NL-OMON47810已完成不适用
M17DOC: Multicenter safety, feasibility and pharmacokinetic phase I trial of ModraDoc006/r in patients with metastatic castration-resistant prostate cancer - M17DOC: ModraDoc006/r in CRPC
适应症
试验速览
- 阶段
- 不适用
- 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
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histological or cytological proven castration-resistant metastatic prostate cancer with an indication for systemic treatment with intravenous docetaxelat the discretion of the physician
- •2. Progressive disease defined as biochemical and/or radiological progression according to the Prostate Cancer Working group 3 recommendations
- •3. Chemotherapy naïve patients. Prior treatment with abiraterone or enzalutamide as first line therapy is allowed.
- •4. Disease evaluable for biochemical and/or radiological response
- •5. Castrate levels of testosterone
- •6. Age equal or above 18 years
- •7. Adequate haematological, renal and hepatic functions
- •8. WHO performance status of 0-2
- •9. Life expectancy above 3 months
- •10. Able and willing to swallow oral medication
- •11. Able and willing to undergo blood sampling for pharmacokinetics and assessment of CTCs.
- •12. Able and willing to give written informed consent
排除标准
- •1.Any treatment with investigational drugs, chemotherapy or immunotherapy within 28 days prior to receiving the first dose of investigational treatment. Palliative radiotherapy is allowed before and during the study as long as this is scheduled outside the DLT period (first 28 days) at least 4 days after intake of study medication and no intestinal toxicity is expected from the radiotherapy
- •2. Patients with symptomatic brain metastases. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anticonvulsant therapy for at least 6 weeks are allowed to enroll. Radiotherapy for brain metastasis must have been completed at least 6 weeks prior to start of study treatment. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening, demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive anti-epileptic drugs or corticosteroid treatment indicated for brain metastasis. Patients with a history of leptomeningeal metastases are not eligible.
- •3.Unreliable contraceptive methods.
- •4.Unresolved (> grade 1) toxicities of previous therapy, excluding alopecia.
- •5. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
- •6. Patients with a known history of hepatitis B or C;
- •7. Bowel obstructions or motility disorders that may influence the resorption of drugs as judged by the treating physician
- •8. Concomitant use of MDR and CYP3A modulating drugs such as Ca+- entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, tamoxifen, megestrol and grapefruit juice, concomitant use of HIV medications, other protease inhibitors, (non) nucleoside analogues, or St. John*s wort.
- •9. Use of Bicalutamide within 14 days prior to receiving the first dose of investigational treatment
- •10. Patients with known alcoholism, drug addiction and/or psychiatric or physiological condition which in the opinion of the investigator would impair study compliance; Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
- •11. Legal incapacity
研究者
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