A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 when Used in Combination with Ramucirumab and Paclitaxel in Patients with Gastric Cancer

Mori Yoshitaka0 个研究点目标入组 146 人开始时间: 2023年9月4日最近更新: 2024年4月1日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 146

研究概览入排标准研究者记录与标识符相似试验

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

•Histologically or cytologically confirmed metastatic, or locally advanced and unresectable gastric or GEJ adenocarcinoma.
•- The patient is eligible to receive RAM + PTX as second-line therapy.
•- 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, during any first line therapy or within 4 months after the last dose of first-line therapy for metastatic or locally advanced disease.
•- Presence of primary or metastatic disease, measurable per RECIST v1.1 on CT scan.
•- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
•- Life expectancy of at least 3 months.
•- Age >= 18 years in the US and Japan, and >= 19 years of age in Korea.
•- Signed, written IRB-approved informed consent.
•- Adequate organ function from specimens collected within 14 days prior to Day 1.
•- For men and women of child-producing potential, the use of effective contraceptive methods during the study and for 6 months after the last dose of TRK-950.
•- All 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

•- Prior history of treatment with ramucirumab or paclitaxel.
•- HER2 positive gastric or GEJ adenocarcinoma.
•- Major surgery within 28 days prior to randomization.
•- Baseline corrected QT (QTc) interval of > 470 msec for females and > 450 msec for males calculated using Fridericia's formula.
•- New York Heart Association Class II - IV symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia.
•- The patient has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 3 months prior to randomization.
•- The patient has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
•- Clinically symptomatic venous thromboembolism or treatment with anti-coagulants.
•- Uncontrolled arterial hypertension >= 150 mmHg (systolic) or >= 90 mmHg (diastolic) despite standard medical management.
•- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
•- Pregnant or nursing women.
•- Treatment with radiation therapy within 2 weeks, or treatment with chemotherapy, immunotherapy, targeted therapy, or investigational therapy within 4 weeks prior to randomization (within 2 weeks for Oral FU (S1 and capecitabine)).
•- The patient has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to randomization.
•- Clinically significant ascites, paracentesis in the last 3 months, or undergoes regular paracentesis procedures.
•- History of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
•- The patient has a serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to randomization.
•- The patient has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (e.g., hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
•- Known active infection with HIV, hepatitis B or hepatitis C. 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 or discontinued within the last 28 days from 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 participating in surveys or observational studies are eligible to participate in this study.

研究者

发起方

Mori Yoshitaka

相似试验

进行中（未招募）

1 期

A Study in advanced squamous non small cell lung cancerStage IV Squamous Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 16.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2012-003214-13-DEEli Lilly and Company189

进行中（未招募）

不适用

A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung CancerDiseases of th respiratory system

KCT0001107Eli Lilly Korea15

进行中（未招募）

不适用

EUCTR2009-012280-34-CZJanssen-Cilag International N.V.164

已完成

2 期

A clinical trial to study the effects of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

CTRI/2009/091/000929Janssen Research Development LLC164

进行中（未招募）

1 期

A Randomized, Open-Label, Multicenter, Phase 2 Study of the Combination ofVELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone(VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, andPrednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal CenterB-Cell Subtype of Diffuse Large B-Cell Lymphomaon-Germinal Center B-Cell Subtype of Diffuse Large B-Cell LymphomaMedDRA version: 14.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2009-012280-34-BEJanssen-Cilag International N.V.164