Effects of the co-administration of budesonide on the plasma exposure of cabazitaxel (Jevtana??) in castrate resistant prostate cancer patients

Completed

• Conditions: Prostate cancer; 10027476

• Registration Number: NL-OMON36037
• Lead Sponsor: Medical Oncology BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

• Metastatic castrate resistant prostate cancer (mCRPC) patients with documented disease progression
o If measureable: (RECIST v 1.1) progression
o If non-measurable: documented rising PSA levels (at least 2 consecutive rises in PSA over a reference value taken at least 1 week apart) or appearance of new lesions
• Previous treatment with a docetaxel-containing regimen
• Age > 18 years;
• WHO performance * 1 (see appendix B);
• Adequate renal and hepatic functions (serum creatinin < 1.25x upper limit of normal (ULN), total bilirubin < 1.25xULN; alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) < 2.5x ULN, in case of liver metastasis < 5 ULN; alkaline phosphatase (AF) < 5xULN);
• Adequate hematological blood counts (absolute neutrophil count (ANC) > 1.5 x 109/L, platelets > 100 x 1012/L);
• Written informed consent;
• No chemotherapy within the last 4 weeks before start
• No radiotherapy within the last 4 weeks before start
• Castration, either surgically or by continued LHRH agonist therapy

Exclusion Criteria

• • Impossibility or unwillingness to take oral drugs;
• 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;
• Use of medications or dietary supplements known to induce or inhibit CYP3A (see section 5.4)
• Use of other hormonal agents than Gn-RH agonists
• Hypersensitiveness to corticosteroids
• Systemic or local bacterial, viral, fungal - or yeast infection.
• Liver cirrhosis
• Portal hypertension

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in exposure of cabazitaxel with co-administration of budesonide<br /><br>compared to exposure of cabazitaxel without co-administration of budesonide</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess side-effects of co-administration of budesonide and cabazitaxel</p><br>