An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Atiprimod
研究概览
简要总结
Primary Objectives:
The primary objectives of this study are to identify the maximum tolerated dose (MTD) and to evaluate the safety of atiprimod when given in doses starting at 60 mg/day and ranging to 360 mg/day, or the MTD, whichever is lower, in patients with advanced cancer.
Secondary Objectives:
The secondary objectives of this study are to measure the pharmacokinetics of atiprimod and to evaluate the efficacy of atiprimod treatment in patients with advanced cancer, and to compare the pharmacokinetics of atiprimod tablets and capsules at the starting dose, with the intent of switching to capsules for the dose escalation if the capsules pose no safety issues.
详细描述
Atiprimod was shown to slow or stop the growth of several human tumor cell lines in laboratory studies. Researchers believe it may have the same effect on tumor cells in patients with advanced cancer.
Before you can start treatment on the study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. At the screening visit, you will be asked questions about your medical history and any medications you use. You will be asked questions about your ability to carry out everyday activities (performance status). You will have a complete physical exam, including measurement of your vital signs (blood pressure, pulse, breathing rate, and temperature), routine blood (about 1 teaspoon) and urine tests, and an electrocardiogram (ECG--a test to measure the electrical activity of the heart).
You will have a neurological exam, which will include a series of questions and tasks (such as walking, talking, and touching your nose). The interview will take about 20 minutes to complete. Additionally, the study doctor will test your reflexes by tapping your arms, knees, and the bottom of your feet with a rubber triangle-shaped end of a special instrument that looks like a little hammer. The study doctor will also test your ability to sense light touch and pinprick, and will check your eyes with a special light source (ophthalmoscope). You will be asked questions about your physical, social/family, emotional, and functional well-being, as well as additional concerns you may have regarding numbness, tingling, discomforts, and difficulties you may be having. The interview will take about 10 minutes to complete.
The tumor will be measured by tests that are normally used to check the extent of disease in patients with the same type of cancer. This may include x-rays, MRIs, CT scans, or bone marrow biopsies. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must also have a negative pregnancy test in order to participate in this study.
If you complete all of the screening tests and are eligible to participate in the study, you will be scheduled to return to the clinic within 14 days, for baseline testing and the start of treatment (Day 1). You will be asked questions about your medical history and the medications you used since the last visit. You will have a physical exam, including measurement of your vital signs, and routine blood tests (about 1 teaspoon). A blood sample (roughly less than half of a teaspoon) will also be drawn for pharmacokinetic (PK) testing. PK testing is used to measure the amount of atiprimod in your blood. This first blood sample will be your "baseline" PK sample, and the drug level in later blood samples will be compared to it.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have histological proof of advanced cancer and must have failed or relapsed following standard therapy or have no standard therapy available.
- •Patient must have an estimated life expectancy of at least 12 weeks.
- •Patient must have measurable or evaluable disease.
- •Patient has an ECOG (Zubrod) performance status of 0 to
- •Age >/= 13 years at the time of signing informed consent.
- •All necessary screening evaluations for determining eligibility must be obtained within 14 days prior to the first dose of study drug except for measurement of disease extent, which can be obtained within 28 days prior to the first dose of study drug.
- •Patient must be able to adhere to the study visit schedule and other protocol requirements.
- •Patient must understand and voluntarily sign an informed consent document.
- •Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
排除标准
- •Renal insufficiency (serum creatinine levels >/= 2 times the upper limit of normal).
- •Concomitant radiotherapy, chemotherapy, or other investigational agents/therapies.
- •Peripheral neuropathy of Grade 3 or greater assessed by a directed neurologic examination, including light touch, pinprick, proprioception, and deep tendon reflexes of the upper and lower extremities; and questioning for symptoms of paresthesia and numbness (FACT/GOG-Ntx: Appendix D).
- •Patients with evidence of clinically significant mucosal or internal bleeding. (For example, a decrease in hemoglobin of greater than 1.5 gm will be considered clinically significant.)
- •Patients with a platelet count < 50,000 cells/mm^
- •Patients with an absolute neutrophil count (ANC) of < 1000 cells/mm^
- •ALT/SGPT or AST/SGOT levels >/= 2 times the upper limit of normal (ULN) except in patients with documented hepatic metastases.
- •Total bilirubin > 2 times the ULN.
- •Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study. Such examples include infection requiring hospitalization and psychiatric health which would make compliance understanding difficult.
- •Clinically relevant active infection or serious co-morbid medical conditions such as recent (</6 months) MI, unstable angina, difficult to control CHF, uncontrolled HTN, difficult to control cardiac arrhythmias, COPD or chronic restrictive pulmonary disease, and cirrhosis. Examples of uncontrolled HTN and difficult to control cardiac arrhythmias include situations in which patients still have the problem while on medication or patients who have required > two medication changes in the last 6 months in order to control the problem, or cardiac patients with a NYHA classification of > Class II.
- •If WCBP, pregnant, lactating, or not using adequate contraception.
- •As atiprimod is a potent inhibitor of CYP2D6 (a chemical that is produced naturally by the body that processes and eliminates certain types of chemicals), patients taking drugs that are substrates of CYP2D6 (e.g., beta blockers, antidepressants, and antipsychotics; see Appendix G) will be excluded from the study.
- •Received any form of radiotherapy, chemotherapy, or other investigational agents/therapies within 30 days prior to the first dose of study drug.
研究组 & 干预措施
Atiprimod
干预措施: Atiprimod (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Atiprimod
时间窗: With each 28 day (4 week) cycle
次要结局
未报告次要终点