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

Recruiting Phase 2 Interventional Study
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Clear Cell Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
640 (estimated)
Sponsor
North Eastern German Society of Gynaecological Oncology · Other
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About This Trial
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 v…
Trial Locations
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Eligibility Criteria
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…
Contacts

Jessica Nguyen

4930403686539

jessica.nguyen@noggo.de

CONTACT

Jasmin Yamamoto

4930403686532

jasmin.yamamoto@noggo.de

CONTACT