NCT02241720终止2 期
Regorafenib as a Second Line Single Agent in the Treatment of Metastatic or Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants With Stable Disease at Eight Weeks Post-Treatment
研究概览
简要总结
Regorafenib as a Second Line Single Agent in the Treatment of Metastatic or Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of metastatic or locally advanced inoperable adenocarcinoma of the esophagus, gastroesophageal junction or stomach.
- •Patients must show signs of progression during or less than 4 months after being treated with a first line therapy for their metastatic or locally advanced inoperable cancer.
- •Patients must have measureable disease at screening by Response Evaluation Criteria for Solid Tumors 1.1 criteria
- •Age greater than or equal to 18 years.
- •Eastern Cooperative Oncology Group Performance Status 0-1
- •Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
- •All acute toxic effects of any prior treatment have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 Grade 1 or less at the time of signing the Informed Consent Form. Alopecia (any grade) and peripheral neuropathy less than grade 2 is allowed.
- •Adequate bone marrow, liver and liver function as assessed by laboratory requirement
- •Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
- •Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form until at least 3 months after the last dose of study drug. Highly effective contraception must be used (male condom with spermicidal, diaphragm with spermicidal, intra-uterine device) by both sexes.
- •Subject must be able to swallow and retain oral medication.
排除标准
- •Prior use of regorafenib
- •Uncontrolled hypertension (systolic pressure greater than 140 mm Hg or diastolic pressure greater than 90 mm Hg National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 on repeated measurement) despite optimal medical management.
- •Active or clinically significant cardiac disease including:
- •Congestive heart failure - New York Heart Association greater than Class
- •Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers.
- •Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
- •Evidence or history of bleeding diathesis or coagulopathy.
- •Any hemorrhage or bleeding event greater than or equal to National Cancer Institute Common Terminology Criteria for Adverse Events Grade 3 within 4 weeks prior to start of study medication.
- •Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment
- •Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed. All cancer treatments must be completed at least 3 years prior to start of study treatment.
- •Patients with severe hepatic impairment (Child-Pugh Class C)
- •Known history of human immunodeficiency virus infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
- •Patients requiring intravenous antiviral or intravenous antibiotic treatment for ongoing infections
- •Symptomatic metastatic brain or meningeal tumors.
- •Presence of a non-healing wound, non-healing skin ulcer, or bone fracture.
- •Patient's with a history of kidney disease or persistent proteinuria must have less than Grade 3 proteinuria per NCI CTCAE v4.0 at screening. If a patient has a history of kidney disease or persistent proteinuria, a urine protein test will be performed on a random urine sample. If the result is normal then no additional testing is required. If the result is abnormal, a 24 hour urine will be collected to determine if proteinuria is less than Grade
- •Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
- •Pleural effusion or ascites that causes respiratory compromise (greater than or equal to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 Grade 2 dyspnea). Patients may undergo thoracentesis and paracentesis to improve symptoms prior to enrollment.
- •History of organ allograft (including corneal transplant).
- •Known or suspected grade 3 allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial.
- •Any malabsorption condition that in the opinion of the investigator would significantly impact drug absorption.
- •Women who are pregnant or breast-feeding.
- •Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
- •Substance abuse, medical, psychological or social conditions that in the opinion of the investigator may interfere with the subject's participation in the study or evaluation of the study results.
- •Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) within 28 days of starting study treatment. Palliative radiation is allowed.
- •Concurrent use of another investigational drug or device during, or within 3 weeks of starting study treatment.
- •Concurrent use of strong CYP3A4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort)
- •Concurrent use with strong inhibitors of CYP3A4 (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazadone, posaconazole, telithromycin, and voriconazole)
- •Major surgical procedure, open biopsy, or significant traumatic injury within 3 weeks before start of study medication.
研究组 & 干预措施
Regorafenib treatment
Experimental
干预措施: regorafenib (Drug)
结局指标
主要结局
Number of Participants With Stable Disease at Eight Weeks Post-Treatment
时间窗: 5 months - 3 months treatment and 8 weeks post end of treatment visit
Patients had disease assessed by CT scans. Stable Disease is defined by any response better than Progression as defined by RECIST 1.1. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Regorafenib monotherapy as second-line treatment of patients with RAS-mutant advanced colorectal cancer: a multicentre, single-arm, two-stage, phase 2 study.patients with RAS-mutant advanced colorectal cancerMedDRA version: 21.0Level: LLTClassification code 10038029Term: Rectal adenocarcinoma stage IVSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10001172Term: Adenocarcinoma of colon stage IVSystem Organ Class: 100000004864EUCTR2015-001105-13-ITISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE46
终止
2 期
Regorafenib as Single Agent in Patients With Metastatic Colorectal Cancer (mCRC) With Any RAS or BRAF Mutation Previously Treated With FOLFOXIRI Plus BevacizumabMetastatic DiseaseColorectal NeoplasmsNCT02175654Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)15
已完成
2 期
Regorafenib in Treating Patients With Advanced or Metastatic Neuroendocrine TumorsGastrinomaMetastatic Gastrointestinal Carcinoid TumorPulmonary Carcinoid TumorRecurrent Gastrointestinal Carcinoid TumorRecurrent Islet Cell CarcinomaSomatostatinomaPancreatic Polypeptide TumorInsulinomaGlucagonomaNCT02259725University of Southern California3
进行中（未招募）
2 期
Regorafenib Monotherapy as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal CancerAdvanced Colorectal CancerNCT02619435National Cancer Institute, Naples46
已完成
2 期
A Study Using Regorafenib as Second or Third Line Therapy in Metastatic Medullary Thyroid CancerThyroid CancerNCT02657551Dana-Farber Cancer Institute17