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…
ID
Bron
Verkorte titel
Aandoening
metastatic castration-resistant prostate cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To determine the influence of darolutamide on the pharmacokinetics of cabazitaxel compared to cabazitaxel alone in mCRPC patients.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
2022
Onderzoeksproduct en/of interventie
Darolutamide 600mg b.i.d. for 12 weeks
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8611 |
| CCMO | NL73182.056.20 |
| OMON | NL-OMON50053 |