The purpose of this study is to assess the efficacy of a PARP inhibitor, Pamiparib, in metastatic castration-resistant prostate cancer patients with homologous recombination deficiency or BRCA 1 or 2 somatic/germline mutation.
This is a single arm, open-label, single center, phase II trial, assessing the efficacy of a PARP inhibitor, Pamiparib, in 50 progressing metastatic castration-resistant prostate cancer patients with at least one line of androgen deprivation therapy or chemotherapy at the metastatic setting, and homologous recombination deficiency or BRCA 1 or 2 somatic or germline mutation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
40 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGRadiologic Progression-free Survival (rPFS)
Radiologic progression-free survival will be assessed from the time of the first dose to radiologic disease progression or death from any cause, whichever comes first.
Time frame: 3 years
Objective Response Rate (ORR)
Proportion of patients in complete remission (CR) plus partial remission (PR)
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Duration of Response (DOR)
Time from the start of the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause.
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Time to Response (TTR)
Time from initiation of treatment to first assessment of tumor as CR or PR.
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Clinical Benefit Rate
according to RECIST, is either complete response (CR), partial response (PR) or stable disease (SD) lasting for at least 16 weeks
Time frame: 3 years
Prostate Specific Antigen (PSA) Response Rate
Proportion of patients with a 50% decrease in PSA from baseline
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Time to PSA Progression
Time from initiation of treatment to two consecutive 50% PSA increases from baseline level
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Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Overall Survival (OS)
Time between the start of treatment and death from any cause
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Adverse events
Adverse events are graded according to the CTCAE V4.03
Time frame: 3 years