NL-OMON50053已完成2 期
Study on the pharmacokinetic interaction between cabazitaxel and darolutamide in metastatic castration-resistant prostate cancer (mCRPC) patients. - CABADARO study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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)
排除标准
- •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.
研究者
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