Observational study on the effects of Pamiparib in ovarian cancer patients
PPK Study Based on Quantitative Pharmacology in Patients With Pamipril
This study looks at how well Pamiparib works and its side effects in women with ovarian cancer who are receiving this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05848648 on ClinicalTrials.gov |
What this trial studies
This observational study aims to recruit at least 50 patients with ovarian cancer who are being treated with Pamiparib, a selective PARP inhibitor. Researchers will collect data on laboratory examinations, blood concentrations, and adverse events before and after treatment. The goal is to establish a population pharmacokinetic model for Pamiparib and to explore the relationship between its pharmacokinetic parameters and any adverse reactions experienced by patients. This study will provide insights into the drug's effectiveness and safety in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who are currently receiving treatment with Pamiparib.
Not a fit: Patients with a life expectancy of less than the treatment cycle or those receiving other systemic trial drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of Pamiparib's pharmacokinetics and improve treatment outcomes for ovarian cancer patients.
How similar studies have performed: While the use of PARP inhibitors has shown promise in treating ovarian cancer, this specific observational approach to pharmacokinetics is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The age of the patient is ≥ 18 years old and less than 80 years old. 2. Receive treatment with pamipalil. 3. The patient signed a written informed consent form. Exclusion Criteria: 1. The expected survival time may be less than the treatment cycle. 2. Is being treated with other systemic trial drugs. 3. There are other factors that the researchers think are not suitable for joining the group.
Where this trial is running
Jinan, Shandong
- Xin Huang — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Huang Xin
- Email: 13791120711@126.com
- Phone: 13791120711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.