A Phase I Study of a Combination of the Proteosome Proliferator-Activated Receptor Gamma Agonist, CS-7017 and the Retinoid X Receptor Agonist, Bexarotene
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
This study is for patients with advanced solid tumors. The purpose of this study is to test the safety and effectiveness of a new combination of drugs, CS-7017 and Bexarotene in patients with advanced cancer. CS-7017 and Bexarotene both have many effects on cancer cells, including stopping cancer cells from growing and dividing, and causing the cancer cells to die. CS-7017 and Bexarotene work on cancer cells in a similar manner and both drugs together may have an even greater effect against cancer cells, hopefully, increasing the killing of cancer cells.
CS-7017 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in any type of cancer. Bexarotene is an anti-cancer agent that has been approved by the FDA for patients with a specific type of cancer, cutaneous T-cell lymphoma.
This study will help find out what effects the combination of drugs, CS-7017 and Bexarotene, has on cancer. This research is being done because it is not known if CS-7017 is safe to be given with Bexarotene.
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
- •Histologically proven advanced malignancy with measurable disease except for acute leukemias
- •Progression on, or intolerance of, or ineligibility for all standard therapies
- •Biopsy accessible tumor deposits
- •LVEF >/= institutional normal
- •No evidence of clinically significant fluid retention
- •ECOG Performance status 0-2
- •Subjects with no brain metastases or a history of previously treated brain metastases who have been treated with surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of intracranial disease and have not had treatment with steroids within one week of study enrollment.
- •Adequate hepatic, bone marrow, and renal function
- •Partial thromboplastin time must be </= 1.5 x upper limit of normal range and INR < 1.
- •Subjects on anticoagulant will be permitted to enroll as long as the INR is in the acceptable therapeutic range
- •Life expectancy > 12 weeks
- •Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- •Subject is capable of understanding and complying with parameters of the protocol and able to sign and date the informed consent.
排除标准
- •Prior CS-7017 treatment
- •Treatment with thiazolidinediones (TZDs) within 4 weeks prior to start of study treatment
- •Current need for concomitant use of other TZDs during the study
- •Grade 2 or greater fasting hypertriglyceridemia
- •Concurrent use of insulin
- •Concurrent use of known CYP 3A4 inhibiting or activating medications
- •CNS metastases which do not meet the criteria outlines in inclusion criteria
- •Active severe infection or known chronic infection with HIV or hepatitis B virus
- •Cardiovascular disease including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke or congestive heart failure within the last 6 months
- •Life-threatening visceral disease or other severe concurrent disease
- •Women who are pregnant or breastfeeding
- •Anticipated survival under 3 months
- •Clinically significant and uncontrolled major medical condition(s)
研究组 & 干预措施
CS-7017 and Bexarotene
Combination of CS-7017 and Bexarotene
干预措施: CS-7017 and Bexarotene (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 12 months
The highest dose at which \< 1 out of 6 subjects experienced a dose-limiting toxicity
次要结局
- Response rate(4 months)
- Disease control rate(4 months)
- Pharmacodynamic effects(Prior to treatment, Just prior to Day 1 and just prior to Day 15 of cycle 1)
- Pharmacokinetics(Day -7 prior to first dose of CS-7017, Day 1, and Day 15 of Cycle 1)