Clinical Trials Directory

Trials / Unknown

UnknownNCT05327621

Pamiparib in mCRPC With HRD or BRCA1/2 Mutation

A Single Arm, Open-label, Phase II Study to Assess the Efficacy of Pamiparib in Metastatic Castration-Resistant Prostate Cancer Patients With Homologous Recombination Deficiency (HRD) or BRCA1/2 Mutation

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Sun Yat-sen University · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to assess the efficacy of a PARP inhibitor, Pamiparib, in metastatic castration-resistant prostate cancer patients with homologous recombination deficiency or BRCA 1 or 2 somatic/germline mutation.

Detailed description

This is a single arm, open-label, single center, phase II trial, assessing the efficacy of a PARP inhibitor, Pamiparib, in 50 progressing metastatic castration-resistant prostate cancer patients with at least one line of androgen deprivation therapy or chemotherapy at the metastatic setting, and homologous recombination deficiency or BRCA 1 or 2 somatic or germline mutation.

Conditions

Interventions

TypeNameDescription
DRUGPamiparib40 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops.

Timeline

Start date
2022-05-01
Primary completion
2025-03-20
Completion
2025-03-20
First posted
2022-04-14
Last updated
2022-04-14

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05327621. Inclusion in this directory is not an endorsement.