Studying the influence of budesonide on the exposure of cabazitaxel (Jevtana®) in patients with prostate cancer.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21762

Enrollment

Registered

2011-04-04

Start date

2011-04-11

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer cabazitaxel budesonide

Interventions

Administration of budesonide during 12 days to asses a possible interaction between cabazitaxel and budesonide. Budesonide will be administered orally 3 times a day 3 mg through entocort capsules. The

Eligibility

Inclusion criteria

Inclusion criteria: 1. Metastatic castrate resistant prostate cancer (mCRPC) patients with documented disease progression: A. If measureable: (RECIST v 1.1) progression; B. 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. 2. Previous treatment with a docetaxel-containing regimen; 3. Age ¡Ý 18 years; 4. WHO performance ¡Ý 1; 5. 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); 6. Adequate hematological blood counts (absolute neutrophil count (ANC) ¡Ý 1.5 x 109/L, platelets ¡Ý 100 x 1012/L); 7. Written informed consent; 8. No chemotherapy within the last 4 weeks before start; 9. No radiotherapy within the last 4 weeks before start; 10. Castration, either surgically or by continued LHRH agonist therapy.

Exclusion criteria

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; 3. Use of medications or dietary supplements known to induce or inhibit CYP3A; 4. Use of other hormonal agents than Gn-RH agonists; 5. Hypersensitiveness to corticosteroids; 6. Systemic or local bacterial, viral, fungal - or yeast infection; 7. Liver cirrhosis; 8. Portal hypertension.

Design outcomes

Primary

Measure	Time frame
Evaluation of the interaction of budesonide on the plasma exposure of cabazitaxel.	—

Secondary

Measure	Time frame
Assesment of safety of concomitantly administrating cabazitaxel and budesonide in terms of potential side effects	—

Contacts

Public ContactAnne-Joy M. Graan, de

Groene Hilledijk 301

a.degraan@erasmusmc.nl+31 (0)10 7041338

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)

Studying the influence of budesonide on the exposure of cabazitaxel (Jevtana&reg;) in patients with prostate cancer.