Phase I Study of CS-7017 and Bexarotene
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|ClinicalTrials.gov Identifier: NCT01504490|
Recruitment Status : Terminated (Drug no longer available)
First Posted : January 5, 2012
Last Update Posted : February 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors Lymphoma Multiple Myeloma||Drug: CS-7017 and Bexarotene||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
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.
- Maximum Tolerated Dose [ Time Frame: 12 months ]The highest dose at which < 1 out of 6 subjects experienced a dose-limiting toxicity
- Response rate [ Time Frame: 4 months ]Complete response + partial response
- Disease control rate [ Time Frame: 4 months ]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 ]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 ]Trough serum levels of CS-7017 and its metabolites
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|