Study on the pharmacokinetic interaction between cabazitaxel and darolutamide in metastatic castration-resistant prostate cancer (mCRPC) patients.

Completed

Conditions: metastatic castration-resistant prostate cancer

Registration Number: NL-OMON28448

Lead Sponsor: Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 17

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)

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the influence of darolutamide on the pharmacokinetics of cabazitaxel compared to cabazitaxel alone in mCRPC patients.

Secondary Outcome Measures

Name	Time	Method
1. To evaluate the efficacy of cabazitaxel and darolutamide combination therapy, by means of PSA response, compared to baseline.<br>2. To study the pharmacokinetic profile of darolutamide.<br>3. To evaluate the safety of cabazitaxel and darolutamide combination therapy.