Phase I Study of CS-7017 and Bexarotene
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.
Drug: CS-7017 and Bexarotene
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of a Combination of the Proteosome Proliferator-Activated Receptor Gamma Agonist, CS-7017 and the Retinoid X Receptor Agonist, Bexarotene|
- Maximum Tolerated Dose [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]The highest dose at which < 1 out of 6 subjects experienced a dose-limiting toxicity
- Response rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]Complete response + partial response
- Disease control rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]Response rate + stable disease
- Pharmacodynamic effects [ Time Frame: Prior to treatment, Just prior to Day 1 and just prior to Day 15 of cycle 1 ] [ Designated as safety issue: No ]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.
- Pharmacokinetics [ Time Frame: Day -7 prior to first dose of CS-7017, Day 1, and Day 15 of Cycle 1 ] [ Designated as safety issue: No ]Trough serum levels of CS-7017 and its metabolites
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: CS-7017 and Bexarotene
Combination of CS-7017 and Bexarotene
Drug: CS-7017 and Bexarotene
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504490
|United States, District of Columbia|
|Georgetown Lombardi Comprehensive Cancer Center|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Michael Pishvaian, MD PhD||Georgetown University|