No registrations found.
ID
Source
Brief title
Health condition
metastatic castration-resistant prostate cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the influence of darolutamide on the pharmacokinetics of cabazitaxel compared to cabazitaxel alone in mCRPC patients.
Secondary outcome
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.
Background summary
Darolutamide (Nubeqa) is a novel androgen receptor antagonist drug for the treatment of non-metastatic castration resistant prostate cancer (CRPC), approved by the FDA and EMA. It does not inhibit major CYP enzymes or major transporters at clinically relevant concentrations, so it is thought to be less sensitive for drug-drug interactions (DDIs), compared to other agents. Several clinical studies investigating the efficacy of combining hormonal therapy, like androgen receptor antagonists, with chemotherapy in metastatic CRPC patients are ongoing and the first data are promising. However, due to DDIs between these agents, which likely affect the anti-tumor activity of the treatment, there is a need for testing new, potentially more effective chemo-hormonal combination regimens. In this study we will determine the influence of darolutamide on the pharmacokinetics of cabazitaxel compared to cabazitaxel alone in mCRPC patients.
Study objective
Darolutamide (Nubeqa) is a novel androgen receptor antagonist drug for the treatment of non-metastatic castration resistant prostate cancer (CRPC), approved by the FDA and EMA. It does not inhibit major CYP enzymes or major transporters at clinically relevant concentrations, so it is thought to be less sensitive for drug-drug interactions (DDIs), compared to other agents.
Study design
2022
Intervention
Darolutamide 600mg b.i.d. for 12 weeks
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8611 |
| CCMO | NL73182.056.20 |
| OMON | NL-OMON50053 |