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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50053

Enrollment

Registered

2020-04-07

Start date

2020-09-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic castration-resistant prostate cancer

Interventions

Patients will start on day 1 with cabazitaxel, which will be administered once every 3 weeks (one cycle) in 20 mg/m2, according to standard of care. Darolutamide 600 mg b.i.d. will be added on day 2

Eligibility

Age

18 Years to 99 Years

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)

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

Design outcomes

Primary

Measure	Time frame
In this exploratory study, the influence of darolutamide on the pharmacokinetics of cabazitaxel will be determined. Each patient will be its own control. The primary study endpoint is the Area Under the plasma concentration time Curve (AUC) of cabazitaxel, where a comparison will be made between the AUC of cabazitaxel monotherapy and the AUC of cabazitaxel with darolutamide.	—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)