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Clinical Trials in Spain / NCT05460000
Recruiting Phase 2

A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy

NCT05460000 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2024-10-11
Last updated
2026-07-27

Condition(s) studied

Ovarian CancerFallopian Tube CancerPrimary Peritoneal CarcinomaClear Cell Carcinoma

Investigational drug(s) / intervention(s)

3 cycles chemotherapy instead of 6 cycles chemotherapy6 cycles chemotherapy

3 cycles chemotherapy instead of 6 cycles chemotherapy: We hypothesise that recurrence free survival in patients receiving 3 cycles of chemotherapy followed by maintenance with niraparib is not inferior to 6 cycles of chemotherapy followed by niraparib in advanced HRDpositive high-grade ovarian cancer patients with no residual tumor mass following primary tumor debulking.

6 cycles chemotherapy: Standard chemotherapy as comparator

Study summary

Multicenter, randomized, open label study including patients with advanced HRDpositive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass following primary tumor debulking to determine recurrence free survival in patients treated with 3 cycles carboplatin + paclitaxel and maintenance therapy with niraparib vs. 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Written informed consent and obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. 2. Female patient, age ≥ 18 years. 3. FIGO Stage III-IV high-grade ovarian cancer (all histological types, except mucinous histology) 4. Complete primary debulked patients (without any macroscopic residuals), confirmed by CT-Scan postoperatively. 5. Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary cancer for central NGS analysis and must be HRDpositive defined as BRCAmut independent of NOGGO GIS Score OR NOGGO GIS Score \>83 independent of BRCA status, based on these results. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7. Patients must be able to take oral medications. 8. Synchronous and secondary malignancies are allowed if the prognosis of the ovarian cancer is not affected. The investigator must contact the medical monitoring team before enrolling the patient in the clinical trial. 9. Patients must have normal organ and bone marrow function: 1. Hemoglobin ≥ 10.0 g/dL independent of transfusion ≤ 14 days prior to screening hemoglobin assessment 2. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L 3. Platelet count ≥ 100 x 109/L 4. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); \< 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome 5. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2,5 x ULN 6. Serum creatinine ≤ 1.5 x institutional ULN and creatinine clearance \> 30 mL/min. 10. Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment. Female patients of childbearing potential must have a negative serum pregnancy test result ≤3 days prior to administration of the first dose of study treatment. Patients are considered to be of childbearing potential unless 1 of the following applies: 1. Considered to be permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy; or 2. Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level consistently in the postmenopausal range (30 mIU/mL or higher) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to confirm a postmenopausal state. Female patients of reproductive potential must practice highly effective methods (failure rate \< 1% per year) of contraception with their partners, if of reproductive potential, during treatment and for 6 months following the last dose of chemotherapy or the last dose of niraparib, whichever occurs later, or longer if requested by local authorities. Highly effective contraception includes: Ongoing use of progesterone only injectable or implantable contraceptives; Placement of an intrauterine device (IUD) or intrauterine system (IUS); Bilateral tubal occlusion; Sexual abstinence as defined as complete or true abstinence, acceptable only when it is the usual and preferred lifestyle of the patient; periodic abstinence (e.g., calendar, symptothermal, post-ovulation methods) is not acceptable; or Sterilization of the male partner, with appropriate post-vasectomy documentation of absence of sperm in ejaculate. Exclusion Criteria: 1. Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e., germ cell tumors) and Ovarian tumors of low malignant potential (e.g., borderline tumors), or mucinous carcinoma of the ovary. 2. Low-grade ovarian, fallopian tube or peritoneal cancer. 3. Has known hypersensitivity to any of the study drugs or any of the excipients of any of the study drugs. 4. Has known hypersensitivity to platin-containing compounds other than carboplatin. 5. Patients posttransplant, including previous allogeneic bone marrow transplant. 6. Has undergone interval debulking of the tumor. 7. Has received any anti-cancer therapy for ovarian cancer other than primary surgery. 8. Administration of other simultaneous chemotherapy drugs, any other anti-cancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics). 9. Has received prior treatment with a PARP inhibitor or has participated in a trial where any treatment arm included the administration of a PARP inhibitor. 10. Bevacizumab is planned to be given together with first line chemotherapy or as maintenance. 11. Clinically significant cardiovascular disease: 1. Cerebrovascular accident or myocardial infarction or unstable angina ≤6 months before start of study treatment 2. Severe cardiac arrhythmia (recent event or active or uncontrolled) 3. New York Heart Association grade ≥2 congestive heart failure 4. Uncontrolled hypertension (defined as systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy or posterior reversible encephalopathy syndrome 5. History of stroke or transient ischemic attack ≤6 months before start of study treatment 6. Coronary/peripheral artery bypass graft ≤6 months before start of study treatment 7. Deep vein thrombosis or thromboembolic events ≤1 month before start of study treatment 12. History or evidence of brain metastases or spinal cord compression. 13. Known history of MDS or a pre-treatment cytogenetic testing result at risk for a diagnosis of MDS/AML. 14. Current, clinically relevant bowel obstruction at the time of randomization. 15. Patients with gastrointestinal disorders likely to interfere with absorption of the study medication. 16. Pregnant or lactating women, women of child-bearing potential who do not agree to the usage of highly effective contraception methods (see inclusion criteria) starting with the screening visit through at least 6 months after the last dose of chemotherapy treatment or through at least 1 month after the last dose of niraparib, whichever occurs later. 17. Participation in another clinical study with an investigational product immediately prior to randomization. Earliest time point for randomization is after the time required for the investigational product to undergo 5 half-lives has passed. 18. Has a known history of Human Immunodeficiency Virus (HIV) infection (known HIV1/HIV2 antibodies positive) or acquired immunodeficiency syndrome (AIDS) related illness. 19. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] has been detected) infection. 20. Has active infection with SARS-CoV-2 (antigen test). 21. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of chemotherapy treatment and while and 28 days after the last dose of trial treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. Administration of inactivated vaccines is allowed. 22. Patient has contraindications listed in the most recent SmPC. 23. Patient who might be dependent on the sponsor, CRO, site or the investigator. 22\. In Germany: Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40a S. 1 Nr. 2 AMG.

Primary outcome measure(s)

Trial sites (50)

FacilityCityRegionStatus
Universitätsklinik Innsbruck Innsbruck Austria Recruiting
Cliniques Universitaires St. Luc Brussels Belgium Active Not Recruiting
UZ Gent Ghent Belgium Active Not Recruiting
Jessa ziekenhuis Hasselt Belgium Recruiting
UZ Leuven Leuven Belgium Active Not Recruiting
University Hospital Ostrava Ostrava Czechia Recruiting
General University Hospital in Prague Prague Czechia Recruiting
University Hospital Bulovka Prague Czechia Active Not Recruiting
Universitätsklinikum Aachen Aachen Germany Recruiting
Klinikum Mittelbaden Baden-Baden Bühl Baden-Baden Germany Not Yet Recruiting
DRK-Kliniken Berlin-Köpenick Berlin Germany Recruiting
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum Berlin Germany Recruiting
ZAHO Bonn Onkologische Praxis Bonn Germany Active Not Recruiting
Uniklinikum Bonn Bonn Germany Recruiting
Universitätsklinikum Köln Cologne Germany Not Yet Recruiting
Klinikum Lippe Detmold Germany Recruiting
Klinikum Dortmund - Klinikum der Universität Witten Herdecke Dortmund Germany Active Not Recruiting
Universitätsklinikum Carl Gustav Carus Dresden Germany Recruiting
Florence-Nightingale-Krankenhaus Düsseldorf-Kaiserswerth Düsseldorf Germany Active Not Recruiting
Universitätsklinikum Freiburg Freiburg im Breisgau Germany Active Not Recruiting
Universitätsklinik Göttingen Göttingen Germany Active Not Recruiting
Universitätsklinikum Hamburg-Eppendorf Hamburg Germany Active Not Recruiting
SLK-Kliniken Heilbronn Heilbronn Germany Not Yet Recruiting
Universitätsklinikum Schleswig-Holstein Campus Kiel Kiel Germany Recruiting
Universitätsklinikum Leipzig Leipzig Germany Recruiting
Universitätsklinik der Johannes-Gutenberg Universität Mainz Mainz Germany Active Not Recruiting
Klinikum Dritter Orden München Germany Not Yet Recruiting
Diakonie Klinikum Schwäbisch Hall Schwäbisch Hall Germany Recruiting
Christliches Klinikum Unna Mitte Unna Germany Recruiting
Helios Dr. Horst Schmidt Kliniken Wiesbaden Wiesbaden Germany Recruiting
Policlinico St. Orsola Malpighi Bologna Italy Recruiting
ASST Spedali Civili di Brescia Brescia Italy Recruiting
ASST Lecco - Ospedale A. Manzoni Lecco Italy Active Not Recruiting
IRCCS Istituto nazionale dei Tumori Milan Italy Recruiting
AOU Cagliari Monserrato Italy Not Yet Recruiting
Istituto Oncologico Veneto (IOV) Padova Italy Recruiting
Azienda Ospedaliera Universitaria Pisana Pisa Italy Active Not Recruiting
Azienda USL IRCCS Di Reggio Emilia Reggio Emilia Italy Active Not Recruiting
AO Ordine Mauriziano Torino Italy Recruiting
AOU Città della Salute e della Scienza di Torino - Ospedale Sant'Anna Torino Italy Recruiting

+ 10 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05460000 on ClinicalTrials.gov ↗ ← All trials in Spain