An observational study in Ovarian Cancer, sponsored by Qianfoshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Qianfoshan Hospital · Observational
This is a non-intervention, prospective, one-arm, observational real-world clinical trial. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study was to establish a population pharmacokinetic model of Pamiparib and to explore the correlation between its pharmacokinetic parameters and adverse reactions.
In recent years, the advent of poly(ADP-ribose) polymerase(PARP) inhibitors is one of the important breakthroughs in the field of tumor-targeted therapy, and its therapeutic effect on ovarian cancer is quite significant Pamiparib is a potent, selective, oral PARP 1/2 inhibitor. In preclinical models, pamiparib demonstrated PARP-DNA complex trapping, brain penetration, antitumor activity, and inhibition of PARylation.
Therefore, at least 50 patients using pamiparib will be included. Before and after treatment, the laboratory examination data ，blood concentration ，combined medication and adverse events of the patients will be collected. The population pharmacokinetic model of pamiparib was established to evaluate the correlation between pharmacokinetic parameters and adverse reactions.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Qianfoshan Hospital is the lead sponsor of 140 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients using pamipalil must sign a written informed consent before collecting blood samples.
Exclusion Criteria:
Blood drug concentration
After treating with Pamipali, blood samples were collected at different time periods
Time frame: 6 months
Correlation between blood drug concentration and adverse events
Try to find the relationship between pharmacokinetic parameters and adverse events
Time frame: 6 months
Plan to share: Yes
Supporting information: Icf
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Qianfoshan Hospital