Studying the influence of budesonide on the exposure of cabazitaxel (Jevtana®) in patients with prostate cancer.
Completed
- Conditions
- prostate cancercabazitaxelbudesonide
- Registration Number
- NL-OMON21762
- Lead Sponsor
- Erasmus Medical Center, Daniel den Hoed Cancer Center
- Brief Summary
ieuweboer et al. Effects of budesonide on cabazitaxel pharmacokinetics and cabazitaxel-induced diarrhea: A randomized open-label multicenter phase II study. Clin Cancer Res. 2016 Oct 4 [Epub ahead of print]
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
1. Metastatic castrate resistant prostate cancer (mCRPC) patients with documented disease progression:
A. If measureable: (RECIST v 1.1) progression;
Exclusion Criteria
1. Impossibility or unwillingness to take oral drugs;
2. Serious illness or medical unstable condition requiring treatment, symptomatic CNS-metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the interaction of budesonide on the plasma exposure of cabazitaxel.
- Secondary Outcome Measures
Name Time Method Assesment of safety of concomitantly administrating cabazitaxel and budesonide in terms of potential side effects