NL-OMON45330已完成不适用
A Phase I-IIa, Open label, Single Center, Dose Escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous Pegylated Liposomal Dexamethasone Sodium Phosphate as Monotherapy in Patients with Castration Resistant Metastatic Prostate Cancer - Liposomal Dexamethasone in metastatic prostate cancer
Enceladus Pharmaceuticals B.V.0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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 64（—）
入选标准
- •1. Adult patients with mCRPC and one or more metastases in the bone, confirmed by bone scintigraphy, MRI or CT-scan within 6 weeks before first dosage;
- •2. Able to participate, and willing to give written informed consent and to comply with the study restrictions;
- •3. Body mass index (BMI) of 18 kg/m2 or higher (inclusive) and a minimum weight of 50 kg;
- •4. Not yet, or no longer being eligable for other, registered therapy other than corticosteroids.
- •5. Live expectancy in good clinical condition (WHO 0-1) and live expectancy of more than 3 months.
排除标准
- •1. Concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
- •2. Contraindication for glucocorticoids as judged by investigator
- •3. Use of systemic glucocorticosteroids within 4 weeks before first dosage, with exception of topical and inhalation steroids.
- •4. Any confirmed and clinically significant allergic reactions (urticaria or anaphylaxis; non-active hay fever is acceptable). Allergy or hypersensitivity against any drug, including any component of the study drug, biologic therapy or IV radiocontrast agent.
- •5. Clinically significant abnormalities, as judged by the investigator, following a detailed medical history, a physical examination including vital signs, 12-lead ECG and laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant.
- •6. History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder that may aggravate due to study participation and jeopardize the health status of the patient.
- •7. Any infection within 1 month prior to the anticipated dosing day.
- •8. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
- •9. History of alcohol or substance abuse
- •10. Use of CYP3A4-inhibiting drugs or food (grapefruit, grapefruit juice, grapefruit-containing products, Seville oranges, or pomelo-containing products, and quinine containing drinks within 11 days prior to day of dosing.
- •11. Participation in an investigational drug or device study within 3 months prior to screening.
- •12. Donation of blood over 500 mL within three months prior to screening.
- •13. Vaccination within 6 weeks prior to start of treatment or planned vaccination up to 90 days after the final dose.
- •14. Unwillingness or inability to comply with the study protocol for any other reason.
- •15. Expected fulminant progression of disease
研究者
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