EUCTR2021-000068-30-SE进行中（未招募）1 期
An open-label, multi-center, phase I/II study of MFA-370 in patients with metastatic urothelial cancer - MANHATTA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- 性别
- All
入选标准
- •1. Signed Informed Consent Form before any screening procedures
- •2. = 18 years of age on the day of giving informed consent
- •3. Confirmed current metastatic urothelial carcinoma of the bladder, including the urethra and upper urinary tract. The patient needs to have progressive disease and/or symptomatic metastatic disease that is unresponsive to standard therapy. The patient must have received all available approved therapies before being eligible for the study unless contraindications or intolerance exist for one or several of them
- •4. At least one lesion of measurable disease as defined by RECIST1.1 criteria based on CT or MRI scan made within 2 weeks before ibuprofen-start at Day -7
- •5. World Health Organization (WHO) performance status 0-2
- •6. Life expectancy =12 weeks
- •7. Patients with reproductive potential will need to use accepted and highly effective means of contraception from study entry until at least 6 weeks for females (women of childbearing potential, WOCP) and 3 months for males after study drug discontinuation
- •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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •1. Known CNS metastatic lesions, or evidence of impaired blood-brain barrier as assessed by the investigator
- •2. Have signs or symptoms of active COVID-19 infection or a positive COVID-19 PCR test during the screening period
- •3. Impaired renal function by estimated Glomerular Filtration Rate (eGFR) <30 ml/min as per local assessment
- •4. Laboratory values (hematology and biochemistry) within specified ranges to show appropriate organ function
- •5. Clinically significant cardiac disease,
- •6. Untreated or uncontrolled hypertension
- •7. An underlying medical condition that precludes the ability to take oral medication daily
- •8. Concomitant therapy that precludes enrolment:
- •- Concomitant use of other nonsteroidal anti-inflammatory drugs (NSAIDs). Wash out and change of treatment is allowed during the screening period and up to one week before visit 2
- •- Treatment in a prior investigational study within four weeks before enrolment or within five half-lives of the investigational product, whichever is longer, before starting study drug (visit 2)
- •9. The patient has had biologic, hormonal, anti-neoplastic chemotherapy within 4 weeks prior to screening except for medications with half-lives <5.5 days, or radiation therapy other than palliative treatment within 2 weeks
- •10. Hypersensitivity to ibuprofen, ivermectin, avermectin, or any of the excipients listed in section 6.1 in respective SmPC
- •11. Any bleeding disorder or condition where there is an increased risk of bleeding
- •12. A history of allergic reactions following intake of acetylsalicylic acid or NSAIDs
- •13. A history of gastrointestinal bleeding or perforation
- •14. Active or recurrent gastrointestinal ulcer
- •15. The known or suspected presence of a tropical parasitic infection, such as strongyloidiasis, onchocerciasis, or any other for which treatment with ivermectin is indicated
- •16. Major surgery within 14 days before enrolment. (Note: trans-urethral resection of bladder tumor is not considered major surgery)
- •17. For female patients of childbearing potential – pregnancy, as confirmed by a serum pregnancy test at screening, or breast-feeding
- •18. Any other severe, acute, or chronic medical condition that would interfere with the conduct of the study or interpretation of the study results as judged by the investigator
- •19. The patient has already participated in the study or been a screening failure
研究者
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