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 (N-Plus)

Status: Recruiting
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent and obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.

• Female patient, age ≥ 18 years.

• FIGO Stage III-IV high-grade ovarian cancer (all histological types, except mucinous histology)

• Complete primary debulked patients (without any macroscopic residuals), confirmed by CT-Scan postoperatively.

• 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.

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

• Patients must be able to take oral medications.

• 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.

• Patients must have normal organ and bone marrow function:

∙ Hemoglobin ≥ 10.0 g/dL independent of transfusion ≤ 14 days prior to screening hemoglobin assessment

‣ Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

‣ Platelet count ≥ 100 x 109/L

‣ Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); \< 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome

‣ Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2,5 x ULN

‣ Serum creatinine ≤ 1.5 x institutional ULN and creatinine clearance \> 30 mL/min.

⁃ 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:

• Considered to be permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy; or

• 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.

Locations
Other Locations
Austria
Universitätsklinik Innsbruck
RECRUITING
Innsbruck
Belgium
Cliniques Universitaires St. Luc
NOT_YET_RECRUITING
Brussels
Jessa ziekenhuis
NOT_YET_RECRUITING
Hasselt
UZ Leuven
NOT_YET_RECRUITING
Leuven
Germany
Universitätsklinikum Aachen
RECRUITING
Aachen
Klinikum Mittelbaden Baden-Baden Bühl
NOT_YET_RECRUITING
Baden-baden
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
RECRUITING
Berlin
DRK-Kliniken Berlin-Köpenick
RECRUITING
Berlin
Uniklinikum Bonn
NOT_YET_RECRUITING
Bonn
ZAHO Bonn Onkologische Praxis
RECRUITING
Bonn
Klinikum Lippe
NOT_YET_RECRUITING
Detmold
Universitätsklinikum Carl Gustav Carus
RECRUITING
Dresden
Florence-Nightingale-Krankenhaus Düsseldorf-Kaiserswerth
NOT_YET_RECRUITING
Düsseldorf
Universitätsklinikum Freiburg
NOT_YET_RECRUITING
Freiburg Im Breisgau
Universitätsklinik Göttingen
NOT_YET_RECRUITING
Göttingen
Universitätsklinikum Hamburg-Eppendorf
NOT_YET_RECRUITING
Hamburg
SLK-Kliniken Heilbronn
NOT_YET_RECRUITING
Heilbronn
Universitätsklinikum Schleswig-Holstein Campus Kiel
NOT_YET_RECRUITING
Kiel
Universitätsklinikum Leipzig
NOT_YET_RECRUITING
Leipzig
Universitätsklinik der Johannes-Gutenberg Universität Mainz
RECRUITING
Mainz
Diakonie Klinikum Schwäbisch Hall
NOT_YET_RECRUITING
Schwäbisch Hall
Christliches Klinikum Unna Mitte
RECRUITING
Unna
Helios Dr. Horst Schmidt Kliniken Wiesbaden
RECRUITING
Wiesbaden
Italy
Policlinico St. Orsola Malpighi
NOT_YET_RECRUITING
Bologna
ASST Spedali Civili di Brescia
NOT_YET_RECRUITING
Brescia
ASST Lecco - Ospedale A. Manzoni
NOT_YET_RECRUITING
Lecco
IRCCS Istituto nazionale dei Tumori
NOT_YET_RECRUITING
Milan
AOU Cagliari
NOT_YET_RECRUITING
Monserrato
Istituto Oncologico Veneto (IOV)
NOT_YET_RECRUITING
Padua
Azienda Ospedaliera Universitaria Pisana
NOT_YET_RECRUITING
Pisa
Azienda USL IRCCS Di Reggio Emilia
NOT_YET_RECRUITING
Reggio Emilia
AO Ordine Mauriziano
NOT_YET_RECRUITING
Torino
AOU Città della Salute e della Scienza di Torino - Ospedale Sant'Anna
NOT_YET_RECRUITING
Torino
Spain
Hospital General Universitario Dr. Balmis
NOT_YET_RECRUITING
Alicante
Hospital Virgen de las Nieves
NOT_YET_RECRUITING
Granada
Hospital Universitario Lucus Augusti
NOT_YET_RECRUITING
Lugo
CIOCC Clara Campal
NOT_YET_RECRUITING
Madrid
H. Althaia Manresa
NOT_YET_RECRUITING
Manresa
H.U. Virgen de la Macarena
NOT_YET_RECRUITING
Seville
Hospital Universitario Virgen del Rocío
NOT_YET_RECRUITING
Seville
Hospital Universitario Sant Joan de Reus
NOT_YET_RECRUITING
Tarragona
Hospital General Universitario de Valencia
NOT_YET_RECRUITING
Valencia
Hospital La Fe
NOT_YET_RECRUITING
Valencia
Contact Information
Primary
Jessica Nguyen
jessica.nguyen@noggo.de
4930403686539
Backup
Jasmin Yamamoto
jasmin.yamamoto@noggo.de
4930403686532
Time Frame
Start Date: 2024-10-11
Estimated Completion Date: 2032-10-01
Participants
Target number of participants: 640
Treatments
Experimental: Arm A (3 cycles of chemotherapy + maintenance therapy with niraparib)
3 cycles carboplatin + paclitaxel maintenance therapy with niraparib (starting dose 200 mg QD or 300 mg QD); maintenance continues until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria.
Active_comparator: Arm B (6 cycles of chemotherapy + maintenance therapy with niraparib)
6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib (starting dose 200 mg QD or 300 mg QD); maintenance continues until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria.
Related Therapeutic Areas
Sponsors
Leads: North Eastern German Society of Gynaecological Oncology
Collaborators: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

This content was sourced from clinicaltrials.gov

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