Patients with advanced hormone refractory prostate carcinoma without docetaxel pretreatment MedDRA version: 6.1 Level: PT Classification code 10036909
Conditions
Interventions
Product Name: sorafenib
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: docetaxel
Current Sponsor code: 2135/2006
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
Male
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: N? of no progressive disease at 6 months;Secondary Objective: ? Objective response rate ? Duration of responses, time to progression and overall survival. ? Toxicity ? Pharmacokinetics and pharmacodynamics of Sorafenib plus docetaxel plus prednisone;Primary end point(s): Number of progressive disease (stable disease, partial and minor responses) after 6 cycles treatment | — |
Countries
Italy
Outcome results
None listed