EUCTR2020-000096-21-AT进行中（未招募）1 期
A Phase 3 Multicenter Study of Gleolan (Aminolevulinic Acid Hydrochloride) to EnhanceVisualization of Tumor in Patients with Newly Diagnosed or Recurrent Meningiomas - MEN-301
X Development Corp.0 个研究点目标入组 100 人开始时间: 2020年7月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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.A pre-operative MRI within 30 days of study enrollment documenting a suspected meningioma or suspected recurrence of a meningioma for which a meningioma resection is indicated and has been planned.
- •2. Adult age =18 years
- •3. Patient must have normal organ and bone marrow function and be appropriate surgical canditates per site SOC.
- •4. Patient must have recording of each Parameter as defined below:
- •BilirubinBelow upper limit of normal
- •AST (SGOT)< 2.5 X institutional upper limit of normal
- •ALT (SGPT)< 2.5 X institutional upper limit of normal
- •CreatinineBelow upper limit of normal
- •Creatinine clearance >60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
- •5. The Patient/patient´s legally authorized representative (LAR) will have to demonstrate the ability to understand, informed consent, and the willingness and ability to sign a written informed consent document. The study consent documents will be prepared in English and German and Spanish. Translation for non-English, non-German, or non-Spanish speaking participants will be provided as appropriate by Institution.
- •6.WOCBP and men participating must agree to use highly effective forms of contraception, and men must also agree not to donate sperm for the duration of treatment, and for at least 42 days after the one time use of the study drug
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. History of allergic reactions attributed to compounds of similar chemical/biologic composition to Gleolan.
- •2. Known or documented personal or family history of porphyria.
- •3. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness
- •4. Patient has had a meningioma resection or radiation treatment within 90 days of informed consent
- •5. Social or medical situations that would limit compliance with study requirements (e.g. ability to travel for follow-up or inability to obtain appropriate pre-op MRI (e.g. cardiac pacemaker)
- •6. Women who are pregnant or plan to become pregnant during study participation.
- •7. Prior history of gastrointestinal perforation, diverticulitis, and or/peptic ulcer disease.
- •8. Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment or within 5 plasma half-life of the preceding study drug, whatever is longer.
- •9. Simultaneous use of other potentially phototoxic substances (St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period
- •10. Unwillingness by patient to sign consent or return for subsequent visits following surgery
- •11. Any condition that in the opinion of the Investigator would exculde the patient as a viable candidate for this study
- •12. Patient undergoing planned embolization prior to meningioma resection that is separate from the meningioma resection procedure itself.
研究者
相似试验
进行中（未招募）
1 期
Study on how effective Gleolan is as a maker for tumor cells during brain surgeryMedDRA version: 21.1Level: PTClassification code 10027191Term: MeningiomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MeningiomaEUCTR2020-000096-21-DEX Development Corp.100
已完成
3 期
Gleolan for Visualization of Newly Diagnosed or Recurrent MeningiomaMeningiomaNCT04305470NX Development Corp108
招募中
3 期
Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)Ovarian CancerNCT05804370NX Development Corp170
进行中（未招募）
1 期
A Phase 3, Open-label Study of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy (TrustTSC OLE)Tuberous Sclerosis Complex (TSC) related epilepsyMedDRA version: 20.0Level: LLTClassification code: 10032062Term: Other forms of epilepsy with intractable epilepsy Class: 10029205CTIS2022-503067-15-00Marinus Pharmaceuticals Inc.166
撤回
3 期
Study to Assess Acute Vasodilation Response of Inhaled Nitric OxidePulmonary Arterial HypertensionNCT02436512Geno LLC