Phase I Study of CS-7017 and Bexarotene
| Status: | Terminated |
|---|---|
| Conditions: | Cancer, Blood Cancer, Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/15/2017 |
| Start Date: | December 2011 |
| End Date: | December 2016 |
A Phase I Study of a Combination of the Proteosome Proliferator-Activated Receptor Gamma Agonist, CS-7017 and the Retinoid X Receptor Agonist, Bexarotene
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.
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.
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. 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)
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