Primary objectives:- To study the potential interaction of budesonide on the plasma exposure of cabazitaxelSecondary objectives:- To test the safety of concomitantly administrating cabazitaxel and budesonide in terms of potential side effects
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in exposure of cabazitaxel with co-administration of budesonide
compared to exposure of cabazitaxel without co-administration of budesonide
Secondary outcome
To assess side-effects of co-administration of budesonide and cabazitaxel
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. Budesonide is planned on being tested as a
preventative strategy for diarrhea in cabazitaxel treatment in a large
randomized, double blind, placebo controlled multicenter phase II trial.
Study objective
Primary objectives:
- To study the potential interaction of budesonide on the plasma exposure of
cabazitaxel
Secondary objectives:
- To test the safety of concomitantly administrating cabazitaxel and budesonide
in terms of potential side effects
Study design
This is a randomized crossover pharmacokinetic study intended to investigate
the effects of co-administration of budesonide on plasma exposure of
cabazitaxel. The study will be performed at the Erasmus MC- location Daniel in
Rotterdam. It is anticipated that the study will be completed in 6 months time.
Eighteen evaluable patients will finally be included in this trial. Patients
will be randomized at study entry to avoid bias in cycle sequence.
Arm A: first one treatment cycle of cabazitaxel (25 mg/m2) followed by a
treatment cycle of cabazitaxel (25 mg/m2) with budesonide (9 mg daily).
Arm B: first one treatment cycle of cabazitaxel (25 mg/m2) with budesonide (9
mg daily) followed by a treatment cycle with only cabazitaxel (25 mg/m2).
Intervention
9mg budesonide once daily 9mg during 12 days
Study burden and risks
Patients wil be asked for 13 blood samples during 2 cycles of cabazitaxel
treatment (with/without budesonide). In the context of the 13 blood samples
patients will be hospitalized for 2 days.
Budesonide has a favourable safety profile, so no serious adverse events are
expected.
Patients will be asked to fill out a patient diary with information on time of
budesonide intake, side effects (especially diarrhea) and concomitant
medication use.
Clusterbureau 2, kamer Z-126, postbus 2040
3000 CA Rotterdam
NL
Clusterbureau 2, kamer Z-126, postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2011-000617-39-NL |
| CCMO | NL35740.078.11 |