metastatic castration-resistant prostate cancer
Conditions
Interventions
Trade Name: darolutamide
Pharmaceutical Form: Tablet
Trade Name: Cabazitaxel
Pharmaceutical Form: Infusion
Sponsors
Erasmus MC Cancer Institute
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the influence of darolutamide on the pharmacokinetics of cabazitaxel compared to cabazitaxel alone in mCRPC patients. ;Secondary Objective: 1. To evaluate the efficacy of cabazitaxel and darolutamide combination therapy, by means of PSA response, compared to baseline. 2. To study the pharmacokinetic profile of darolutamide. 3. To evaluate the safety of cabazitaxel and darolutamide combination therapy.;Primary end point(s): AUC of cabazitaxel;Timepoint(s) of evaluation of this end point: After 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Other pharmacokinetic parameters of cabazitaxel, including clearance (CL), maximum concentration (Cmax), time to maximum concentration (Tmax) and half-life (t½). 2. Pharmacokinetic parameters of darolutamide, including AUC, CL, Cmax, Tmax and t½. 3. The incidence and severity of side-effects during treatment with cabazitaxel and darolutamide. 4. PSA response, as defined by the difference between PSA levels after combination treatment with cabazitaxel and darolutamide and PSA levels at baseline.;Timepoint(s) of evaluation of this end point: End of the study | — |
Countries
Netherlands
Contacts
Public ContactA.H.J. Mathijssen
Erasmus MC Cancer Institute
Outcome results
None listed