PPK Study Based on Quantitative Pharmacology in Patients With Pamipril

Recruiting

• Conditions: Ovarian Cancer

• Registration Number: NCT05848648
• Lead Sponsor: Qianfoshan Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-28
• Study Start: 2023-05-01
• Study First Posted: 2023-05-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-06
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood drug concentration	6 months	After treating with Pamipali, blood samples were collected at different time periods

Secondary Outcome Measures

Name	Time	Method
Correlation between blood drug concentration and adverse events	6 months	Try to find the relationship between pharmacokinetic parameters and adverse events

Trial Locations

Locations (1)

Xin Huang; 🇨🇳 Jinan, Shandong, China