A Phase II Trial to Explore Niraparib and Anlotinib Maintenance Retreatment in Platinum-Sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05385068
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    Niraparib 200 or 300mg\* QD PO continually; \*The starting dose of niraparib was individualized based on patients' bodyweight and baseline platelet count; 200 mg QD for Patients with baseline body weight \<77 kg or platelets count \<150,000/μL;300 mg QD for Patients with baseline body weight ≥77 kg and platelets count ≥150,000/μL. For patients who had experienced grade 4 adverse events from previous use of PARPi, niraparib staring dose was 200 mg QD. Anlotinib 10mg QD PO from Day 1 to 14 of every 21-day cycle

Study Details

This study will be an open-label, single-arm, prospective, exploratory phase II trial to investigate the efficacy and safety of niraparib maintenance retreatment in platinum- sensitive recurrent (PSR) epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer).

Key Dates

Start date
Jun 30, 2022
Status verified
May 2022
Primary completion
Mar 31, 2024
Completion
Sep 30, 2024

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib combined with Anlotinib
    Participants received Niraparib 200mg or 300mg QD PO continually and Anlotinib 10mg QD PO on Days 1-14 (21 days/cycle) .

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: Up to 1 year ]

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