EUCTR2013-001277-24-GR进行中（未招募）1 期
A Multicenter, Phase 2, Single Arm, Two Cohort Study Evaluating the Efficacy, Safety, and Pharmacokinetics of AMG 337 in Subjects with MET Amplified Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma or Other MET Amplified Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 140
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
- •- Subjects have provided informed consent/assent prior to initiation of any study-specific activities/procedures or subject’s legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of
- •the investigator, may compromise the ability of the subject to give written informed consent.
- •- Subjects have agreed to and are able to daily self-administer AMG 337 orally as a whole capsule
- •Demographic
- •- Male or female subjects = 18 years of age at the time of enrollment
- •Disease-related
- •- Subjects must have a pathologically confirmed advanced G/GEJ/E
- •adenocarcinoma (Cohort 1) or other solid tumor (Cohort 2) for which the subject has received prior therapy for advanced disease, or for which no standard therapy exists, or the subject refuses standard therapy
- •- Tumor MET amplified by protocol-specified centralized testing. Testing may be performed by central laboratory prior to main study informed consent if subject signs a separate consent for the purposes of tumor tissue testing
- •- Availability of recent (preferred) or archival tumor tissue
- •- Measurable disease per RECIST 1.1 guidelines. Cohort 2 may include up to 10 subjects with advanced MET amplified, G/GEJ/E adenocarcinoma with non-measurable tumor per RECIST v1.1
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •- Adequate organ function as evidenced by the following laboratory studies within 28 days prior to enrollment:
- •? Hemoglobin = 9 g/dL
- •? Absolute neutrophil count = 1.5 x 109/L
- •? Platelet conut = 100 x 109/L
- •? Creatinine clearanc=e 50 mL/minute (calculated or measured)
- •? Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x upper limit of normal (ULN) or AST and ALT = 5.0 x ULN if liver metastases are present
- •? Total bilirubin (TBL) = 1.5 x ULN
- •? International normalized ratio (INR) = ULN
- •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 84
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 56
排除标准
- •- Known central nervous system metastases. Subject is a candidate for curative surgery or definitive chemoradiation. Peripheral edema > grade 1.
- •Currently receiving any anti-tumor treatments, or less than 14 days prior to enrollment since ending anti-tumor treatment.
- •- Therapeutic or palliative radiation therapy less than 14 days prior to study day 1 or still experiencing toxicities from radiation therapy or radiation therapy administered to the only site of
- •- Use of a strong CYP3A4 inhibitor less than 14 days prior to study day 1.
- •- Ingestion of grapefruit or grapefruit products and other foods that are known to inhibit CYP3A4 less than 7 days prior to study day 1.
- •- Use of strong CYP3A4 inducers less than 14 days prior to study day 1.
- •- Use of St. John’s Wort and other herbal supplements known to induce CYP3A4 less than 14 days prior to study day 1.
研究者
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