Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Provision of informed consent
Histological or cytological confirmation of prostate cancer
Evidence of metastatic disease on CT scan, MRI, or bone scan
Surgically or continuously medically castrated with LHRH analogue
Progressive disease after most recent therapy
* Disease progression by CT/MRI
* Bone scan progression: appearance of 1 or more new lesions since last bone scan
* Rising PSA
World health organization (WHO) performance status 0 to 2
Life expectancy of 12 weeks or longer
You may not be if
Use of anti-hormonal therapies (including ketoconazole, aminoglutethimide, finasteride and anti-androgen therapies) within 4 weeks of starting study treatment, except for bicalutamide and nilutamide which are excluded within 6 weeks of starting study treatment. Estramustine or estrogens, if taken, have to be stopped at least 4 weeks before starting treatment.
Definite or suspected personal history or family history of adverse drug reactions, or hypersensitivity to drugs that are endothelin antagonist; history of severe hypersensitivity reactions to drugs formulated with polysorbate 80.
Prior cytotoxic chemotherapy for metastatic prostate cancer
Radiotherapy within 4 weeks before the start of study therapy
Systemic radionuclide therapy (ie strontium chloride Sr89, 186Re-labeled HEDP, or 153Sm-EDTMP pentasodium) within 12 weeks before entering study
Use of potent CYP450 inhibitors (such as itraconazole, ritonavir, indinavir, erythromycin, troleandomycin, clarithromycin, diltiazem, verapamil) within 2 weeks before study entry.
Use of potent CYP450 inducers (such as phenytoin, rifampicin, carbamazepine and phenobarbitone, St. John's Wort) within 2 weeks before study entry.
NOTE: Dexamethasone is a known inducer of CYP2D6 and CYP3A4 but is not considered exclusionary for purposes of this study.
New neurologic symptoms or signs consistent with acute or evolving spinal cord compression confirmed by magnetic resonance imaging (MRI) (except for those previously treated and have stable symptoms).
History of past or current epilepsy, epilepsy syndrome, or other seizure disorder
History of Migraine or chronic headache
Symptomatic central nervous system (CNS) metastases
Absolute Neutrophil Count (ANC) \<1.5 x 109/L (1,5000/mm3)
Platelet count \< 100 x 109/L (100,000/mm3)
Serum bilirubin greater than the upper limit of normal (ULN)
Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 1.5 times the upper limit of normal (ULN)
Creatinine clearance \<50 mL/min
QT interval corrected for heart rate by the Barrett Formula (QTc) \> 470 msec at screening
New York Heart Association (NYHA) class II-IV Heart Disease
Myocardial infarction (heart attack) within past 3 months
CTCAE grade ≥2 Peripheral Neuropathy
Treatment with a non-approved or investigational drug within 30 days before study entry
Evidence of any other significant clinical symptoms, abnormal laboratory findings or recent surgery that patients has not recovered from that make it undesirable for the patient to participate in the study in the opinion of the investigator(s)
Involvement in the planning and conduct of the study
Previous treatment in the present study
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