EUCTR2014-000804-88-IT进行中（未招募）不适用
A Phase 2 Trial of MLN0264 in Previously Treated Patients With Metastatic or Recurrent Adenocarcinoma of the Stomach or Gastroesophageal Junction Expressing Guanylyl Cyclase C (GCC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 81
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each patient must meet all the following inclusion criteria to be enrolled in the study:
- •1. Male or female patients 18 years of age or older when written informed consent is obtained.
- •2. Histologically confirmed metastatic or advanced inoperable adenocarcinoma of the stomach or gastroesophageal junction with IHC evidence of GCC expression indicated by an H-score of 10 or greater.
- •3. Treatment with 1 or more prior chemotherapies for advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.
- •4. Measurable disease as defined by RECIST version 1.1 guidelines.
- •5. ECOG performance status of 0 or 1 within 14 days before enrollment.
- •6. Female patients who:
- •- Are postmenopausal for at least 1 year before the screening visit, OR
- •- Are surgically sterile, OR
- •- If they are of childbearing potential, agree to practice 2 effective methods ofcontraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or
- •- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)
- •Male patients, even if surgically sterilized (ie, status postvasectomy), who:
- •- Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or
- •- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
- •7. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- •8. Adequate organ and hematological function as evidenced by the following laboratory values within 14 days before enrollment:
- •- Absolute neutrophil count (ANC) = 1.5 x109/L
- •- Platelet count = 100 x 109/L
- •- Hemoglobin = 9 g/dL
- •- Activated partial thromboplastin time (aPTT) = 1.5 x the upper limit of the normal range (ULN) per institutional laboratory normal range
- •- International normalized ratio (INR) = 1.5 x ULN
- •- Serum creatinine = 1.5 x ULN
- •- Total bilirubin = 1.5 x ULN
- •- Albumin = 3g/dL
- •- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN
- •- Serum lipase = 3 x ULN and serum amylase within the normal range
- •9. Resolution of all toxic effects of prior treatments except alopecia to Grade 0 or 1 by NCI CTCAE version 4.03.
- •10. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- •1. Radiotherapy within 4 weeks before enrollment
- •2. Concurrent treatment or treatment within 4 weeks of study entry with any other investigational agent or chemotherapy
- •3. Female patients who are lactating and breastfeeding or have a positive pregnancy test during the Screening period
- •4. Uncontrolled, clinically significant, symptomatic cardiovascular disease within 6 months before enrollment, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient
- •5. 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 before starting study drug
- •6. Patients with ECG abnormalities considered by the investigator to be clinically significant, or repeated baseline prolongation of the rate-corrected QT interval (QTc)
- •7. Ongoing or clinically significant active infection as judged by the investigator
- •8. Signs of PN = NCI CTCAE Grade 2
- •9. Concomitant chemotherapy, hormonal therapy, immunotherapy, or any other form of cancer treatment
- •10. Use of strong cytochrome P450 (CYP) 3A4 inhibitors within 2 weeks before the first dose of study drug
- •11. Any preexisting medical condition of sufficient severity to prevent full compliance with the study
- •12. History of or current neoplasm other than gastric adenocarcinoma, except for curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix uteri
- •13. Known diagnosis of human immunodeficiency virus (HIV) infection
- •14. Symptomatic brain metastases
- •15. Ongoing anticoagulant therapy (eg, aspirin, coumadin, heparin)
研究者
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