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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
CS-7017 will be administered orally, twice daily for 28 days of each 28-day cycle in escalating doses depending on cohort patient is assigned to. Bexarotene will be administered orally once daily for 28 days of each 28-day cycle. The dose a patient receives will depend on which cohort the patient is assigned to.
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Maximum Tolerated Dose
The highest dose at which \< 1 out of 6 subjects experienced a dose-limiting toxicity
Time frame: 12 months
Response rate
Complete response + partial response
Time frame: 4 months
Disease control rate
Response rate + stable disease
Time frame: 4 months
Pharmacodynamic effects
PPAR-gamma and RXR analysis by immunohistochemistry; Tumor staining for the following PPAR-gamma regulated genes: Cyclin D1, p16, p18, p21, p27, and c-myc.
Time frame: Prior to treatment, Just prior to Day 1 and just prior to Day 15 of cycle 1
Pharmacokinetics
Trough serum levels of CS-7017 and its metabolites
Time frame: Day -7 prior to first dose of CS-7017, Day 1, and Day 15 of Cycle 1
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