JPRN-jRCTs041220070招募中2 期
A phase II basket study of necitumumab for EGFR amplification positive m etastatic solid tumor: WJOG15021M
Kodera Yasuhiro0 个研究点目标入组 22 人开始时间: 2022年10月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 22
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Written consent has been obtained from the pat ient after sufficient explanation of the study contents prior to enrollment in the study.
- •2)Written consent has been obtained from the patient for the collection of blood for ctDNA analysis after sufficient explanation has been given.
- •3)The patient's age is 20 years or older at the time of obtaining consent.
- •4)Histologically or cytologically diagnosed with es ophageal, gastric, small intestinal, urothelial, or breast cancer.
- •5)Diagnosed as EGFR gene amplification positive by FoundationOne CDx or NCC Oncopanel Syste musing tumor specimens, or by FoundationOne Liquid CDx or Guardant360 using blood specimens.
- •6)No genetic abnormalities in EGFR(excluding am plification),RAS,BRAF,MAP2K,or ERBB2.
- •7)Unresectable advanced or recurrent esophagea l, gastric, small intestinal, urothelial, or breast cancer.
- •8)No metastasis to the symptomatic central nervo us system (brain,spinal cord,or meninges).
- •9)Has measurable lesion according to RECIST guidelines version 1.1
- •10)Refractory or intolerant to standard chemotherapy.
- •Esophageal, small bowel, and urothelial cancer: refractory/intolerant to at least 1 regimen.
- •Gastric cancer: refractory/intolerant to at least 2 regimens
- •Hormone receptor negative breast cancer: Prior anthracycline and taxane therapy
- •Hormone receptor positive breast cancer: refractory to hormone therapy and prior anthracycline and taxane therapy
- •11)ECOG Performance Status of 0 or 1
- •12)Expected to survive for at least 3 months
- •13)Latest laboratory values within 7 days prior to enrollment
- •(1)Neutrophil count >=1,500/mm3
- •(2)Hemoglobin >= 8.0 g/dL
- •(3)Platelet count >= 100,000/mm3
- •(4)Total bilirubin <= 1.5 mg/dL
- •(5)AST (GOT) <= 100 IU/L (<= 200 IU/L if liver metastasis is present)
- •(6)ALT (GPT) <=100 IU/L (<= 200 IU/L for patient s with liver metastases)
- •(7)Serum creatinine <= 1.5 mg/dL, but serum cre atinine >1.5 mg/dL is also eligible if creatinine clearance (CCr) >= 40 mL/min is met.
排除标准
- •1)Has active multiple cancers
- •2)Has a local infection or systemic active infection that requires treatment
- •3)Clinically problematic psychiatric disorders that would make enrollment in the study difficult
- •4) The patient has the following complications
- •(1)Renal failure
- •(2)Liver failure
- •(3)Interstitial pneumonia/pulmonary fibrosis
- •(4)Unstable angina pectoris
- •(5)Other complications that the physician in charg e judges to be serious
- •5)Known to be HER2 positive
- •Gastric cancer, breast cancer: HER2 test required (only HER2 negative patients are eligible) Esophageal cancer, small intestine cancer, urothelial cancer: Not ineligible even if HER2 test is not performed.
- •6)History of treatment with EGFR inhibitors
- •7)History of severe hypersensitivity
- •8)Received any of the following treatments within the specified time period prior to enrollment in this study
- •(1)Prior therapy (chemotherapy, molecular target ed therapy, antibody therapy, hormone therapy, immunotherapy, radiation therapy) within 2 weeks prior to enrollment
- •(2)Underwent major surgery (minor surgery such as lymph node biopsy, needle biopsy, or portimpl antation is not applicable) within 2 weeks prior to enrollment.
- •9) Pregnant women, lactating women, women who may be currently pregnant, or men and women who do not intend to use contraception.
- •10) Other cases deemed inappropriate by the physician in charge.
研究者
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