The PamiAP will be a Phase II, single-arm, open label study to explore the efficacy and safety of Pamiparib treatment in patients with Epithelial Ovarian Cancer(EOC) who have had exposure to prior a PARP (poly(ADP-ribose)-polymerase) inhibitor
The landscape for treatment of Epithelial Ovarian Cancer(EOC) is rapidly changing. With the release of data from numerous studies exploring the role of PARP (poly(ADP-ribose)-polymerase) inhibitor as maintenance and treatment, approval has expanded significantly in recent years. However, with the widespread exposure of PARP inhibitor in the patients, whether another PARP inhibitor can be reused in patients with PARP inhibitor resistance or disease progression. We have no data regarding the efficacy or safety of a PARP inhibitor retreatment in patients who have had exposure to prior a PARP inhibitor. The objective of this study was to evaluate the efficacy and safety of Pamiparib in patients with EOC who had previously been treated with PARP inhibitor, and to explore the characteristics of patients who responded to PARP inhibitor again.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Pamiparib, 60mg PO BID
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
CBR at 4 months
Clinical Benefit Rate (CBR) was defined as percentage of participants with confirmed best overall response of complete response (CR), partial response (PR), stable disease (SD) sustained for at least 4 months was assessed by investigators according to RECIST v1.1
Time frame: Up to approximately 18 months
PFS
Progression-free Survival(PFS), the time from the first dosing of the study drug until the first objective recording of disease progression or death from any cause, whichever occurred first
Time frame: Up to approximately 18 months
ORR
Overall Response Rate(ORR), ORR of Pamiparib in patients with EOC were assessed by investigators according to RECIST v 1.1
Time frame: Up to approximately 18 months
DOR
Duration of Response(DOR), refers to the time from the beginning of the first assessment of a tumor as CR or PR to the first assessment of PD or death from any cause were assessed by investigators according to RECIST v 1.1
Time frame: Up to approximately 18 months
AE
Adverse Event(AE), an AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.
Time frame: Up to approximately 21 months
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