Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorShandong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18 or above
Histological confirmation of serous endometrial cancer or other types of endometrial cancer
FIGO stage III-IV
ESC Patients have received at least 6 cycles of first-line platinum containing chemotherapy after surgery and achieved CR, PR or SD; ESC patients have received platinum containing chemotherapy after the first relapse and achieved CR, PR or SD; these two types of patients are enrolled in cohort 1 and receive niraparib alone as maintenance therapy within 12 weeks after the last chemotherapy treatment.
Disqualifiers
Allergic to active or inactive ingredients of ZL-2306 (nirapali) or drugs with similar chemical structure to ZL-2306 (nirapali)
Stage Ia(on invasion to myometrium)
Symptomatic, uncontrollable brain metastases or pial metastases(No imaging scan is required); patients with spinal cord compression can still be considered for enrollment if they have received targeted therapy and have evidence of clinically SD for at least 28 days (patients with controlled central nervous system metastasis must have received radiotherapy or chemotherapy at least 1 month before and with no new symptoms related to central nervous system lesions or symptoms suggesting disease progression)
Received surgery within 3 weeks before the start of the study, or any surgical effects that have not recovered.
Trial design
Design model
Parallel
Treatments tested in this trial
Niraparib
DrugPatients received oral niraparib 200/300 mg QD and every cycle (28 days) thereafter until disease progression.
Treatment groups
83 Participants
are divided into 2 treatment groupsGroup A: Niraparib as maintenance therapy for Endometrial Serous CarcinomaExperimental treatment 1 intervention
Group B: Niraparib as recurrent therapy for Endometrial CarcinomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PFS%（1 year）
for maintenance therapy arm
Time frame
assessed up to 12 months2
Objective Response Rate (ORR)
for maintenance therapy arm
Time frame
assessed up to 30months]Secondary outcomes
1
PFS%（2 year）
for maintenance therapy am
Time frame
assessed up to 24 months2
Overall Survival (OS)
for maintenance therapy am
Time frame
assessed up to 30 months3
Median PFS
for recurrent therapy am
Time frame
assessed up to 30 months4
TEAEs
for maintain and recurrent therapy arms
Time frame
assessed up to 30 monthsOther outcomes
1
PFS/ORR of Participants with BRCA+ or HRD+
for maintain / recurrent therapy arms
Time frame
assessed up to 30 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shandong University
Lead sponsor
Sun Yat-sen University
Collaborator
Tongji Hospital
Collaborator
Women's Hospital School Of Medicine Zhejiang University
Collaborator
Zai Lab (Shanghai) Co., Ltd.
Collaborator
Source ClinicalTrials.gov