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

NCT04539327 | Completed Results

• 1 other identifier: GEICO 87-R
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 23

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.

Conditions

Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Keywords

Rucaparib

Outcome Measures

Primary Outcomes (20)

• 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

Interventions

Rucaparib DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Grupo Español de Investigación en Cáncer de Ovario: lead
• Clovis Oncology, Inc.: collaborator

Study Sites (23)

Hospital Torrecárdenas

Almería, Andalusia, 04009, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, 29010, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Andalusia, 41013, Spain

Location

Hospital Universitario Nuestra Señora de Valme

Seville, Andalusia, 41014, Spain

Location

Hospital General San Jorge

Huesca, Aragon, 22004, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, 50009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Aragon, 50009, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

Hospital Clínic i Provincial

Barcelona, Catalonia, 08036, Spain

Location

Complejo Hospitalario Universitario de Pontevedra

Pontevedra, Galicia, 36071, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Clínica Universidad de Navarra

Madrid, Madrid, 28027, Spain

Location

MD Anderson Cancer Center

Madrid, Madrid, 28033, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario 12 Octubre

Madrid, Madrid, 28041, Spain

Location

Centro Integral Oncológico Clara Campal

Madrid, Madrid, 28050, Spain

Location

Hospital Universitario Infanta Sofía

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Hospital Universitario de Araba Txagorritxu

Vitoria-Gasteiz, País Basco, 01009, Spain

Location

Instituto Valenciano De Oncologia

Valencia, Valencia, 46009, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Público Lluis Alcanyis

Xàtiva, Valencia, 46800, Spain

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

rucaparib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Results Point of Contact

• Title: President
• Organization: Grupo Español de Investigación en Cáncer de Ovario

ensayos@sorpromed.com

648495298

Study Officials

• Alfonso Yubero, Dr.

  Hospital Clínico Universitario Lozano Blesa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: September 7, 2020
• Study Start: July 29, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: March 18, 2026
• Results First Posted: March 18, 2026

Record last verified: 2026-02

Locations

ES (23)