Effects of budesonide on the toxicity of cabazitaxel in metastatic castrate-resistant prostate cancer.

Completed

• Conditions: budesonide; diarrhea; cabazitaxel; prostate cancercabazitaxel; diarree; prostaatkanker

• Registration Number: NL-OMON27669
• Lead Sponsor: Dept. of Medical OncologyErasmus MC Rotterdam – Daniel den Hoed Cancer CenterGroene Hilledijk 3013075 EA RotterdamThe Netherlands

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

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

1. Metastatic castrate resistant prostate cancer (mCRPC) patients with documented disease progression;

2. If measureable disease: documented disease progression as defined in RECIST criteria v 1.1;

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
The effects of budesonide on the incidence of cabazitaxel induced diarrhea.

Secondary Outcome Measures

Name	Time	Method
1. The effects of budesonide on other side effects of cabazitaxel (e.g. myelotoxicity);<br /><br>2. Pharmacogenetics of cabazitaxel.