Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
NCT Number: NCT03863860
To evaluate the efficacy, safety tolerability of maintenance therapy with Fluzoparib(A PARP inhibitor) versus placebo in Chinese patients with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy
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Notify Me18 year and older
Female
Interventional
Phase 3
Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fluzoparib capsules
Other names: SHR-3162
Placebo capsule
Other names: Placebo
Time frame: up to 2 years
Defined as progression free survival per RECIST 1.1 criteria
Time frame: up to 2 years
Defined as progression free survival per RECIST 1.1 criteria
Time frame: up to 2 years
PFS is Progression-Free-Survival per RECIST 1.1 criteria
Time frame: up to 2 years
TTP is Time to Progression
Time frame: up to 2 years
CFI is the time from last platinum dose until initiation of next anticancer therapy (excluding maintenance therapy if used following the penultimate regimen)
Time frame: up to 3 years
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Time frame: At baseline,at the time point of every 12 weeks, up to 2 years
Objective Response Rate complete or partial response per RECIST 1.1 criteria
Time frame: from the first drug administration to within 30 days for the last treatment dose
assess the safety and tolerability of Fluzoparib maintenance monotherapy in platinum sensitive relapsed ovarian cancer patients by record the number of Participants with of AEs and SAEs, and the proportion of patients with AEs and SAEs, etc.
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With Fluzoparib Capsules Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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