Phase I Study of CS-7017 and Bexarotene

Stopped early · Phase 1

Conditions studied: Solid Tumors, Lymphoma, Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT01504490

Run by

Georgetown University

People needed

9

Starts

2011-12-01

Expected to finish

2016-12-01

Last updated by the study team

2017-02-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 < 1.5. 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.

You may not qualify if…

• 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)

Where it is running

• Georgetown Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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