EUCTR2010-020325-40-FR进行中（未招募）1 期
Phase Ib/II, Multicenter, Open-Label, Randomized, Clinical Study with DoseOptimization of Two Different Schedules of Elisidepsin Trifluoroacetate(Irvalec®) as a Single Agent in Patients with Unresectable, Locally Advanced orMetastatic Esophageal, Esophagogastric Junction or Gastric Cancer AfterFailure of One but not More than Two Prior Lines of Systemic Therapy - IMAGE
Pharma Mar, S.A. Sociedad Unipersonal0 个研究点目标入组 126 人开始时间: 2010年7月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
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
- •1. Age = 18 years.
- •2. Eastern Cooperative Oncology Group (ECOG) PS of = 1 (see Appendix 1).
- •3. Life expectancy = 3 months.
- •4. Patients with histologically/cytologically confirmed diagnosis of locally advanced
- •(unresectable) or metastatic esophageal, esophagogastric junction or gastric cancer.
- •Patients must have received one but not more than two prior lines of systemic
- •therapy and must be progressing after last prior therapy before study entry.
- •5. Adequate bone marrow, renal, hepatic, and metabolic function (assessed = 7 days
- •before first study drug administration):
- •a) Platelet count = 100 x 109/l, hemoglobin = 8.5 g/dl and absolute neutrophil count (ANC) = 1.0 x 109/l.
- •b) Aspartate aminotransferase (AST) and ALT = 3.0 x upper limit of normal (ULN), independently of the presence of liver metastases.
- •c) Direct bilirubin = ULN and total bilirubin = 1.5 x ULN.
- •d) International Normalized Ratio (INR) = 1.5 (except if ongoing oral anticoagulation therapy).
- •e) Renal function: patients with calculated creatinine clearance (using Cockcroft
- •and Gault’s formula, see Appendix 3) = 30 ml/min.
- •f) Albumin = 2.5 g/dl.
- •6. Recovery to grade = 1 from any AE derived from any previous anticancer treatment
- •(excluding alopecia and grade 2 non-painful peripheral neuropathy).
- •7. Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six months after
- •discontinuation of treatment. Acceptable methods of contraception include
- •complete abstinence, intrauterine device (IUD), oral contraceptive, subdermal
- •implant and double barrier (condom with a contraceptive sponge or contraceptive
- •suppository).
- •8. Voluntarily signed and dated written informed consent, obtained from the patient
- •prior to any specific study procedure.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Concomitant diseases/conditions:
- •a) Clinically relevant non-neoplastic liver disease [i.e., cirrhosis; active chronic
- •hepatitis, hepatitis C virus (HCV)/hepatitis B virus (HBV) infection].
- •b) History or presence of unstable angina, myocardial infarction, clinically relevant valvular heart disease, treatment-requiring and/or symptomatic arrhythmia or congestive heart failure within the last six months prior to enrollment.
- •c) Active uncontrolled infection.
- •d) Known human immunodeficiency virus infection (HIV1/2).
- •e) Limitation of the patient’s ability to comply with the treatment or follow-up protocol.
- •f) Parenteral nutritional support = 25% of total daily caloric requirements.
- •g) Any other major illness that, in the Investigator’s or the Sponsor’s judgment, will substantially increase the risk associated with the patient’s participation in this study.
- •h) Painful peripheral neuropathy = grade 2.
- •i) Any ongoing cancer-related coagulopathy disorder [other than medically treated deep venous thrombosis (DVT) during at least one month].
- •2. Known central nervous system (CNS) metastatic involvement.
- •3. Malignant or non-malignant ascitis = grade 3.
- •4. Primary histology other than squamous-cell carcinoma or adenocarcinoma.
- •5. Prior treatment with elisidepsin or KF.
- •6. Less than 50 kg of body weight (only for patients included in the dose optimization
- •7. Men or women of childbearing potential who are not using an effective method of
- •contraception as previously described; women who are pregnant or breast feeding.
- •8. High transfusional requirements (> 4 packages of red blood cells and/or one platelet transfusion) in the last four weeks prior to study entry.
- •9. Participation in another clinical trial or concomitant treatment with any investigational product in the 4-week period prior to study entry.
- •10. Patients with a prior invasive malignancy (except non-melanoma skin cancer) who
- •have had any evidence of disease within the last three years.
- •11. Major surgery performed or planned within four weeks of the start of study treatment (line placement is not considered major surgery).
- •12. Patients with serious non-healing wound or ulcer. This includes history of abdominal fistula, gastrointestinal perforation, active uncontrolled bleeding or intraabdominal abscess during the last three months before study entry.
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