PHASE II STUDY OF BAY 43-9006, DOCETAXEL AND PREDNISONE IN METASTATIC PROSTATE CANCER - ND

• Conditions: Patients with advanced hormone refractory prostate carcinoma without docetaxel pretreatment; MedDRA version: 6.1Level: PTClassification code 10036909

• Registration Number: EUCTR2007-001318-18-IT
• Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

a.Histologically confirmed prostate cancer

b.Hormone refractory disease

c.Progressive disease after discontinuation of treatment with an antiandrogen

d.ECOG PS score < 2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a.Previous treatment with docetaxel based-regimen

b.Cardiovascular: clinically relevant abnormalities, myocardical infarctions or other severe coronary artery diseases within the prior six months, cardiac arrhythmia requiring medication, or uncontrolled hypertension. Cardiac failure or non compensated active heart disease (> class II of NYHA classification)

c.Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma in situ

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified