Status:
TERMINATED
Phase I Study of CS-7017 and Bexarotene
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Solid Tumors
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01504490
Start Date
December 1 2011
End Date
December 1 2016
Last Update
February 14 2017
Active Locations (1)
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1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007