PPK Study Based on Quantitative Pharmacology in Patients With Pamipril

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05848648

Enrollment

Registered

2023-05-08

Start date

2023-05-01

Completion date

2026-06-01

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer, Pamiparib

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Blood drug concentration	6 months	After treating with Pamipali, blood samples were collected at different time periods

Secondary

Measure	Time frame	Description
Correlation between blood drug concentration and adverse events	6 months	Try to find the relationship between pharmacokinetic parameters and adverse events

Countries

China

Contacts

Primary ContactHuang Xin

13791120711@126.com13791120711

Outcome results