Clinical trial • Phase III • Oncology

NIRAPARIB TOSILATE MONOHYDRATE for Advanced ovarian cancer | Peritoneal carcinoma | Fallopian tube cancer

Phase III trial of NIRAPARIB TOSILATE MONOHYDRATE for Advanced ovarian cancer | Peritoneal carcinoma | Fallopian tube cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced ovarian cancer | Peritoneal carcinoma | Fallopian tube cancer
Trial Stage
Phase III
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
25-10-2024
First CTIS Authorization Date
02-12-2024

Trial design

Randomised, two regimen arms: 1) carboplatin + paclitaxel + bevacizumab followed by bevacizumab and niraparib; 2) carboplatin + paclitaxel followed by niraparib. doses recorded in product entries: carboplatin (max daily dose amount 400 mg/m2), paclitaxel (max daily dose amount 175 mg/m2), bevacizumab (max daily dose amount 15 mg/kg), niraparib (max daily dose amount 300 mg). specific treatment schedules not specified in the ctis data provided.-controlled Phase III trial in Germany, Belgium, Italy.

Randomised
Yes
Comparator
Two regimen arms: 1) carboplatin + paclitaxel + bevacizumab followed by bevacizumab and niraparib; 2) carboplatin + paclitaxel followed by niraparib. Doses recorded in product entries: carboplatin (max daily dose amount 400 mg/m2), paclitaxel (max daily dose amount 175 mg/m2), bevacizumab (max daily dose amount 15 mg/Kg), niraparib (max daily dose amount 300 mg). Specific treatment schedules not specified in the CTIS data provided.
Biomarker Stratified
True, biomarker: tumor BRCA (tBRCA) status (presence vs absence of a deleterious/suspected deleterious mutation)
Target Sample Size
1063

Stratification factors

  • tBRCA status

Eligibility

Recruits 1063 Vulnerable population selected (isVulnerablePopulationSelected: true). Informed consent: "Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the clinical trial requirements". Women of childbearing potential require negative highly sensitive urine or serum pregnancy test within 7 days prior to day 1 cycle 1 and agreement to use highly effective contraception or abstinence during treatment and for at least 6 months after last dose (see inclusion criteria). No assent provisions for minors (trial includes adults ≥ 18 years)..

Pregnancy Exclusion
Pregnant or lactating women.
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected: true). Informed consent: "Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the clinical trial requirements". Women of childbearing potential require negative highly sensitive urine or serum pregnancy test within 7 days prior to day 1 cycle 1 and agreement to use highly effective contraception or abstinence during treatment and for at least 6 months after last dose (see inclusion criteria). No assent provisions for minors (trial includes adults ≥ 18 years).

Inclusion criteria

  • {"criterion_text":"- Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the clinical trial requirements"}
  • {"criterion_text":"- Adequate liver and kidney function (within 28 days prior to day 1, cycle 1 and within 3 days prior to day 1, cycle 2): Total bilirubin ≤ 1.5 x ULN (≤ 2.0 x ULN in patients with known Gilbert’s syndrome) OR direct bilirubin ≤ 1.0 x ULN; Aspartate aminotransferase / Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT) and Alanine aminotransferase / Serum Glutamic Pyruvate Transaminase (ALAT/SGPT) ≤ 2.5 x ULN, unless liver metastases are present, in case of liver metastases values must be ≤ 5 x ULN; Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24 hour urine must demonstrate ≤ 1 g of protein in 24 hours; Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 30 mL/min"}
  • {"criterion_text":"- Patients must have normal blood pressure (BP) or adequately treated and controlled BP, with a systolic BP of ≤ 140 mmHg and diastolic BP of ≤ 90 mmHg for eligibility. Patients must have a BP of ≤ 140/90 mmHg taken in the clinic setting by a medical professional within 4 weeks prior to day 1, cycle 1 and within 7 days prior to day 1, cycle 2"}
  • {"criterion_text":"- Negative highly sensitive urine or serum pregnancy test within 7 days prior to day 1, cycle 1 in women of childbearing potential (WOCBP), confirmed prior to treatment on day 1"}
  • {"criterion_text":"- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 6 months after administration of the last dose of medication. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include but are not limited to bilateral tubal ligation and/or occlusion, male sterilization, and intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception"}
  • {"criterion_text":"- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other clinical trial procedures, that include the completion of patient-reported outcomes questionnaires"}
  • {"criterion_text":"- Female patients ≥ 18 years with histologically confirmed primary advanced invasive high grade non- mucinous, non-clear cell epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer FIGO III/IV (except FIGO IIIA2 without nodal involvement) according to recent FIGO classification (= FIGO IIIB-IV according to FIGO 2009 classification)"}
  • {"criterion_text":"- All patients must have had either upfront primary debulking surgery OR plan to undergo chemotherapy with interval debulking surgery"}
  • {"criterion_text":"- Patients must have available tumor samples to be sent to central laboratory as formalin fixed, paraffin-embedded (FFPE) sample for determination of BRCA status prior to randomization for stratification"}
  • {"criterion_text":"- Patients must be able to commence systemic therapy within 8 weeks of cytoreductive surgery"}
  • {"criterion_text":"- ECOG performance status (PS) 0-1"}
  • {"criterion_text":"- Estimated life expectancy > 3 months"}
  • {"criterion_text":"- Adequate bone marrow function (within 28 days prior to day 1, cycle 1 and within 3 days prior to day 1, cycle 2): Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9 /L, Platelets (PLT) ≥ 100 x 10^9 /L, Hemoglobin (Hb) ≥ 9 g/dL (can be post-transfusion)"}

Exclusion criteria

  • {"criterion_text":"- Non-epithelial tumor origin of the ovary"}
  • {"criterion_text":"- History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to day 1, cycle 1) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to day 1, cycle 1) in case of suspected spinal cord compression."}
  • {"criterion_text":"- Significant traumatic injury like a major surgery during 4 weeks preceding the potential first dose of bevacizumab."}
  • {"criterion_text":"- Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to day 1, cycle 1."}
  • {"criterion_text":"- History or evidence of major thrombotic (e.g. symptomatic pulmonary embolism) or hemorrhagic disorders within 3 months prior to day 1, cycle 1."}
  • {"criterion_text":"- History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy e.g. uncontrolled seizures."}
  • {"criterion_text":"- Pregnant or lactating women."}
  • {"criterion_text":"- Treatment with any other investigational agent, or participation in another clinical trial testing a drug within 4 weeks or 5 times the half-life of the drug, whichever is longer, prior to day 1, cycle 1 or concomitantly within this trial."}
  • {"criterion_text":"- Known hypersensitivity to bevacizumab and its excipients, Chinese hamster ovary cell products or other recombinant human or humanized antibodies. Known hypersensitivity to niraparib, paclitaxel and carboplatin and its components or excipients."}
  • {"criterion_text":"- Non-healing wound, active ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no severe evidence of facial dehiscence or infection are eligible; regular wound examination will be performed."}
  • {"criterion_text":"- Clinically significant cardiovascular disease, including Myocardial infarction or unstable angina within 6 months of day 1, cycle 1, New York Heart Association (NYHA, see Appendix 3) Grade 2 Congestive Heart Failure (CHF), Poorly controlled cardiac arrhythmia despite medication (patients with rate-controlled atrial fibrillation are eligible), Grade ≥ 3 peripheral vascular disease (i.e. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision), Significant vascular disease including aortic aneurysm requiring surgical repair."}
  • {"criterion_text":"- Ovarian tumors of low malignant potential (e.g. borderline tumors) and low grade tumors"}
  • {"criterion_text":"- Pre-existing sensory or motor neuropathy ≥ Grade 2."}
  • {"criterion_text":"- (Intentionally left blank)"}
  • {"criterion_text":"- Patients with a history of or current Nephrotic syndrome."}
  • {"criterion_text":"- Persistent cancer-related bowel obstruction (including subocclusive disease). Patients with a known history of ileus, who have been successfully treated and who are free of symptoms, may be eligible after consultation of sponsor."}
  • {"criterion_text":"- History of abdominal fistula or tracheoesophageal fistula or gastrointestinal perforation or active gastrointestinal bleeding or anastomotic insufficiency or intraabdominal abscess within 6 months of day 1, cycle 1."}
  • {"criterion_text":"- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of niraparib."}
  • {"criterion_text":"- Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications."}
  • {"criterion_text":"- Any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)."}
  • {"criterion_text":"- Previous allogeneic bone marrow transplant or previous solid organ transplantation."}
  • {"criterion_text":"- Current or recent (within 10 days prior to day 1, cycle 1) chronic use of aspirin > 325 mg/day. Patients treated with other inhibitors of platelet aggregation such as clopidogrel, prasugrel, ticlopidine, tirofibane or dipyridamole should not be included into the trial."}
  • {"criterion_text":"- Planned intraperitoneal cytotoxic chemotherapy"}
  • {"criterion_text":"- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. This includes also any psychiatric disorder that prohibits obtaining informed consent.."}
  • {"criterion_text":"- Patient has known active hepatitis B or hepatitis C."}
  • {"criterion_text":"- Patient has a history of Posterior Reversible Encephalopathy Syndrome (PRES)."}
  • {"criterion_text":"- Patients with chronic inflammatory bowel disease and active treatment for disease control."}
  • {"criterion_text":"- Malignancies other than ovarian cancer within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ of the breast, or stage I p53 wild type endometrial cancer)"}
  • {"criterion_text":"- Prior systemic treatment for ovarian cancer"}
  • {"criterion_text":"- Prior treatment with PARP inhibitor"}
  • {"criterion_text":"- Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted)"}
  • {"criterion_text":"- Prior randomization in AGO-OVAR 28"}
  • {"criterion_text":"- Major surgery within 7 days prior to day 1, cycle 1 or patient who has not completely recovered from the effects of any major surgery. Core biopsy or other minor surgical procedure within 7 days prior to day 1, cycle 1 is permitted."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS will be defined as the time from randomization to first progressive disease (PD) or death, whichever occurs earlier. PD is based on investigators assessment using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).","definition_or_measurement_approach":"Progression-free survival (PFS): time from randomization to first progressive disease (PD) or death; PD assessed by investigators using RECIST v1.1"}

Secondary endpoints

  • {"endpoint_text":"- PFS in subgroups defined by tBRCA status (presence or absence of a deleterious/suspected deleterious mutation)","definition_or_measurement_approach":"PFS as defined for primary endpoint, analysed by tumor BRCA (tBRCA) status (presence vs absence of deleterious/suspected deleterious mutation)"}
  • {"endpoint_text":"- OS (time from randomization to death), TFST (time from randomization to the first subsequent treatment or death, whichever occurs earlier), PFS2 (time from randomization to the second progression or death, whichever occurs earlier), TSST (time from randomization to the second subsequent treatment or death, whichever occurs earlier)","definition_or_measurement_approach":"Overall survival (OS): time from randomization to death; TFST, PFS2, TSST defined as stated in endpoint description"}
  • {"endpoint_text":"- Safety and tolerability evaluated by AEs / SAEs, physical examination, vital signs including BP, heart rate, and laboratory findings including clinical chemistry / hematology parameters.","definition_or_measurement_approach":"Safety assessed by adverse events (AEs/SAEs), physical exams, vital signs (including BP, heart rate) and laboratory parameters (clinical chemistry/hematology)"}
  • {"endpoint_text":"- Effects on Quality of life (QoL) assessed by EORTC QLQ-C30 (functional and HRQoL scales), QLQ-OV-28 questionnaires (items 31 to 36 from the abdominal/GI symptoms subscale), Patient reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)","definition_or_measurement_approach":"QoL assessed by EORTC QLQ-C30, QLQ-OV-28 (specified items), and PRO-CTCAE patient-reported outcome measures"}

Recruitment

Planned Sample Size
1063
Recruitment Window Months
111
Consent Approach
Signed written informed consent obtained from each participant prior to any study-specific procedures. Consent documents available for publication include subject information and informed consent forms in English, Dutch, French (documents titled L1_SIS and ICF adults_EN, _NL, _FR) and German versions for the main trial (L1_SIS and ICF_MainTrial_redacted V07F). Participants are adults (≥18 years); no assent for minors is described.

Geography

Total Number Of Sites
85
Total Number Of Participants
1063

Germany

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
664
Number Of Sites
75
Number Of Participants
970

Sites

Site Name
MVZ Onko Medical GmbH
Department Name
Gynäkologisch-Onkologische Praxis am Pelikanplatz
Principal Investigator Name
Hans-Joachim Lueck
Principal Investigator Email
hlueck@goph.de
Contact Person Name
Hans-Joachim Lueck
Contact Person Email
hlueck@goph.de
Site Name
Philipps-Universitaet Marburg
Department Name
Frauenklinik am Klinikum Fulda
Principal Investigator Name
Ulrich Bonse-Geuking
Principal Investigator Email
ulrich.bonse-geuking@klinikum-fulda.de
Contact Person Name
Ulrich Bonse-Geuking
Site Name
St. Vincenz-Krankenhaus GmbH
Department Name
Frauenklinik St. Louise - St. Vincenz Krankenhaus GmbH
Principal Investigator Name
Maren Klee
Principal Investigator Email
m.klee@vincenz.de
Contact Person Name
Maren Klee
Contact Person Email
m.klee@vincenz.de
Site Name
St. Josefs-Hospital Wiesbaden GmbH
Department Name
Gynäkologische Onkologie
Principal Investigator Name
Antje Lehnert
Principal Investigator Email
alehnert@joho.de
Contact Person Name
Antje Lehnert
Contact Person Email
alehnert@joho.de
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik für Gynäkologie & Gynäkologische Onkologie
Principal Investigator Name
Florian Heitz
Principal Investigator Email
f.heitz@kem-med.com
Contact Person Name
Florian Heitz
Contact Person Email
f.heitz@kem-med.com
Site Name
Kreiskliniken Reutlingen gGmbH
Department Name
Frauenklinik
Principal Investigator Name
Lars Norrenberg
Principal Investigator Email
lars.norrenberg@kliniken-rt.de
Contact Person Name
Lars Norrenberg
Contact Person Email
lars.norrenberg@kliniken-rt.de
Site Name
Klinikum St Marien Amberg
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Thomas Papathemelis
Principal Investigator Email
papathemelis.thomas@klinikum-amberg.de
Contact Person Name
Thomas Papathemelis
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Bahriye Aktas
Principal Investigator Email
bahriye.aktas@medizin.uni-leipzig.de
Contact Person Name
Bahriye Aktas
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Tjoung-Won Park-Simon
Principal Investigator Email
park-simon.tjoung-won@mh-hannover.de
Contact Person Name
Tjoung-Won Park-Simon
Site Name
Klinikum Hanau GmbH
Department Name
Klinik für Gynäkologie und Geburtshilfe
Principal Investigator Name
Jens Kosse
Principal Investigator Email
Jens_Kosse@Klinikum-Hanau.de
Contact Person Name
Jens Kosse
Contact Person Email
Jens_Kosse@Klinikum-Hanau.de
Site Name
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
Department Name
Klinik für Onkologie und Hämatologie
Principal Investigator Name
Nicolas Moosmann
Principal Investigator Email
nicolas.moosmann@barmherzige-regensburg.de
Contact Person Name
Nicolas Moosmann
Site Name
St. Elisabeth Krankenhaus GmbH
Department Name
Gynaekologie/Geburtshilfe
Principal Investigator Name
Daniel Rein
Principal Investigator Email
daniel.rein@hohenlind.de
Contact Person Name
Daniel Rein
Contact Person Email
daniel.rein@hohenlind.de
Site Name
Onkologische Schwerpunktpraxis
Department Name
Onkologische Schwerpunktpraxis Bielefeld
Principal Investigator Name
Siemke Steinke
Principal Investigator Email
studien@onkologie-bielefeld.de
Contact Person Name
Siemke Steinke
Contact Person Email
studien@onkologie-bielefeld.de
Site Name
National Center For Tumor Diseases (NCT) Heidelberg
Department Name
Gynecology and Obstetrics
Principal Investigator Name
Oliver Zivanovic
Principal Investigator Email
oliver.zivanovic@med.uni-heidelberg.de
Contact Person Name
Oliver Zivanovic
Site Name
Johannes Wesling Klinikum Minden
Department Name
Hämatologie / Onkologie
Principal Investigator Name
Martin Griesshammer
Contact Person Name
Martin Griesshammer
Site Name
Kaiserswerther Diakonie
Department Name
Klinik für Gynäkologie und Geburtshilfe
Principal Investigator Name
Saher Baransi
Principal Investigator Email
karpman@kaiserswerther-diakonie.de
Contact Person Name
Saher Baransi
Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
Frauenklinik
Principal Investigator Name
Stefanie Krueger-Rehberg
Principal Investigator Email
stefanie.krueger-rehberg@srh.de
Contact Person Name
Stefanie Krueger-Rehberg
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Frauenklinik
Principal Investigator Name
Ulrich Karck
Principal Investigator Email
u.karck@klinikum-stuttgart.de
Contact Person Name
Ulrich Karck
Contact Person Email
u.karck@klinikum-stuttgart.de
Site Name
Klinikum Frankfurt Hoechst GmbH
Department Name
Klinik für Gynäkologie
Principal Investigator Name
Joachim Rom
Principal Investigator Email
joachim.rom@varisano.de
Contact Person Name
Joachim Rom
Contact Person Email
joachim.rom@varisano.de
Site Name
Universitaetsklinikum Augsburg
Department Name
Frauenklinik
Principal Investigator Name
Christian Dannecker
Principal Investigator Email
christian.dannecker@med.uni-augsburg.de
Contact Person Name
Christian Dannecker
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Franziska Hemptenmacher
Principal Investigator Email
franziska.hemptenmacher@uksh.de
Contact Person Name
Franziska Hemptenmacher
Site Name
Mammazentrum Hamburg MVZ GbR
Department Name
Gynäkologisches und Onkologisches Therapie- und Operationszentrum
Principal Investigator Name
Linn Woelber
Principal Investigator Email
l.woelber@uke.de
Contact Person Name
Linn Woelber
Contact Person Email
l.woelber@uke.de
Site Name
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH
Department Name
Frauenklinik und Geburtshilfe
Principal Investigator Name
Elke Wiegand
Principal Investigator Email
ewiegand@leopoldina.de
Contact Person Name
Elke Wiegand
Contact Person Email
ewiegand@leopoldina.de
Site Name
Klinikum Guetersloh gGmbH
Department Name
Frauenklinik
Principal Investigator Name
Wencke Ruhwedel
Principal Investigator Email
wencke.ruhwedel@klinikum-guetersloh.de
Contact Person Name
Wencke Ruhwedel
Site Name
Universitaetsklinikum Magdeburg AöR
Department Name
Universitätsklinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin
Principal Investigator Name
Atanas Ignatov
Principal Investigator Email
atanas.ignatov@med.ovgu.de
Contact Person Name
Atanas Ignatov
Contact Person Email
atanas.ignatov@med.ovgu.de
Site Name
Klinikum Dortmund gGmbH
Department Name
Frauenklinik
Principal Investigator Name
Sophie Kage
Principal Investigator Email
Sophie.Kage@klinikumdo.de
Contact Person Name
Sophie Kage
Contact Person Email
Sophie.Kage@klinikumdo.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Frauenheilkunde
Principal Investigator Name
Ingolf Juhasz-Böss
Principal Investigator Email
ingolf.juhasz-boess@uniklinik-freiburg.de
Contact Person Name
Ingolf Juhasz-Böss
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Fabienne Schochter
Principal Investigator Email
fabienne.schochter@uniklinik-ulm.de
Contact Person Name
Fabienne Schochter
Site Name
Kliniken des Landkreises Neumarkt i.d.Opf.
Department Name
Frauenklinik
Principal Investigator Name
Heinz Scholz
Principal Investigator Email
heinz.scholz@klinikum.neumarkt.de
Contact Person Name
Heinz Scholz
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Tanja Fehm
Principal Investigator Email
Tanja.Fehm@med.uni-duesseldorf.de
Contact Person Name
Tanja Fehm
Site Name
RoMed Klinikum Rosenheim
Department Name
Klinikum für Gynäkologie und Geburtshilfe
Principal Investigator Name
Andreas Schnelzer
Principal Investigator Email
Andreas.schnelzer@ro-med.de
Contact Person Name
Andreas Schnelzer
Contact Person Email
Andreas.schnelzer@ro-med.de
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Frauenklinik
Principal Investigator Name
Nikolaus de Gregorio
Principal Investigator Email
nikolaus.degregorio@slk-kliniken.de
Contact Person Name
Nikolaus de Gregorio
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Maximilian Rost
Principal Investigator Email
rost@med.uni-frankfurt.de
Contact Person Name
Maximilian Rost
Contact Person Email
rost@med.uni-frankfurt.de
Site Name
Klinikum Worms gGmbH
Department Name
Frauenklinik
Principal Investigator Name
Matthias Koegel
Principal Investigator Email
Matthias.Koegel@klinikum-worms.de
Contact Person Name
Matthias Koegel
Site Name
Gemeinschaftspraxis Dr. Pourfard & Dr. Uleer
Department Name
Praxis Dr. C. Uleer / Dr. J. Y. Pourfard
Principal Investigator Name
Christoph Uleer
Principal Investigator Email
info@frauenarzt-hildesheim.de
Contact Person Name
Christoph Uleer
Contact Person Email
info@frauenarzt-hildesheim.de
Site Name
Ortenau Klinikum
Department Name
Frauenklinik
Principal Investigator Name
Heidrun Maennle
Principal Investigator Email
heidrun.maennle@ortenau-klinikum.de
Contact Person Name
Heidrun Maennle
Site Name
Gynäkologie Kompetenzzentrum Stralsund Gynäkologische Praxis Dr. med. Carsten Hielscher
Department Name
g.SUND
Principal Investigator Name
Carsten Hielscher
Principal Investigator Email
hielscher@gyn-stralsund.de
Contact Person Name
Carsten Hielscher
Contact Person Email
hielscher@gyn-stralsund.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Fabian Trillsch
Principal Investigator Email
Fabian.Trillsch@med.uni-muenchen.de
Contact Person Name
Fabian Trillsch
Site Name
Staedtisches Klinikum Karlsruhe gGmbH
Department Name
Frauenklinik
Principal Investigator Name
Andreas Mueller
Principal Investigator Email
andreas.mueller.fk@klinikum-karlsruhe.de
Contact Person Name
Andreas Mueller
Site Name
HELIOS Klinikum Krefeld GmbH
Department Name
Zentrum für ambulante gynäkologische Onkologie
Principal Investigator Name
Marina Wirtz
Principal Investigator Email
marina.wirtz@helios-gesundheit.de
Contact Person Name
Marina Wirtz
Site Name
Klinikum Konstanz GmbH
Department Name
Frauenklinik
Principal Investigator Name
Andreas Zorr
Principal Investigator Email
andreas.zorr@glkn.de
Contact Person Name
Andreas Zorr
Contact Person Email
andreas.zorr@glkn.de
Site Name
Hochtaunus-Kliniken gGmbH
Department Name
Klinik für Gynäkologie und Geburtshilfe
Principal Investigator Name
Dominik Denschlag
Principal Investigator Email
dominik.denschlag@hochtaunus-kliniken.de
Contact Person Name
Dominik Denschlag
Site Name
RKH Klinken Ludwigsburg-Bietigheim gGmbH
Department Name
Gynäkologie
Principal Investigator Name
Claudia Haenle
Principal Investigator Email
claudia.haenle@rkh-kliniken.de
Contact Person Name
Claudia Haenle
Contact Person Email
claudia.haenle@rkh-kliniken.de
Site Name
Krankenhausgesellschaft St. Vincenz mbH
Department Name
Frauenklinik
Principal Investigator Name
Angelika Ober
Principal Investigator Email
a.ober@st-vincenz.de
Contact Person Name
Angelika Ober
Contact Person Email
a.ober@st-vincenz.de
Site Name
MVZ Nordhausen
Department Name
Frauenklinik und Brustzentrum
Principal Investigator Name
Andrea Grafe
Principal Investigator Email
Andrea.Grafe@shk-ndh.de
Contact Person Name
Andrea Grafe
Contact Person Email
Andrea.Grafe@shk-ndh.de
Site Name
Klinikum Kassel GmbH
Department Name
Frauenklinik
Principal Investigator Name
Gabriele Feisel-Schwickardi
Principal Investigator Email
gabriele.feisel@klinikum-kassel.de
Contact Person Name
Gabriele Feisel-Schwickardi
Site Name
Universitaetsklinikum Brandenburg an der Havel GmbH
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Cornelia Mueller
Principal Investigator Email
c.mueller@klinikum-brandenburg.de
Contact Person Name
Cornelia Mueller
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Annette Hasenburg
Principal Investigator Email
annette.hasenburg@unimedizin-mainz.de
Contact Person Name
Annette Hasenburg
Site Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Department Name
Gynäkologie
Principal Investigator Name
Sebastian Jud
Principal Investigator Email
eva.junk@mutterhaus.de
Contact Person Name
Sebastian Jud
Contact Person Email
eva.junk@mutterhaus.de
Site Name
Klinikverbund Allgaeu gGmbH
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Ricardo Felberbaum
Contact Person Name
Ricardo Felberbaum
Site Name
Klinikum Magdeburg gGmbH
Department Name
Hämatologie/Onkologie
Principal Investigator Name
Holm Eggemann
Principal Investigator Email
holm.eggemann@klinikum-magdeburg.de
Contact Person Name
Holm Eggemann
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik und Poliklinik für Gynaekologie
Principal Investigator Name
Barbara Schmalfeldt
Principal Investigator Email
b.schmalfeldt@uke.de
Contact Person Name
Barbara Schmalfeldt
Contact Person Email
b.schmalfeldt@uke.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Frauenheilkunde
Principal Investigator Name
Ivo Meinhold-Heerlein
Contact Person Name
Ivo Meinhold-Heerlein
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Universitätsklinik und Poliklinik für Gynäkologie
Principal Investigator Name
Markus Wallwiener
Principal Investigator Email
Markus.Wallwiener@uk-halle.de
Contact Person Name
Markus Wallwiener
Contact Person Email
Markus.Wallwiener@uk-halle.de
Site Name
MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum
Department Name
Studienzentrum Onkologie Ravensburg
Principal Investigator Name
Martina Gropp-Meier
Principal Investigator Email
Irina.Gossen@onkonet.eu
Contact Person Name
Martina Gropp-Meier
Contact Person Email
Irina.Gossen@onkonet.eu
Site Name
Thueringen-Kliniken Georgius Agricola GmbH
Department Name
Frauenklinik
Principal Investigator Name
Dietrich Hager
Principal Investigator Email
dhager@thueringen-kliniken.de
Contact Person Name
Dietrich Hager
Contact Person Email
dhager@thueringen-kliniken.de
Site Name
Klinikum Suedstadt Rostock Eigenbetrieb der Hanse und Universitaetsstadt Rostock
Department Name
Universitätsfrauenklinik und Poliklinik
Principal Investigator Name
Kristin Strauss
Principal Investigator Email
kristin.strauss@kliniksued-rostock.de
Contact Person Name
Kristin Strauss
Site Name
Rotkreuzklinikum Muenchen gGmbH
Department Name
Frauenklinik
Principal Investigator Name
Martin Poelcher
Principal Investigator Email
martin.poelcher@swmbrk.de
Contact Person Name
Martin Poelcher
Contact Person Email
martin.poelcher@swmbrk.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Fabinshy Thangarajah
Principal Investigator Email
studien.frauenklinik@uk-essen.de
Contact Person Name
Fabinshy Thangarajah
Site Name
Kliniken Suedostbayern AG
Department Name
Hämatologie-Onkologie-Palliativmedizin Klinikum Traunstein
Principal Investigator Name
Matthias Egger
Principal Investigator Email
matthias.egger@kliniken-sob.de
Contact Person Name
Matthias Egger
Contact Person Email
matthias.egger@kliniken-sob.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Frauenklinik
Principal Investigator Name
Paul Gaß
Principal Investigator Email
paul.gass.studien@skc.de
Contact Person Name
Paul Gaß
Contact Person Email
paul.gass.studien@skc.de
Site Name
Albertinen-Krankenhaus/Albertinen-Haus gGmbH
Department Name
Gynäkologie
Principal Investigator Name
Ulrike Doerste
Principal Investigator Email
ulrike.doerste@albertinen.de
Contact Person Name
Ulrike Doerste
Contact Person Email
ulrike.doerste@albertinen.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin
Principal Investigator Name
Dirk Bauerschlag
Principal Investigator Email
huyenthithanh.nguyen@med.uni-jena.de
Contact Person Name
Dirk Bauerschlag
Site Name
ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG
Department Name
Frauenklinik
Principal Investigator Name
Oliver Tomé
Principal Investigator Email
oliver.tome@vincentius-ka.de
Contact Person Name
Oliver Tomé
Contact Person Email
oliver.tome@vincentius-ka.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Gynäkologie mit Zentrum für onkologische Chirurgie
Principal Investigator Name
Klaus Pietzner
Principal Investigator Email
klaus.pietzner@charite.de
Contact Person Name
Klaus Pietzner
Contact Person Email
klaus.pietzner@charite.de
Site Name
Universitaetsklinikum Koeln AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Gyn. Onkologie
Principal Investigator Name
Florin-Andrei Taran
Principal Investigator Email
florin-andrei.taran@uk-koeln.de
Contact Person Name
Florin-Andrei Taran
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Klinik für Gynäkologie und Senologie
Principal Investigator Name
Mustafa Aydogdu
Principal Investigator Email
mustafa.aydogdu@klinikum-bremen-mitte.de
Contact Person Name
Mustafa Aydogdu
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Frauenklinik
Principal Investigator Name
Frederik Marmé
Principal Investigator Email
frederik.marme@umm.de
Contact Person Name
Frederik Marmé
Contact Person Email
frederik.marme@umm.de
Site Name
Philipps-Universitaet Marburg
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Niklas Gremke
Principal Investigator Email
gremken@staff.uni-marburg.de
Contact Person Name
Niklas Gremke
Contact Person Email
gremken@staff.uni-marburg.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Department für Frauengesundheit/Universitäts-Frauenklinik
Principal Investigator Name
Andreas Hartkopf
Principal Investigator Email
andreas.hartkopf@med.uni-tuebingen.de
Contact Person Name
Andreas Hartkopf
Site Name
Staedtisches Krankenhaus Kiel GmbH
Department Name
Frauenklinik
Principal Investigator Name
Julia Schulze
Principal Investigator Email
julia.schulze@krankenhaus-kiel.de
Contact Person Name
Julia Schulze
Site Name
Klinikum Esslingen GmbH
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Alexander Hein
Principal Investigator Email
a.hein.cto@klinikum-esslingen.de
Contact Person Name
Alexander Hein
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Ralf Witteler
Principal Investigator Email
ralf.witteler@ukmuenster.de
Contact Person Name
Ralf Witteler
Contact Person Email
ralf.witteler@ukmuenster.de
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Klinik für Gynäkologie und Geburtshilfe
Principal Investigator Name
Christine Mau
Principal Investigator Email
christine.mau@helios-gesundheit.de
Contact Person Name
Christine Mau
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
NCT/UCC, Gynäkologisches Krebszentrum und Regionales Brustzentrum
Principal Investigator Name
Pauline Wimberger
Principal Investigator Email
pauline.wimberger@ukdd.de
Contact Person Name
Pauline Wimberger
Contact Person Email
pauline.wimberger@ukdd.de

Belgium

Earliest CTIS Part Ii Submission Date
20-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
10
Number Of Sites
3
Number Of Participants
23

Sites

Site Name
UZ Leuven
Department Name
Gynaecological oncology
Principal Investigator Name
Toon Van Gorp
Principal Investigator Email
toon.vangorp@uzleuven.be
Contact Person Name
Toon Van Gorp
Contact Person Email
toon.vangorp@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Medical oncology
Principal Investigator Name
Hannelore Denys
Principal Investigator Email
hannelore.denys@ugent.be
Contact Person Name
Hannelore Denys
Contact Person Email
hannelore.denys@ugent.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Oncology
Principal Investigator Name
Stéphanie Henry
Principal Investigator Email
stephanie.henry@chuuclnamur.uclouvain.be
Contact Person Name
Stéphanie Henry

Italy

Earliest CTIS Part Ii Submission Date
05-02-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
99
Number Of Sites
7
Number Of Participants
70

Sites

Site Name
AUSL Piacenza - Ospedale "Guglielmo Da Saliceto"
Department Name
Oncologia
Principal Investigator Name
Rosa Porzio
Principal Investigator Email
r.porzio@ausl.pc.it
Contact Person Name
Rosa Porzio
Contact Person Email
r.porzio@ausl.pc.it
Site Name
Azienda Usl Toscana nord ovest - Ospedale San Luca
Department Name
Oncologia
Principal Investigator Name
Editta Baldini
Principal Investigator Email
editta.baldini@uslnordovest.toscana.it
Contact Person Name
Editta Baldini
Site Name
Alessandro Manzoni Hospital
Department Name
Oncologia
Principal Investigator Name
Alessandra Crippa
Principal Investigator Email
a.crippa@asst-lecco.it
Contact Person Name
Alessandra Crippa
Contact Person Email
a.crippa@asst-lecco.it
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
Ginecologia e Ostetricia
Principal Investigator Name
Annamaria Ferrero
Principal Investigator Email
annamaria.ferrero@unito.it
Contact Person Name
Annamaria Ferrero
Contact Person Email
annamaria.ferrero@unito.it
Site Name
AUSL di Reggio Emilia IRCCS, Arcispedale Santa Maria Nuova di Reggio Emilia
Department Name
Oncologia
Principal Investigator Name
Alessandra Bologna
Principal Investigator Email
alessandra.bologna@ausl.re.it
Contact Person Name
Alessandra Bologna
Contact Person Email
alessandra.bologna@ausl.re.it
Site Name
Ospedale Infermi di Rimini
Department Name
Oncologia
Principal Investigator Name
Marta Rosati
Principal Investigator Email
marta.rosati@auslromagna.it
Contact Person Name
Marta Rosati
Site Name
Istituto Oncologico Veneto
Department Name
Oncologia 2
Principal Investigator Name
Giulia Tasca
Principal Investigator Email
giulia.tasca@iov.veneto.it
Contact Person Name
Giulia Tasca
Contact Person Email
giulia.tasca@iov.veneto.it

Sponsor

Primary sponsor

Full Name
AGO Research GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Almac Clinical Services Limited
Responsibilities
Study Drug Clinical packaging, Clinical Labelling, Storage, Distribution and QP Certification
Name
Schantl Pharma Service GmbH
Responsibilities
Pharmaceutical services (product role indicated)

Third parties

  • {"country":"Germany","full_name":"University Hospital Cologne AöR","duties_or_roles":"Tumor BRCA testing, Assessment and monitoring of clonal hematopoiesis to identify AML/MDS risk","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR","duties_or_roles":"Pseudonymisation service","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Charite Universitaetsmedizin Berlin KöR","duties_or_roles":"Storage of biosamples after analyses","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Philipps-Universitaet Marburg","duties_or_roles":"Treatment randomisation; other sponsor duties (codes present)","organisation_type":"Educational Institution"}
  • {"country":"Germany","full_name":"Schantl Pharma Service GmbH","duties_or_roles":"Unspecified (product role code present)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Study Drug Clinical packaging, Clinical Labelling, Storage, Distribution and QP Certification","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Medizinische Hochschule Hannover","duties_or_roles":"GWAS analysis","organisation_type":"Educational Institution"}

Investigational products

Investigational Product Name
Zejula 100 mg hard capsules
Active Substance
NIRAPARIB TOSILATE MONOHYDRATE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Authorised (marketingAuthNumber EU/1/17/1235/001 / prodAuthStatus 2)
Dose Levels
max daily dose 300 mg
Maximum Dose
300 mg (maxDailyDoseAmount)
Investigational Product Name
Zejula 100 mg film-coated tablets
Active Substance
NIRAPARIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Authorised (marketingAuthNumber EU/1/17/1235/006 / prodAuthStatus 2)
Dose Levels
max daily dose 300 mg
Maximum Dose
300 mg (maxDailyDoseAmount)
Investigational Product Name
Avastin 25 mg/ml concentrate for solution for infusion.
Active Substance
BEVACIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
intravenous
Authorisation Status
Authorised (prodAuthStatus 2)
Dose Levels
max dose 15 mg/Kg
Maximum Dose
15 mg/Kg (maxDailyDoseAmount)
Investigational Product Name
Paclitaxel-GRY® 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
intravenous
Authorisation Status
Authorised (prodAuthStatus 2)
Dose Levels
max dose 175 mg/m2
Maximum Dose
175 mg/m2 (maxDailyDoseAmount)
Investigational Product Name
Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
intravenous
Authorisation Status
Authorised (prodAuthStatus 2)
Dose Levels
max dose 400 mg/m2
Maximum Dose
400 mg/m2 (maxDailyDoseAmount)
Combination Treatment
Yes

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