Actively Recruiting
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
Led by North Eastern German Society of Gynaecological Oncology · Updated on 2026-02-12
640
Participants Needed
47
Research Sites
416 weeks
Total Duration
On this page
Sponsors
N
North Eastern German Society of Gynaecological Oncology
Lead Sponsor
I
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, age 18 years or older
- Diagnosed with FIGO Stage III-IV high-grade ovarian cancer (excluding mucinous histology), fallopian tube cancer, primary peritoneal cancer, or clear cell carcinoma
- Complete tumor removal with no visible residual tumor confirmed by CT scan
- HRD-positive tumor confirmed by genetic testing
- ECOG performance status of 0 or 1
- Able to take oral medications
- Synchronous or secondary cancers allowed if ovarian cancer prognosis is unaffected
- Normal organ and bone marrow function with specific blood count and biochemistry levels
- Postmenopausal or non-childbearing status for women of childbearing potential with negative pregnancy test
- Agree to practice highly effective contraception during treatment and for specified period after treatment
You will not qualify if you...
- Non-epithelial ovarian, fallopian tube, or peritoneal tumors or low malignant potential tumors
- Low-grade ovarian, fallopian tube, or peritoneal cancer
- Known allergy to study drugs or excipients
- Allergy to platinum compounds other than carboplatin
- Previous bone marrow transplant
- Underwent interval debulking surgery
- Received prior cancer therapy for ovarian cancer other than surgery
- Concurrent chemotherapy, anti-cancer therapy, or radiotherapy during study
- Prior treatment with PARP inhibitors
- Planned treatment with Bevacizumab
- Significant cardiovascular disease or recent serious cardiac events
- History or presence of brain metastases or spinal cord compression
- History or risk of certain blood disorders
- Current bowel obstruction or gastrointestinal disorders affecting drug absorption
- Pregnant or lactating women or unwillingness to use contraception
- Recent participation in other investigational drug studies
- Known HIV, Hepatitis B or C infection
- Active COVID-19 infection
- Recent live vaccine administration
- Contraindications per latest drug information
- Dependency on study personnel or incarceration/involuntary institutionalization in Germany
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 47 locations
1
Universitätsklinik Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
2
Cliniques Universitaires St. Luc
Brussels, Belgium
Active, Not Recruiting
3
UZ Gent
Ghent, Belgium
Not Yet Recruiting
4
Jessa ziekenhuis
Hasselt, Belgium
Not Yet Recruiting
5
UZ Leuven
Leuven, Belgium
Active, Not Recruiting
6
University Hospital Ostrava
Ostrava, Czechia
Active, Not Recruiting
7
General University Hospital in Prague
Prague, Czechia
Actively Recruiting
8
University Hospital Bulovka
Prague, Czechia
Active, Not Recruiting
9
Universitätsklinikum Aachen
Aachen, Germany, 52074
Actively Recruiting
10
Klinikum Mittelbaden Baden-Baden Bühl
Baden-Baden, Germany
Not Yet Recruiting
11
DRK-Kliniken Berlin-Köpenick
Berlin, Germany, 12559
Actively Recruiting
12
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, Germany, 13353
Actively Recruiting
13
ZAHO Bonn Onkologische Praxis
Bonn, Germany, 53115
Active, Not Recruiting
14
Uniklinikum Bonn
Bonn, Germany
Active, Not Recruiting
15
Klinikum Lippe
Detmold, Germany
Actively Recruiting
16
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Active, Not Recruiting
17
Florence-Nightingale-Krankenhaus Düsseldorf-Kaiserswerth
Düsseldorf, Germany
Active, Not Recruiting
18
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Active, Not Recruiting
19
Universitätsklinik Göttingen
Göttingen, Germany
Active, Not Recruiting
20
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Active, Not Recruiting
21
SLK-Kliniken Heilbronn
Heilbronn, Germany
Not Yet Recruiting
22
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany
Active, Not Recruiting
23
Universitätsklinikum Leipzig
Leipzig, Germany
Active, Not Recruiting
24
Universitätsklinik der Johannes-Gutenberg Universität Mainz
Mainz, Germany, 55131
Active, Not Recruiting
25
Diakonie Klinikum Schwäbisch Hall
Schwäbisch Hall, Germany
Actively Recruiting
26
Christliches Klinikum Unna Mitte
Unna, Germany, 59423
Active, Not Recruiting
27
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, Germany, 65199
Actively Recruiting
28
Policlinico St. Orsola Malpighi
Bologna, Italy
Active, Not Recruiting
29
ASST Spedali Civili di Brescia
Brescia, Italy
Active, Not Recruiting
30
ASST Lecco - Ospedale A. Manzoni
Lecco, Italy
Not Yet Recruiting
31
IRCCS Istituto nazionale dei Tumori
Milan, Italy
Not Yet Recruiting
32
AOU Cagliari
Monserrato, Italy
Not Yet Recruiting
33
Istituto Oncologico Veneto (IOV)
Padova, Italy
Active, Not Recruiting
34
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
Active, Not Recruiting
35
Azienda USL IRCCS Di Reggio Emilia
Reggio Emilia, Italy
Active, Not Recruiting
36
AO Ordine Mauriziano
Torino, Italy
Active, Not Recruiting
37
AOU Città della Salute e della Scienza di Torino - Ospedale Sant'Anna
Torino, Italy
Not Yet Recruiting
38
Hospital General Universitario Dr. Balmis
Alicante, Spain
Active, Not Recruiting
39
Hospital Virgen de las Nieves
Granada, Spain
Active, Not Recruiting
40
Hospital Universitario Lucus Augusti
Lugo, Spain
Active, Not Recruiting
41
CIOCC Clara Campal
Madrid, Spain
Active, Not Recruiting
42
H. Althaia Manresa
Manresa, Spain
Active, Not Recruiting
43
H.U. Virgen de la Macarena
Seville, Spain
Active, Not Recruiting
44
Hospital Universitario Virgen del Rocío
Seville, Spain
Active, Not Recruiting
45
Hospital Universitario Sant Joan de Reus
Tarragona, Spain
Active, Not Recruiting
46
Hospital General Universitario de Valencia
Valencia, Spain
Actively Recruiting
47
Hospital La Fe
Valencia, Spain
Active, Not Recruiting
Research Team
J
Jessica Nguyen
CONTACT
J
Jasmin Yamamoto
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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