NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Prostate Cancer
Date of first enrollment	02/09/2011
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : AZD3514 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Patients will be given AZD3514 tablets or capsules administered orally as a single dose, and then multiple once-daily dosing following a 7 day washout

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Male
Include criteria	- Histologically or Cytologically proven diagnosis of prostate cancer for which no standard therapy is currently considered appropriate - Documented evidence of metastatic prostate cancer - Serum testosterone concentration 50ng/dL or less - World Health Organisation (WHO) performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
Exclude criteria	- History of hypersensitivity to active or inactive excipients of AZD3514 or drugs with a similar chemical structure or class to AZD3514 - Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD3514 - Inadequate bone marrow reserve or organ function - Concurrent or recent treatment with certain medications or medical procedures - Any medically important factors identified from electrocardiogram (ECG) measurements