Status and phase
Conditions
Treatments
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
≥18 years old, male
Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma without neuroendocrine differentiation of the prostate. Mixed histology is accepted, except for small cell carcinoma.
Have a deleterious mutation in BRCA1/2 , or HRD score ≥ 9.
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
BPI<4
Metastatic Castration-resistant Prostate Cancer (mCRPC): Presence of measurable target lesion according to RECIST criteria v1.1
Male subject has been surgically or medically sterilized and has serum testosterone level ≤1.73nmol/L.
Unsterilized male subject uses an acceptable method of contraception (defined as a barrier method with spermicide) to prevent pregnancy during the duration of the study and for 6 months after the last dose of Pamiparib.
Experienced disease progression after having received at least 1 prior next-generation androgen receptor-targeted therapies, for metastatic castration-resistant disease.
Capable of swallowing the whole capsule.
Subjects must have normal organ and bone marrow function at baseline, as defined below:
Hemoglobin ≥ 9.0 g/dL at least 28 days after transfusion . Absolute neutrophil count ≥ 1.5 × 10^9/L. Platelet count ≥ 100 × 10^9/L. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN) specified. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase/alanine aminotransferase (ALT) serum glutamic pyruvic transaminase) ≤ 3 × the specified ULN, unless liver metastases are present, in which case it must be ≤ 5 × ULN.
Agree to sign informed consent form
Agree not to participate in other interventional trials during this trial.
Exclusion criteria
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
Primary purpose
Allocation
Interventional model
Masking
50 participants in 1 patient group
Loading...
Central trial contact
Yonghong Li, M.D.; Fangjian Zhou, M.D.
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal