3; 13; 2; 2 | — |
| PRIMARY Deficiencies in Other Genes Involved in Homologous Recombination |
19; 8 | — |
| PRIMARY Surgeries Before Rucaparib |
1; 0; 25; 13; 4; 5 | — |
| PRIMARY Previous Lines |
4.7; 3.1 | — |
| PRIMARY PARPi Before Rucaparib |
13; 1 | — |
| PRIMARY Average Dose of Rucaparib Received Per 12 Hours |
545.5; 513.5 | — |
| PRIMARY Rucaparib Drug Exposure |
30; 12; 1; 3; 2; 0 | — |
| PRIMARY Dose Reductions |
18; 7; 11; 5; 3; 5 | — |
| PRIMARY Number of Dose Interruptions |
12; 8; 13; 8; 7; 0 | — |
| PRIMARY Duration of Response (DoR) |
5.7; 13.2 | — |
| PRIMARY End of Treatment |
23; 13; 1; 1; 4; 1 | — |
| PRIMARY Objective Response Rate (ORR) |
11; 4; 4; 0; 9 | — |
| PRIMARY Progression-free Survival (PFS) |
2.8; 9.1 | — |
| PRIMARY Radiological Best Overall Response |
11; 4; 4 | — |
| PRIMARY Biological Best Overall Response |
6; 7; 3 | — |
Eligibility 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
- Patients without medical record available (lost, empty or unretrievable clinical information).
Data sourced from ClinicalTrials.gov (NCT04539327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.