Phase I Study of CS-7017 and Bexarotene
Information source: Georgetown University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Solid Tumors; Lymphoma; Multiple Myeloma
Intervention: CS-7017 and Bexarotene (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Georgetown University Official(s) and/or principal investigator(s): Michael Pishvaian, MD PhD, Principal Investigator, Affiliation: Georgetown University
Overall contact: Ion Cotarla, Phone: 202-687-4510, Email: ic34@georgetown.edu
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.
Clinical Details
Official title: A Phase I Study of a Combination of the Proteosome Proliferator-Activated Receptor Gamma Agonist, CS-7017 and the Retinoid X Receptor Agonist, Bexarotene
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maximum Tolerated Dose
Secondary outcome: Response rateDisease control rate Pharmacodynamic effects Pharmacokinetics
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 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)
Locations and Contacts
Ion Cotarla, Phone: 202-687-4510, Email: ic34@georgetown.edu
Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia 20007, United States; Recruiting Ion Cotarla, Phone: 202-687-4510, Email: ic34@georgetown.edu Christine Fasano, RN, Phone: 202-687-2007, Email: ccf42@georgetown.edu Michael Pishvaian, MD PhD, Principal Investigator
Additional Information
Starting date: December 2011
Last updated: February 13, 2015
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