Epithelial Ovarian CancerNCT04539327
Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study
An observational study of Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Grupo Español de Investigación en Cáncer de Ovario at 23 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- Rucaparib
- How many people
- 51 participants
- Where
- 23 sitesSpain
- Study dates
- 29 Jul 2020to 31 Jul 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 (18 years or more) women diagnosed with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer
Who may be able to join
- 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).
Who cannot join
- 1. Patients without medical record available (lost, empty or unretrievable clinical information).
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Spain23 sites
Hospital Torrecárdenas
Almería, Andalusia, 04009
Hospital del Mar
Barcelona, Catalonia, 08003
Hospital Clínic i Provincial
Barcelona, Catalonia, 08036
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital General San Jorge
Huesca, Aragon, 22004
Clínica Universidad de Navarra
Madrid, Madrid, 28027
MD Anderson Cancer Center
Madrid, Madrid, 28033
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital Universitario 12 Octubre
Madrid, Madrid, 28041
Centro Integral Oncológico Clara Campal
Madrid, Madrid, 28050
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, 29010
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
Complejo Hospitalario Universitario de Pontevedra
Pontevedra, Galicia, 36071
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702
Hospital Universitario Virgen del Rocío
Seville, Andalusia, 41013
Hospital Universitario Nuestra Señora de Valme
Seville, Andalusia, 41014
Instituto Valenciano De Oncologia
Valencia, Valencia, 46009
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026
Hospital Universitario de Araba Txagorritxu
Vitoria-Gasteiz, Basque Country, 01009
Hospital Público Lluis Alcanyis
Xàtiva, Valencia, 46800
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, 50009
Hospital Universitario Miguel Servet
Zaragoza, Aragon, 50009
About this 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.
Read more
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.
Read the 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.
- Being tested
- Rucaparib
- Keywords
- Rucaparib
- 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.
RucaparibDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 0 months - Measurements were done at baseline
Tumor Histology
Patient characteristics and medical history Tumor histology history Measurements were done at baseline
Measured: 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
Measured: 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
Measured: 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
Measured: 0 months - Measurements were done at baseline
Previous Lines
Patient characteristics and medical history:
Prior lines of platinum-based chemotherapy
Measured: 0-24 months
PARPi Before Rucaparib
Patient characteristics and medical history:
PARPi treatment before rucaparib Measurements were done at baseline
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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".
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 0-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start29 Jul 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Investigación en Cáncer de Ovario
- Sponsor type
- University, hospital or other
- Collaborators
- Clovis Oncology, Inc.
- Responsible party
- Sponsor
- Investigators
- Alfonso Yubero, Dr., Principal investigator, Hospital Clínico Universitario Lozano Blesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539327
- Sponsor's protocol ID
- GEICO 87-R
- Status last verified
- Feb 2026
- First submitted
- 10 Aug 2020
- Last updated
- 18 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study
- ClinicalTrials.gov ID
- NCT04539327
- Acronym / sponsor ID
- GEICO 87-R
- Keywords
- Rucaparib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Grupo Español de Investigación en Cáncer de OvarioUniversity, hospital or other
- Collaborators
- Clovis Oncology, Inc.
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Posted 18 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (18 years or more) women diagnosed with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 1. Patients without medical record available (lost, empty or unretrievable clinical information).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RucaparibParticipating 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. | Drug | – |
Primary outcome
Number of Participants With Relevant Co-morbidities
Time frame: 0 months - Measurements were done at baseline
Patient characteristics and medical history Detected diseases include: arterial hypertension, diabetes melliutus, COPD, ischemic cardiomyopathy, cerebrovascular disease, obesity, etc. Measurements were done at baseline
Other Previous Cancers?
Time frame: 0 months - Measurements were done at baseline
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
Family History of Cancers?
Time frame: 0 months - Measurements were done at baseline
Patient characteristics and medical history Family history of other cancers including ovarian, breast and others Measurements were done at baseline
FIGO STAGE
Time frame: 0 months - Measurements were done at baseline
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)
Tumor Histology
Time frame: 0 months - Measurements were done at baseline
Patient characteristics and medical history Tumor histology history Measurements were done at baseline
BCRA Status
Time frame: 0 months - Measurements were done at baseline
Patient characteristics and medical history mutational status (BRCA 1/2 [germline/somatic] and in other HRR genes) Measurements were done at baseline
Deficiencies in Other Genes Involved in Homologous Recombination
Time frame: 0 months - Measurements were done at baseline
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
Surgeries Before Rucaparib
Time frame: 0 months - Measurements were done at baseline
Patient characteristics and medical history Total number of surgeries per patient before treatment started Measurements were done at baseline
Previous Lines
Time frame: 0-24 months
Patient characteristics and medical history: Prior lines of platinum-based chemotherapy
PARPi Before Rucaparib
Time frame: 0 months - Measurements were done at baseline
Patient characteristics and medical history: PARPi treatment before rucaparib Measurements were done at baseline
Average Dose of Rucaparib Received Per 12 Hours
Time frame: 0-12 months
Rucaparib dosing data Descrption: average dose of rucaparib administered (mg/12h)
Rucaparib Drug Exposure
Time frame: 0-24 months
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
Dose Reductions
Time frame: 0-12 months
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
Number of Dose Interruptions
Time frame: 0-12 months
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
Duration of Response (DoR)
Time frame: 0-36 months
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)
End of Treatment
Time frame: 0-24 months
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)
Objective Response Rate (ORR)
Time frame: 0-24 months
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".
Progression-free Survival (PFS)
Time frame: 0-24 months
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.
Radiological Best Overall Response
Time frame: 0-24 months
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".
Biological Best Overall Response
Time frame: 0-24 months
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".
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfonso Yubero, Dr. principal investigator
Hospital Clínico Universitario Lozano Blesa
23 sites in 1 country: see every site and its status.
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 23 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 3 inclusion and 1 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Relevant Co-morbidities (time frame: 0 months - Measurements were done at baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.