Phase I Study of Surface-Controlled Water Soluble Curcumin (THERACURMIN CR-011L) in Patients With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Surface-Controlled Water Dispersible Curcumin
研究概览
简要总结
The goal of this clinical research study is to find the highest tolerable doses of surface-controlled water dispersible curcumin (curcumin) that can be given to patients with advanced cancer. The safety of this drug will also be studied.
详细描述
The Study Drugs:
Curcumin is the active ingredient in the spice, turmeric. It is a natural anti-inflammatory compound and has shown anti-tumor activity. Surface-controlled water dispersible curcumin is designed to be better absorbed by the body than regular curcumin.
Study Groups:
The first group of participants will receive the lowest dose level. Each new group will usually receive a higher dose than the group before it, if no intolerable side effects were seen. Each group will have 3-6 participants. This will continue until the highest tolerable dose of curcumin is found. Up to 6 dose levels of curcumin will be tested. Once the highest tolerable dose of each arm is found, up to 14 extra participants will be enrolled for extra safety testing.
In some cases, extra participants may be enrolled at dose levels shown to be safe for extra safety and/or pharmacokinetic (PK) and pharmacodynamic (PD) testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients must have an advanced malignancy that has either failed one or more prior therapies, or for which there is no established standard of care therapy that improves survival by at least 3 months. If standard therapies are available, the informed consent states that patients are forgoing approved therapies proven to prolong life or the time that the patient is alive without growth of their cancer.
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better (0-3).
- •Patients must have normal organ and marrow function as defined below: Absolute neutrophil count > 1,000 /uL Platelets > 50,000 /uL Total bilirubin </= 1.5 x upper limit of normal (ULN) (except patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL) and ALT </= 3 x ULN, Creatinine </= 1.5 x ULN or creatinine clearance >/= 40 ml/min
- •Patients must be able to understand and be willing to sign an Institutional Review Board (IRB) approved written informed consent document.
- •Women of child-bearing potential (women who are not postmenopausal for at least one year or are not surgically sterile) and men must agree to use adequate contraception (e.g., barrier device) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
- •Patients may receive palliative radiation therapy immediately before or during the treatment if the radiation therapy is not delivered to the sole target lesions.
- •Men and women aged >/= 18 years. However, patients who are 13 years or older will be eligible after consultation with their pediatric attending.
排除标准
- •Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, active bleeding that requires hospitalization, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Subject that has not recovered from major surgical procedure, open biopsy, or significant traumatic injury (i.e. subject still needs additional medical care for these issues).
- •History of gastric or duodenal ulcers, or hyperacidity syndromes.
- •History of allergic reactions to the study drug or its analogs.
- •Patient that has received any treatment for tumor specific control within 3 weeks of the start of study drug with investigational drugs and cytotoxic agents, or within 2 weeks of cytotoxic agent given weekly, or within 6 weeks of nitrosoureas or mitomycin C, or within 5 half-lives of biological targeted agents with half-lives and pharmacodynamic effects lasting less than 5 days (that includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents).
- •Currently taking therapeutic doses of anticoagulants such as warfarin or antiplatelet agents (any prophylaxis agents are acceptable).
- •International normalized ratio (INR) > 1.5
- •Biliary obstruction or cholelithiasis.
- •Inability to take oral medication (PEG tube is acceptable).
- •Pregnant or breastfeeding women.
- •Concurrent enrollment on another therapeutic research study.
研究组 & 干预措施
Surface-Controlled Water Soluble Curcumin Group
Starting dose 100 mg by mouth two times a day of a 28 day cycle.
干预措施: Surface-Controlled Water Soluble Curcumin (Drug)
Surface-Controlled Water Soluble Curcumin Expansion
Following finding of MTD surface-controlled water soluble curcumin, escalating dose levels
干预措施: Surface-Controlled Water Soluble Curcumin MTD (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Surface-Controlled Water Dispersible Curcumin
时间窗: 4 weeks
MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as treatment-related grade 3 or greater non-hematological toxicity other than nausea, vomiting, drug-related grade 3 or greater electrolyte abnormalities that do not return to ≤ grade 1 or baseline within 72 hours, or grade 3 nausea and vomiting related to study drug treatment that is not controlled at 72 hours despite appropriate antiemetic therapy. The defined events will be considered as DLT if they occur within the first cycle (28 days).
次要结局
未报告次要终点