Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000, China
NCT Number: NCT04517357
This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.
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Notify Me18 year and older
Female
Interventional
Phase 2
Hangzhou, Zhejiang, 310000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fluzoparib-Apatinib combination
Fluzoparib monotherapy
Time frame: up to 28 days
Time frame: up to 28 days
Time frame: Assessed up to a maximum of 20 months
Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment
Time frame: Assessed up to a maximum of 20 months
Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment
Time frame: from the first drug administration to within 30 days for the last treatment dose
Adverse Events and Serious Adverse Events
Time frame: up to 20 months
Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment
Time frame: up to 20 months
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
Time frame: up to 20 months
Time from documentation of tumor response to disease progression assessed among patients who had an objective response
Time frame: up to 20 months
Time frame: up to 20 months
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Phase 2 Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in the Treatment of Relapsed Ovarian Cancer Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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