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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 rate

Disease 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. 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

Page last updated: August 23, 2015

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