Actively Recruiting
Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma
Led by Shandong University · Updated on 2024-01-05
83
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
Sponsors
S
Shandong University
Lead Sponsor
S
Sun Yat-sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 or above
- Histological confirmation of serous endometrial cancer or other types of endometrial cancer
- FIGO stage III-IV
- ESC patients who have received at least 6 cycles of first-line platinum-containing chemotherapy after surgery and achieved complete response, partial response, or stable disease
- ESC patients who have received platinum-containing chemotherapy after the first relapse and achieved complete response, partial response, or stable disease, enrolled in cohort 1 to receive niraparib as maintenance therapy within 12 weeks after last chemotherapy
- ESC patients who have received more than 2 lines of platinum-containing chemotherapy and relapsed, or patients with other types of endometrial cancer who have received more than 2 lines of platinum-containing chemotherapy and have BRCA mutation or are HRD positive, enrolled in cohort 2 to receive niraparib monotherapy
- History of radiotherapy or endocrine therapy is allowed
- Cohort 1 life expectancy over 6 months; cohort 2 life expectancy over 4 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Agreement to provide blood samples for BRCA status and homologous recombination repair mutation testing
- Agreement to provide formalin-fixed paraffin-embedded tumor tissue samples for homologous recombination repair gene detection (optional)
- Laboratory values within specified limits for neutrophils, platelets, hemoglobin, serum creatinine, bilirubin, AST, and ALT
- Negative pregnancy test if of reproductive potential and commitment to effective contraception during the study, or defined as without fertility potential by surgery, age, menopause status, or hormone tests
- Willingness to sign informed consent and follow the study plan
- Recovery from previous chemotherapy toxicities to grade 1 or baseline, except stable sensory neuropathy or hair loss grade 2 or less
You will not qualify if you...
- Allergy to niraparib or chemically similar drugs
- Stage Ia endometrial cancer without myometrium invasion
- Symptomatic, uncontrolled brain or pial metastases; spinal cord compression only if clinically stable for at least 28 days
- Surgery within 3 weeks prior to study start or unrecovered surgical effects
- Palliative radiotherapy involving more than 20% bone marrow within 1 week before enrollment
- Other aggressive cancers within 2 years, except fully treated basal or squamous cell skin cancer
- Current or previous diagnosis of myelodysplastic syndrome or acute myeloid leukemia
- Serious or uncontrolled diseases interfering with drug absorption or study results, including gastrointestinal disorders, active viral infections, seizures, mental disorders, immune deficiencies (except splenectomy)
- Platelet or red blood cell transfusion within 4 weeks before study start
- Pregnant, breastfeeding, or expecting pregnancy during the study
- Previous treatment with any PARP inhibitor
AI-Screening
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Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
Q
Qing Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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