Phase I Study of CS-7017 and Bexarotene

Georgetown University

Status and phase

Terminated

Phase 1

Conditions

Multiple Myeloma

Lymphoma

Solid Tumors

Treatments

Drug: CS-7017 and Bexarotene

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01504490

2011-345

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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.

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)