EUCTR2019-001512-34-IT进行中（未招募）1 期
PHASE 2, OPEN-LABEL, SINGLE-ARM TRIAL OF TRASTUZUMAB DERUXTECAN (DS-8201A) IN HER2-POSITIVE, UNRESECTABLE OR METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION (GEJ) ADENOCARCINOMA SUBJECTS WHO HAVE PROGRESSED ON OR AFTER A TRASTUZUMAB-CONTAINING REGIMEN - DS-8201a in HER2-positive Gastric Cancer that cannot be surgically removed or has spread
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
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
- •- Men or women =18 years old (Please follow local regulatory requirements if the legal age of consent for study participation is >18 years old.)
- •- Has pathologically documented gastric or GEJ cancer that is:
- •- Unresectable or metastatic
- •- Centrally confirmed HER2-positive disease (immunohistochemistry [IHC]3+, IHC2+/in-situ hybridization [ISH]+) as determined according to American Society of Clinical Oncology – College of American Pathologists (ASCO-CAP) guidelines based on a new tissue sample obtained after progression on or after a trastuzumabcontaining regimen. If a tissue sample was already collected after discontinuation of first-line treatment with a trastuzumab-containing regimen, it is acceptable to consider this a new biopsy for the purpose of this study.
- •- Experienced disease progression during or after first-line therapy with a trastuzumab-containing regimen (brand or approved biosimilar). Note: Prior adjuvant therapy with a trastuzumab-containing regimen can be counted as a line of therapy if the subject progressed on or within 6 months of completing adjuvant therapy.
- •- Has at least 1 measurable lesion per RECIST v1.1 as confirmed by independent central review.
- •- Has left ventricular ejection fraction (LVEF) =50% within 28 days before enrollment per echocardiogram (ECHO)/multigated acquisition (MUGA) scan.
- •- Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4.5 months after the last dose of study drug.
- •- Adequate renal function, defined as creatinine clearance =30 mL/min, as calculated using the Cockcroft-Gault equation.
- •- Adequate hepatic function, defined as total bilirubin =1.5 × upper limit of normal (ULN); serum albumin =2.8 g/dL; aspartate transaminase (AST)/alanine transaminase (ALT) =3 × ULN in the absence of liver metastases or =5 × ULN in the presence of liver metastases.
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •- Use of anticancer therapy after first-line treatment with a trastuzumabcontaining regimen.
- •- Uncontrolled or significant cardiovascular disease, including any of the following:
- •- History of myocardial infarction (MI) within 6 months before enrollment
- •- History of symptomatic congestive heart failure (New York Heart Association Class II to IV)
- •- Troponin levels consistent with MI as defined according to the manufacturer within 28 days prior to enrollment
- •- History of unstable angina or serious cardiac arrhythmia requiring treatment
- •- Corrected QT interval (QTc) prolongation to >470 ms (females) or >450 ms (male) based on Screening triplicate 12-lead electrocardiogram (ECG)
- •- History of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required corticosteroid therapy or has current ILD/pneumonitis or is suspected to have such diseases by imaging during Screening.
- •- Clinically significant corneal disease, in the opinion of the Investigator.
- •- Pleural effusion, ascites, or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART). (Drainage and CART are not allowed within 2 weeks prior to or during Screening.)
- •- Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- •- Subjects with clinically inactive brain metastases may be included in the study.
- •- Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered
- •from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment (1 week for stereotactic radiotherapy).
研究者
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