Phase 1/2 Trial of MLN0264 in Previously Treated Asian Patients With Advanced Gastrointestinal (GI) Carcinoma (Phase 1) or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma (Phase 2) Expressing Guanylyl Cyclase C (GCC)

TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 95 人开始时间: 2015年3月19日最近更新: 2023年10月17日

适应症

试验速览

阶段: 1 期
发起方
入组人数: 95

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

•Has Diagnosis of GI carcinoma with IHC evidence of expression of GCC protein (Hscore of 10 or greater), for which standard treatment is no longer effective or does not offer curative or life-prolonging potential
•- Has completed prior chemotherapy, immunotherapy or radiation therapy at least4 weeks prior to enrollment (except for Avastin [bevacizumab] for which at least 8 weeks from its last administration should elapse prior to enrollment)
•- Histologically confirmed metastatic or advanced inoperable adenocarcinoma of the stomach or gastroesophageal junction with IHC evidence of expression of GCC indicated by an H-score of 10 or greater
•- Has completed prior chemotherapy, immunotherapy or radiation therapy at least 4 weeks prior to enrollment
•- Has measurable disease as defined by RECIST version 1.1 guidelines
•- Has Eastern Cooperative Oncology Group performance status of 0 or 1 (within 14 days prior to enrolment)
•- Females must be 1-year postmenopausal, or even if surgically sterile, agree to use other acceptable forms of birth control
•- Has adequate organ and hematological function
•- Has resolution of all toxic effects of prior treatments except alopecia to Grade 0 or 1 by NCI CTCAE version 4.03

排除标准

•- Has resolution of all toxic effects of prior treatments except alopecia to Grade 0 or 1 by NCI CTCAE version 4.03
•- Has Concurrent treatment or treatment within 4 weeks of study entry with any other investigational agent
•- Female patients who are in the lactation period, even if they discontinue breastfeeding, or have a positive pregnancy test during the Screening period
•- Has uncontrolled, clinically significant, symptomatic cardiovascular disease within 6 months prior to enrollment
•- Has treatment with any medication that has a clinically relevant potential risk of prolonging the QT interval or inducing torsades de pointes that cannot be discontinued or switched to a different medication prior to starting study drug
•- Participants with ECG abnormalities considered by the investigator to be clinically -significant, or repeated baseline prolongation of the rate-corrected QT interval (millisec) of electrocardiograph the (QTc)
•- Ongoing or clinically significant active infection
•- Has signs of peripheral neuropathy
•- Concomitant chemotherapy, hormonal therapy, immunotherapy, or any other form of cancer treatment
•- Use of strong cytochrome P450 (CYP) 3A4 inhibitors within 2 weeks before the first dose of study drug
•- Has any preexisting medical condition of sufficient severity to prevent full compliance with the study
•- Has past or concurrent history of neoplasm other than GI carcinoma (phase 1) or gastric adenocarcinoma (phase 2), except for curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix uteri
•- Known diagnosis of human immunodeficiency virus (HIV) infection
•- Has asymptomatic brain metastases
•- Has an alcohol or substance abuse disorder
•- Has positive test for hepatitis B surface antigen
•- History of hypersensitivity to any ingredient of MLN0264

研究者

发起方

TAKEDA PHARMACEUTICAL COMPANY LTD.

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