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Trial Title:
PPK Study Based on Quantitative Pharmacology in Patients With Pamipril
NCT ID:
NCT05848648
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Conditions: Keywords:
Ovarian Cancer
Pamiparib
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients using pamipalil must sign a written informed consent before collecting blood
samples.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xin Huang
Address:
City:
Jinan
Zip:
250014
Country:
China
Status:
Recruiting
Contact:
Last name:
xin huang
Start date:
May 1, 2023
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Qianfoshan Hospital
Agency class:
Other
Source:
Qianfoshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05848648
