A phase II study in mCRPC on the pharmacodynamic effects of budesonide on cabazitaxel (Jevtana®): A randomised, open-label multicenter study: CABARESC
Phase 2
Completed
- Conditions
- metastatic castrate resistant prostate cancer10038597
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 270
Inclusion Criteria
• Metastatic castrate resistant prostate cancer patients with documented disease progression (Resist criteria (measurable disease) or PSA (non-measurable disease))
• Previous treatment with a docetaxel-containing regimen
• Age 18 years and above
• WHO performance status 0-1
• Castration, either surgically or by continued LHRH agonist therapy.
Exclusion Criteria
• CYP3A inducers or inhibitors
• Systemic or local bacterial, viral, fungal or yeast infection
• Portal hypertension (grade 1-4 CTC-NCI criteria)
• Ulcerative colitis, Crohn*s disease or celiac disease
• Simultaneous yellow fever vaccine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method