PPK Study Based on Quantitative Pharmacology in Patients With Pamipril

Ovarian Cancer Clinical Trial

Official title:

PPK Study Based on Quantitative Pharmacology in Patients With Pamipril

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848648
• Other study ID #: QFS-HX-2023-PMPL-001
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: Qianfoshan Hospital
• Contact: Huang Xin
• Phone: 13791120711
• Email: 13791120711[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
China	Xin Huang	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood drug concentration	After treating with Pamipali, blood samples were collected at different time periods	6 months
Secondary	Correlation between blood drug concentration and adverse events	Try to find the relationship between pharmacokinetic parameters and adverse events	6 months