EUCTR2016-003121-42-NL进行中（未招募）1 期
A Phase I-IIa, Open label, Dose Escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous Pegylated Liposomal Dexamethasone Sodium Phosphate as Monotherapy in Patients with Metastatic Prostate Cancer - Intravenous liposomal dexamethasone monotherapy in patients with metastatic prostate cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
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;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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.Any indication of past or present tuberculosis.
- •9.Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
- •10.History of alcohol or substance abuse
- •11.Use of CYP3A4-inhibiting drugs or food (grapefruit, grapefruit juice, grapefruit-containing products, Seville oranges, or pomelo-containing products, and quinine containing drinks within 14 days prior to day –1.
- •12.Participation in an investigational drug or device study within 3 months prior to screening.
- •13.Donation of blood over 500 mL within three months prior to screening.
- •14.Vaccination within 6 weeks prior to start of treatment or planned vaccination up to 90 days after the final dose.
- •15.Unwillingness or inability to comply with the study protocol for any other reason.
研究者
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