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

Sponsor
North Eastern German Society of Gynaecological Oncology
Study ID
NCT05460000
Phase
PHASE2
Status
Recruiting
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Conditions

  • Clear Cell Carcinoma
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 3 cycles chemotherapy instead of 6 cycles chemotherapy — DRUG
    We hypothesise that recurrence free survival in patients receiving 3 cycles of chemotherapy followed by maintenance with niraparib is not inferior to 6 cycles of chemotherapy followed by niraparib in advanced HRDpositive high-grade ovarian cancer patients with no residual tumor mass following primary tumor debulking.
  • 6 cycles chemotherapy — DRUG
    Standard chemotherapy as comparator

Study Details

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.

Key Dates

First listed
Jul 15, 2022
Start date
Oct 11, 2024
Status verified
Feb 2026
Primary completion
Oct 1, 2032
Completion
Oct 1, 2032

Study Design

Enrollment
640 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

RFS [ Time Frame: 8 years ]

Central Contacts

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