NCT00765466终止2 期
A Phase II Open Label, Multi-Center Study With AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Karnofsky Performance Status Disease-related symptoms: ESAS and PG-SGA Anorexia Weight Lean Body Mass, Triceps skin fold, and grip strength
研究概览
简要总结
This is an open label, Phase II, multi-center study designed to evaluate the effect of AVR118 when administered to patients with systemic symptoms related to recurrent or metastatic cancers who may or may not be undergoing anti-cancer treatment. During the initial, induction treatment phase of the study, AVR118, 4.0 mL, will be given subcutaneously each day for 28 days. Patients who respond to the trial period dosing will be eligible to continue on AVR118 if they and their physicians believe it would be beneficial, and if no safety concerns are raised.
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
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed solid tumor cancer, leukemia, lymphoma, or multiple myeloma.
- •Concurrent anti-cancer treatment, such as chemotherapy or radiation therapy is permitted except for neo-adjuvant or adjuvant programs.
- •Between the ages of 18-
- •Symptoms of recurrent or metastatic cancer in which anorexia is a predominant symptom, not necessarily associated with cachexia, and are not attributed to anemia, concomitant illnesses, or obstruction or loss of organ function.
- •Karnofsky performance status of 40%
- •Palliative Prognostic Score (PaP) of less than 6
- •Patient is expected to be able to remain on a study protocol for two months.
- •Pretreatment laboratory data within 7 days of enrollment:
- •Hemoglobin >8.5 g/dL , or on stable doses (hematocrit stable within 1 gram and dose stable for one month) of erythropoietin or similar medication.
- •Absolute neutrophil count (ANC) 1,500/mm
- •Platelets 50,000/mm
- •Total bilirubin 2.0
- •ALT and AST 2.5 times the ULN, or, if the patient has liver metastases, 5 times the ULN.
- •Creatinine 1.5 mg/dL.
- •Normal TSH
- •Testosterone levels determined.
- •Voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care.
- •Ability to self-administer subcutaneous medication if an assistant or nurse is not available, and to keep a compliance journal documenting injections at home.
- •If on an antidepressant, the dose must have been stabilized for at least 30 days.
- •Female patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of the study.
- •Male patient agrees to use an acceptable barrier method for contraception during the study
排除标准
- •Patient has uncontrolled brain metastases or central nervous system disease.
- •Patient has mechanical, non-reversible reason for not being able to eat, or have a potential for developing malignant bowel obstruction during the course of the induction phase of treatment, or patients requiring a PEG for obstruction.
- •Patient has had any major surgery within four weeks of enrollment.
- •Patient has an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- •In the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- •Female patient is pregnant or breast-feeding.
结局指标
主要结局
Karnofsky Performance Status Disease-related symptoms: ESAS and PG-SGA Anorexia Weight Lean Body Mass, Triceps skin fold, and grip strength
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
Palliative Care Study in Patients With Advanced CancerCancerNCT00127517Advanced Viral Research Corp
进行中（未招募）
2 期
A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell LymphomaMantle Cell Lymphoma (MCL)NCT05951959AstraZeneca108
已完成
2 期
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C InfectionHepatitis C, ChronicNCT02765490Janssen Research & Development, LLC365
终止
2 期
Study of AVE1642 (IGF-1R/CD221) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast CancerBreast NeoplasmsNCT00774878Sanofi18
终止
2 期
Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)IgA NephropathyIgANNCT05125068Eledon Pharmaceuticals24