Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genzyme, a Sanofi Company
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Males presented with a confirmed histological diagnosis of adenocarcinoma of the prostate with evidence of metastases (including bone, lymph nodes, or other site) radiologically or histologically documented and despite a serum testosterone ≤1.73 nmol/L (50 ng/dL) proving castration, evidence of biochemical progression of prostate cancer, documented by a rise in PSA .
You may not be if
Radiotherapy or surgery or antiandrogens (except LHRH analogue) or bilateral orchiectomy within the 30 days preceding Visit 1. Incompletely healed surgical incision.
Concomitant anticancer therapy other than surgical castration or continuous medical castration.
Biology restriction.
Clinical significant cardiovascular event or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
History of arrhythmia which is symptomatic or requires treatment (CTCAE grade 3), symptomatic despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled on medication are permitted.
Hypertension not controlled by medical therapy
ECG /QTc prolongation
Presence of left bundle branch block (LBBB).
Clareo Health | Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer
