A Phase II Trial to Explore Niraparib and Anlotinib Maintenance Retreatment in Platinum-Sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi (t)
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|ClinicalTrials.gov Identifier: NCT05385068|
Recruitment Status : Not yet recruiting
First Posted : May 23, 2022
Last Update Posted : May 23, 2022
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Ovarian Cancer||Drug: Niraparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single-arm, Phase II Study to Investigate the Efficacy and Safety of Niraparib Combined With Anlotinib Maintenance Retreatment in PSR Ovarian Cancer Patients, Who Have Previously Received PARPi Maintenance Treatment.|
|Estimated Study Start Date :||June 2022|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||September 2024|
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) .
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
Other Name: Anlotinib
- Progression free survival (PFS) [ Time Frame: Up to 1 year ]PFS is assessed as the time from niraparib treatment initiation to the earlier date of assessment of progression, as assessed by RECIST v1.1 criteria based on Investigator assessment, or death by any cause in the absence of progression
- Progression Free Survival (PFS) Rate at 6 months [ Time Frame: 6 months ]PFS rate at 6 months is defined as the proportion of participants who have not progressed or died within 6 months after niraparib treatment initiation. Progression will be assessed by RECIST v1.1 criteria per investigator assessment）
- Time to First Subsequent Therapy (TFST) [ Time Frame: The date of initiation of niraparib treatment in the current study to the start date of the first subsequent anticancer therapy assessed up to 15 months. ]TFST is defined as the date of initiation of niraparib treatment in the current study to the start date of the first subsequent anticancer therapy.
- Overall Survival (OS) [ Time Frame: From the time of enrollment to date of death by any cause assessed up to 36 months. ]OS is defined as the date of initiation of niraparib treatment to the date of death by any cause.
- Frequency and severity of adverse effects as defined by CTCAE version 5.0 [ Time Frame: From the time of enrollment to date of 30 days after the last study drug administration. ]Number of patients with any non-serious adverse event (non-SAE) or any SAE to evaluate the safety and tolerability of niraparib combined with anlotinib.