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积极招募
A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
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简短的总结
本研究将评估其疗效, 安全, optimal dose and ADA and NAbs development of TRK-950 at two separate dose levels in combination with ramucirumab and paclitaxel (RAM+PTX) as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma.
主要目的
研究类型
阶段
资格
性别
健康的志愿者
最低年龄
最高年龄
入选标准:
- 组织学或细胞学证实为转移性, 或局部晚期且不能切除的胃或胃j腺癌.
- 患者有资格接受Ramucirumab +紫杉醇治疗.
- Documented objective radiographic or clinical disease progression (e.g., any new or worsening malignant effusion documented by ultrasound examination) which may be confirmed by pathologic criteria (histology and/or cytology) if appropriate, 治疗期间或治疗后. The prior treatment must meet one of the following criteria with the following treatment history:
- First treatment for metastatic disease or locally advanced disease without experiencing adjuvant / neo-adjuvant treatment, which progressed during treatment or within 4 months after the last dose of treatment
- Adjuvant / neo-adjuvant treatment which progressed more than 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during the treatment or within 4 months after the last dose of treatment
- Adjuvant / neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment
- Adjuvant / neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during treatment or within 4 months after the last dose of treatment
- 存在原发性或转移性疾病，根据RECIST v1可测量.1 . CT扫描.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- 预期寿命至少3个月.
- 年龄在美国和日本≥18岁，在韩国≥19岁.
- 经irb批准的知情同意书.
- Adequate organ function from specimens collected within 14 days prior to Day 1.
- 对于有生育潜力的男女来说, the use of effective contraceptive methods during the study and for 6 months after the last dose of TRK-950.
- 所有 patients must sign a pre-screening consent to assess tumor tissue to determine eligibility. Tumor tissue must be evaluable for CAPRIN-1 staining at a CLIA certified laboratory and meet or exceed the cutoff value (30% at ≥ 2+ staining) as defined in the expression level requirements.
排除标准:
- 既往有ramucirumab或紫杉醇治疗史.
- HER2阳性胃腺癌或胃腺癌.
- 随机分组前28天内进行大手术.
- Baseline corrected QT (QTc) interval of > 470 msec for females and > 450 msec for males calculated using Fridericia's formula.
- New York Heart Association (NYHA) Class II - IV symptomatic congestive heart failure, 或有症状或控制不良的心律失常.
- 患者有过动脉血栓事件, 包括心肌梗塞, 不稳定性心绞痛, 脑血管意外, 或者短暂性脑缺血发作, 随机分组前3个月内.
- The patient has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Clinically symptomatic venous thromboembolism or current treatment with anti-coagulants. (Patients receiving prophylactic and low-dose anticoagulation therapy are eligible provided that the coagulation parameter defined in the Inclusion Criterion 9 is met.)
- Uncontrolled arterial hypertension ≥ 150 mmHg (systolic) or ≥ 90 mmHg (diastolic) despite standard medical management.
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- 孕妇或哺乳期妇女.
- 2周内进行放射治疗, 或者用化疗治疗, 免疫疗法, 靶向治疗, or investigational therapy within 4 weeks prior to randomization (within 2 weeks for Oral FU (S1 and capecitabine)).
- 病人有明显的出血性疾病, 血管炎, or had a significant bleeding episode from the gastrointestinal tract 随机分组前3个月内.
- 临床显著腹水, 在过去的三个月里做过穿刺, 或者接受常规的穿刺程序.
- History of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
- 病人伤口严重或无法愈合, 消化性溃疡, 或在随机分组前28天内发生骨折.
- 病人有肠梗阻, history or presence of inflammatory enteropathy or extensive intestinal resection (e.g., hemicolectomy or extensive small intestine resection with chronic diarrhea), 克罗恩氏病, 溃疡性结肠炎, 或者慢性腹泻.
- 已知活动性感染艾滋病毒、乙型肝炎或丙型肝炎. Patients with a history of hepatitis B or C are allowed if HBV DNA or Hep C RNA are undetectable.
- The patient is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Patients who have recently discontinued dosing of study drug are eligible to participate as long as the final dose of study drug was ≥ 28 days from randomization for participation in this study. Patients participating in surveys or observational studies are eligible to participate in this study.
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研究统计数据
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23-001647
类别
食道癌
胃癌
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- 皇冠hga025大学洛杉矶分校韦斯特伍德