Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma

Sponsor
Shandong University
Study ID
NCT04716686
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    Patients received oral niraparib 200/300 mg QD and every cycle (28 days) thereafter until disease progression.

Study Details

Endometrial Serous carcinoma (ESC) has similar molecular characteristics to high-grade serous ovarian carcinoma (HGSOC) and basal cell-like breast cancer, such as similar Chromosomal instability, somatic copy number variation profiles and somatic mutations. The clinical treatment of ESC also refers to the treatment model of HGSOC. The PARP inhibitor niraparib used in this study, which was approved by FDA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy on March 27, 2017. The homologous recombination related gene mutations in total endometrial cancer accounted for 22%. Homologous Recombination Repair Defect (HRD) +ARID1A accounted for 48%, and 53% of endometrial cancer cell lines were sensitive to PARP inhibitors. The incidence of HRD in endometrial cancer with high copy number (the pathological type is mainly ESC) is 50%, suggesting potential clinical applications of PARP inhibitors for the treatment of ESC.

Key Dates

Start date
Jun 1, 2021
Status verified
Jan 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
83 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib as maintenance therapy for Endometrial Serous Carcinoma
    For patients with baseline weight ≥ 77 kg and baseline platelets ≥ 150000/uL, a starting dose of 300 mg QD will be given; other patients will be given a starting dose of 200 mg QD. One treatment cycle is 28 days; follow-up and evaluation will be conducted every 2 cycles until the disease progression or patients cannot tolerate.
  • Experimental: Niraparib as recurrent therapy for Endometrial Carcinoma
    For patients with baseline weight ≥ 77 kg and baseline platelets ≥ 150000/uL, a starting dose of 300 mg QD will be given; other patients will be given a starting dose of 200 mg QD. One treatment cycle is 28 days; follow-up and evaluation will be conducted every 2 cycles until the disease progression or patients cannot tolerate.

Primary Outcome Measure

PFS%（1 year） [ Time Frame: assessed up to 12 months ]

Central Contacts

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