JPRN-jRCT2031210299招募中1 期
A Phase 1 Study of DSP-0390 in Patients with Recurrent High-Grade Glioma
Tada Tomohiro0 个研究点目标入组 70 人开始时间: 2021年9月7日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Estimated life expectancy >= 3 months
- •2.Recovery from toxic effects of prior therapy to NCI CTCAE v5.0 Grade 1 (nonhematologic toxicities) or Grade <=2(hematologic toxicities, except deep vein thrombosis)
- •3.Karnofsky Performance Status (KPS) score >= 70%
- •4.Adequate organ function as determined by:
- •a. Absolute Neutrophil >=1500/microliter (may not use G-CSF or GM CSF)
- •b. Platelet >=100 * 10^3/microliter
- •c. Hemoglobin >=9 g/dL (may not transfuse or use erythropoietin to obtain this Hgb level)
- •d. Creatinine Clearance >= 40ml/min (Cockcroft-Gault)
- •e. Total bilirubin <=1.5 times ULN (or <= 2 times ULN for patients with known Gilbert syndrome)
- •f. AST <= 3 times ULN
- •g. ALT <= 3 times ULN
- •h. INR, PT, PTT, or aPTT <=1.5 x ULN Note: The use of anticoagulants is permitted as long as the PT/(a)PTT is within therapeutic limits (according to the local institution standard) and the patient has been on a stable anticoagulant regimen for at least 2 weeks prior to the first study Day 1
- •5.If on antiepileptic drug; dose must be stable and no seizures 14 days prior to study Day 1
- •6.If on corticosteroids at baseline, dose must be stable or decreasing for at least 5 days prior to study Day 1. For the dose expansion part of the study, the dose must be <= 4 mg dexamethasone per day (or equivalent dose if other corticosteroids are used). A higher stable dose of corticosteroids, if used as HRT, may be allowed upon discussion with the Medical Monitor.
- •7.Females of childbearing potential must have a negative serum or urine pregnancy test
- •8.Male or female patients of child-producing potential must agree to use contraception or use prevention of pregnancy measures or agreement to refrain completely from heterosexual intercourse during the study and for 6 months (females & males) after the last dose of study drug
排除标准
- •1.Prior therapy with bevacizumab or other anti-vascular endothelial growth factor (-VEGF) treatments within 3 months prior to study Day 1
- •2.Multifocal disease, leptomeningeal metastasis, or extracranial metastasis
- •3.Abnormal ECGs that are clinically significant, including those where QT prolongation (QTcF>450 msec for males and >470 msec for females); and/or history of Torsade de Pointes
- •4.Left ventricular ejection fraction <40% as determined by ECHO or MUGA
- •5.Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally
- •6.Know active Chrohn's or other inflammatory bowel disease
- •7.History of another primary cancer within the 2 years prior to study Day 1, except for the following: nonmelanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer that has been removed or curatively treated
- •8.A known active acute or chronic infection including, but not limited to, human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) [Patients who have completed a course of anti-viral treatment for HVC are eligible provided than an HCV polymerase chain reaction shows no detectable virus]
- •9.Pregnant or breastfeeding. Male or female patients of child-producing potential must agree to use contraception or use prevention of pregnancy measures or agreement to refrain completely from heterosexual intercourse during the study and for 6 months (females & males) after the last dose of study drug
- •10.The presence of any active retinal abnormality determined by screening tests using visual acuity, visual field, fundoscopy, and OCT
- •11.Significant cardiovascular disease, including NYHA Class III or IV congestive heart failure, myocardial infarction, unstable angina, poorly controlled cardiac arrhythmias, or stroke in the preceding 6 months prior to study Day 1
- •12.Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements, or disorders associated with significant immunocompromised state
- •13.Major surgical procedure, surgical resection, open biopsy, or significant traumatic injury within 4 weeks prior to study Day 1 or anticipation of need for major surgical procedure during the course of the study
- •14.Minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to study Day 1
- •15.Evidence of CNS hemorrhage on baseline MRI or CT scan (except for postsurgical, asymptomatic, Gr 1 hemorrhage that has been stable at least 4 weeks for enrolled patients)
- •16.Chemotherapy or investigational anticancer therapy administered within 4 weeks (except 6 weeks for nitrosoureas and immunotherapy, or 8 weeks for an implanted nitrosoureas wafer) prior to study Day 1
- •17.Radiotherapy within 12 weeks prior to study Day 1, unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are 2 MRIs (performed 8 weeks apart) confirming progressive disease
- •18.Concurrent use of prohibited medications: methylprednisolone, prednisone, carbamazepine, phenytoin, phenobarbital, and other strong or moderate CYP3A4 inhibitors or inducers, and strong CYP2D6 inhibitors. These should be discontinued 1 week or 5 half-lives (whichever is greater) prior to study Day 1
- •19.Concurrent treatment with Tumor Treatment Field (Optune) is not allowed. Patients must stop Optune 1 day prior to the first dose of study drug. Any wo
研究者
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