Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
pharmaand GmbH
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form prior to any study-specific evaluation
Be ≥18 yrs of age at the time the informed consent form is signed
Be either AR-directed therapy-naive or have received 1-2 lines of AR-directed therapy in the castration-resistant setting.
Adequate organ function
ECOG 0 or 1
Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic
Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
Have disease progression after initiation of most recent therapy
You may not be if
Active second malignancy, with the exception of curatively treated non melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
Have received greater than 2 previous lines of chemotherapy for mCRPC
Prior treatment with any PARP inhibitor
Symptomatic and/or untreated central nervous system metastases
Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of study drug
Spinal cord compression, symptomatic and/or untreated central nervous system (CNS) metastases or leptomeningeal disease. Patients with asymptomatic previously treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks
Any clinically significant cardiovascular disease
Taking any concomitant medications or herbs that could interfere or interact with the study drug
