JPRN-jRCTs031190096已完成2 期
A multicenter, phase 2 study to evaluate safety and efficacy of panitumumab re-challenge based on circulating tumor DNA analysis in patients with RAS/BRAF V600E wild-type unresectable metastatic colorectal cancer with prior treatment history of anti-EGFR antibody - PURSUIT
Ohta Takashi0 个研究点目标入组 50 人开始时间: 2019年10月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
The efficacy of panitumumab + irinotecan therapy as an anti-EGFR antibody rechallenge was insufficient for colorectal cancer patients who were determined to be negative for blood RAS mutations by ctDNA analysis. In the future, it was considered necessary to examine effect predictors to increase efficacy.
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)Histological diagnosis of primary colorectal adenocarcinoma.
- •2)RAS(KRAS/NRAS)and BRAF V600E wild type analyzed by tumor tissue.
- •3)Intolerant or refractory to chemotherapy including a fluoropyrimidine, oxaliplatin and irinotecan.
- •4)Complete or partial response to previous chemotherapy including anti-EGFR antibody (cetuximab or panitumumab).
- •5)Documentation of progression to previous anti-EGFR antibody within 2 months after last anti-EGFR antibody administration.
- •6)Negative for plasma RAS mutant within 28 days before registration.
- •7)Time between the end of previous anti-EGFR antibody and the start of protocol treatment with panitumumab plus irinotecan >= 4 months.
- •8)Measurable disease according to RECIST guideline v1.1.
- •9)ECOG 0 or 1.
- •10)Age >= 20 year old.
- •11)Adequate major organ function assessed within 14 days before registration.
- •12)Life expectancy of at least 12 weeks.
- •13)Written informed consent obtained.
排除标准
- •1)Severe comorbidity.
- •2)Underwent one of following treatments before protocol treatment;
- •a. Extensive surgery within 4 weeks.
- •b. Colostomy/ileostomy within 2 weeks.
- •c. Chemotherapy within 2 weeks.
- •d. Radiation therapy within 2 weeks.
- •3)CTCAE Grade >= 2 adverse events due to previous therapy, which are not recovered.
- •4)History of severe infusion reactions to anti-EGFR antibody.
- •5)Intolerant to previous irinotecan therapy.
- •6)Comorbidity or history of severe pulmonary disease.
- •7)Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test.
- •8)Active HCV or HIV infection.
- •9)Any other patients who are regarded as inadequate for study enrollment by investigators.
研究者
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