Niraparib vs Niraparib in Combination With Bevacizumab in Patients With Carboplatinum-taxane Based Chemotherapy in Advanced Ovarian Cancer (A Multicentre Randomised Phase III Trial)

Who is this study for? Patients with Ovarian Cancer
What treatments are being studied? Carboplatin+Paclitaxel+Niraparib
Status: Recruiting
Location: See all (65) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is an international, multicenter, randomized, open, Phase III trial to evaluate the efficacy and safety of carboplatin/paclitaxel/bevacizumab followed by bevacizumab and niraparib compared to carboplatin/paclitaxel followed by niraparib in patients with newly diagnosed advanced ovarian cancer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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 stage IIIA2 without nodal involvement) according to recent FIGO classification (= FIGO stage IIIB - IV according to FIGO 2009 classification).

• All patients must have had either upfront primary debulking surgery OR plan to undergo chemotherapy with interval debulking surgery.

• 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.

• Patients must be able to commence systemic therapy within 8 weeks of cytoreductive surgery.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

• Estimated life expectancy \> 3 months.

• 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)

• Adequate coagulation parameters (within 28 days prior to day 1, cycle 1 and within 7 days prior to day 1, cycle 2)

‣ Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤ 1.5 and an Activated ProThrombin Time (aPTT) ≤ 1.5 x institutional upper limit of normal (ULN).

⁃ The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to institution medical standard) and the patient has been on a stable dose of anticoagulants for at least one week at the time of randomization.

⁃ 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 (see Appendix 2).

⁃ 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.

⁃ Negative 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.

⁃ 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.

⁃ 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.

Locations
Other Locations
Germany
Klinikum St. Marien Amberg
RECRUITING
Amberg
Klinikum Augsburg
RECRUITING
Augsburg
Hochtaunus-Kliniken
RECRUITING
Bad Homburg
Helios Klinikum Berlin-Buch
RECRUITING
Berlin
Onkologische Schwerpunktpraxis Bielefeld
RECRUITING
Bielefeld
Städt. Klinikum Brandenburg
RECRUITING
Brandenburg
Klinikum Bremen Mitte
RECRUITING
Bremen
Klinikum Chemnitz
RECRUITING
Chemnitz
St. Elisabeth-Krankenhaus Köln-Hohenlind
RECRUITING
Cologne
Klinikum Dortmund
RECRUITING
Dortmund
Universitätsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Florence-Nightingale-Krankenhaus Düsseldorf
NOT_YET_RECRUITING
Düsseldorf
Universitätsfrauenklinik Düsseldorf
RECRUITING
Düsseldorf
KEM Essen | Evang. Kliniken Essen-Mitte gGmbH
RECRUITING
Essen
Universitätsklinikum Essen
RECRUITING
Essen
Klinikum Esslingen GmbH
RECRUITING
Esslingen Am Neckar
Universitätsklinikum Frankfurt
RECRUITING
Frankfurt
Klinikum Frankfurt Höchst
RECRUITING
Frankfurt Am Main
Universitätsklinikum Gießen
RECRUITING
Giessen
Klinikum Gütersloh
RECRUITING
Gütersloh
Universitätsklinikum Halle
RECRUITING
Halle
Albertinen Krankenhaus
RECRUITING
Hamburg
Mammazentrum HH am Krankenhaus Jerusalem
RECRUITING
Hamburg
Universitätsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
Gynäkologisch-Onkologische Praxis am Pelikanplatz
RECRUITING
Hanover
Universitätsklnikum Heidelberg
RECRUITING
Heidelberg
Klinikum am Gesundbrunnen / SLK-Kliniken Heilbronn GmbH
RECRUITING
Heilbronn
Gyn.-onkolog. Gemeinschaftspraxis Hildesheim
RECRUITING
Hildesheim
Universtitätsklinikum Jena
RECRUITING
Jena
Städtisches Klinikum Karlsruhe
RECRUITING
Karlsruhe
ViDia Christliche Kliniken Karlsruhe
RECRUITING
Karlsruhe
Klinikum Kassel
RECRUITING
Kassel
Klinikverbund Kempten-Oberallgäu gGmbH
NOT_YET_RECRUITING
Kempten
Klinikum Konstanz
NOT_YET_RECRUITING
Konstanz
Zentrum für ambulante gynäkologische Onkologie am HELIOS Klinikum Krefeld
RECRUITING
Krefeld
Universitätsklinikum Leipzig
RECRUITING
Leipzig
St. Vincenz Krankenhaus
RECRUITING
Limburg
UKSH Campus Lübeck
RECRUITING
Lübeck
Klinikum Ludwigsburg
RECRUITING
Ludwigsburg
Universitätsmedizin Mainz
RECRUITING
Mainz
Universitätsklinikum Mannheim GmbH
RECRUITING
Mannheim
UKGM Gießen/Marburg Standort Marburg
RECRUITING
Marburg
Mühlenkreiskliniken, Johannes Wesling Klinikum Minden
RECRUITING
Minden
LMU Klinikum München-Großhadern
RECRUITING
München
Rotkreuzklinikum München
RECRUITING
München
Universitätsklinikum Münster
RECRUITING
Münster
Klinikum Neumarkt
RECRUITING
Neumarkt
MVZ Nordhausen
RECRUITING
Nordhausen
Ortenau Klinikum Offenburg-Kehl
RECRUITING
Offenburg
St. Vincenz Krankenhaus GmbH
RECRUITING
Paderborn
Studienzentrum Onkologie Ravensburg
RECRUITING
Ravensburg
Krankenhaus Barmherzige Brüder
RECRUITING
Regensburg
Klinikum am Steinenberg
RECRUITING
Reutlingen
RoMed Klinikum Rosenheim
RECRUITING
Rosenheim
Klinikum Südstadt Rostock
RECRUITING
Rostock
Thüringen-Kliniken Georgius Agricola
RECRUITING
Saalfeld
Leopoldina Krankenhaus Schweinfurt
RECRUITING
Schweinfurt
g.SUND
RECRUITING
Stralsund
Klinikum Stuttgart
RECRUITING
Stuttgart
Klinikum Traunstein
RECRUITING
Traunstein
Klinikum Mutterhaus
RECRUITING
Trier
Universitätsklinikum Tübingen
RECRUITING
Tübingen
Universitätsklinik Ulm
RECRUITING
Ulm
St. Josefs-Hospital
RECRUITING
Wiesbaden
Klinikum Worms
RECRUITING
Worms
Contact Information
Primary
Sandra Polleis
spolleis@ago-ovar.de
+49 611 880467
Time Frame
Start Date: 2022-09-13
Estimated Completion Date: 2031-12
Participants
Target number of participants: 970
Treatments
Active_comparator: Arm 1
Chemotherapy followed by maintenance with niraparib
Active_comparator: Arm 2
Chemotherapy in combination with bevacizumab followed by maintenance with bevacizumab and niraparib
Related Therapeutic Areas
Sponsors
Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT)
Leads: AGO Study Group

This content was sourced from clinicaltrials.gov

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