Phase I Study of CS-7017 and Bexarotene

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborators: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Bexarotene; Efatutazone

Criteria

Inclusion Criteria:

• 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 be1.5. 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.

Exclusion Criteria:

• 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)