PPK Study Based on Quantitative Pharmacology in Patients With Pamipril

Qianfoshan Hospital

Status: Enrolling

Conditions: Ovarian Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05848648

QFS-HX-2023-PMPL-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.