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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Blood drug concentration | After treating with Pamipali, blood samples were collected at different time periods | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between blood drug concentration and adverse events | Try to find the relationship between pharmacokinetic parameters and adverse events | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients using pamipalil must sign a written informed consent before collecting blood samples.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huang Xin | Contact | 13791120711 | 13791120711@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Huang Xin | Qianfoshan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xin Huang | Recruiting | Jinan | Shandong | 250014 | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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Detect the drug concentration in the patient's blood
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |