No registrations found.
ID
Source
Brief title
Health condition
prostate cancer
cabazitaxel
budesonide
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluation of the interaction of budesonide on the plasma exposure of cabazitaxel.
Secondary outcome
Assesment of safety of concomitantly administrating cabazitaxel and budesonide in terms of potential side effects
Background summary
The aim of this study is to study a potential pharmacological interaction between budesonide and cabazitaxel to ensure the safety of concomitantly administrating these 2 agents.
Study objective
Budesonide does not alter the exposure of cabazitaxel in castrate resistant prostate cancer patients.
Study design
During two courses of cabazitaxel 13 blood samples for pharmacokinetic analysis are drawn to asses the effect of budesonide administration on cabazitaxel plasma exposure.
Intervention
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 control group will only receive cabazitaxel.
Anne-Joy M. Graan, de
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041338
a.degraan@erasmusmc.nl
Anne-Joy M. Graan, de
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041338
a.degraan@erasmusmc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2703 |
| NTR-old | NTR2840 |
| Other | METC Erasmus Medical Center : 11-091 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |