Study on the pharmacokinetic interaction between cabazitaxel and darolutamide in metastatic castration-resistant prostate cancer (mCRPC) patients.
- Conditions
- Metastatic castration-resistant prostate cancer10038597
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. Age * 18 years;
2. Patients with a confirmed diagnosis of mCRPC with an indication for
cabazitaxel treatment at the standard dose of 20 mg/m2.
3. WHO performance * 1.
4. Able and willing to sign the Informed Consent Form prior to screening
evaluations
5. Adequate baseline patient characteristics (complete blood count, serum
biochemistry which involves sodium, potassium, creatinine, calculation of
creatinine clearance, AST, ALT, gamma glutamyltranspeptidase, lactate
dehydrogenase, ALP, Total bilirubin, Albumin, glucose)
1. Use of (over the counter) medication or (herbal) supplements which can
interact with either cabazitaxel or darolutamide, e.g. by induction or
inhibition of CYP3A4 or P-gp. Dexamethasone and prednisone are allowed.
2. Patients with known impaired drug absorption (e.g. gastrectomy and
achlorhydria)
3. Known serious illness or medical unstable conditions that could interfere
with this study requiring treatment (e.g. HIV, hepatitis, Varicella zoster or
herpes zoster, organ transplants, kidney failure (GFR<60), serious liver
disease (e.g. severe cirrhosis), cardiac and respiratory diseases)
4. Treatment with abiraterone, enzalutamide, apalutamide or darolutamide six
weeks prior to day 1 of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In this exploratory study, the influence of darolutamide on the<br /><br>pharmacokinetics of cabazitaxel will be determined. Each patient will be its<br /><br>own control. The primary study endpoint is the Area Under the plasma<br /><br>concentration time Curve (AUC) of cabazitaxel, where a comparison will be made<br /><br>between the AUC of cabazitaxel monotherapy and the AUC of cabazitaxel with<br /><br>darolutamide.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. To evaluate the efficacy of cabazitaxel and darolutamide combination<br /><br>therapy, by means of PSA response, compared to baseline.<br /><br>2. To study the pharmacokinetic profile of darolutamide.<br /><br>3. To evaluate the safety of cabazitaxel and darolutamide combination therapy.</p><br>
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