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


- candidate number9303
- NTR NumberNTR2840
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-apr-2011
- Secondary IDs11-091 METC Erasmus Medical Center
- Public TitleStudying the influence of budesonide on the exposure of cabazitaxel (Jevtana®) in patients with prostate cancer.
- Scientific TitleEffects of the co-administration of budesonide on the plasma exposure of cabazitaxel (Jevtana®) in castrate resistant prostate cancer patients.
- ACRONYMN/A
- hypothesisBudesonide does not alter the exposure of cabazitaxel in castrate resistant prostate cancer patients.
- Healt Condition(s) or Problem(s) studiedProstate cancer, Cabazitaxel, Budesonide
- Inclusion criteria1. 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 18 years;
4. WHO performance 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) 1.5 x 109/L, platelets 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-apr-2011
- planned closingdate31-dec-2011
- Target number of participants18
- InterventionsAdministration 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.
- Primary outcomeEvaluation of the interaction of budesonide on the plasma exposure of cabazitaxel.
- Secondary outcomeAssesment of safety of concomitantly administrating cabazitaxel and budesonide in terms of potential side effects
- TimepointsDuring two courses of cabazitaxel 13 blood samples for pharmacokinetic analysis are drawn to asses the effect of budesonide administration on cabazitaxel plasma exposure.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. MSc Anne-Joy M. Graan, de
- CONTACT for SCIENTIFIC QUERIESMD PhD Ron H.J. Mathijssen
- Sponsor/Initiator Erasmus Medical Center, Daniel den Hoed Cancer Center
- Funding
(Source(s) of Monetary or Material Support)
Sanofi-Aventis
- PublicationsNieuweboer 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]
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD4-apr-2011 - 12-okt-2016


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