Phase I Study of CS-7017 and Bexarotene

NCT ID: NCT01504490

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2016-12-31

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 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.

Conditions

Solid Tumors; Lymphoma; Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CS-7017 and Bexarotene

Combination of CS-7017 and Bexarotene

Group Type: EXPERIMENTAL

CS-7017 and Bexarotene

Intervention Type: DRUG

CS-7017 will be administered orally, twice daily for 28 days of each 28-day cycle in escalating doses depending on cohort patient is assigned to.

Bexarotene will be administered orally once daily for 28 days of each 28-day cycle. The dose a patient receives will depend on which cohort the patient is assigned to.

Interventions

CS-7017 and Bexarotene

CS-7017 will be administered orally, twice daily for 28 days of each 28-day cycle in escalating doses depending on cohort patient is assigned to.

Bexarotene will be administered orally once daily for 28 days of each 28-day cycle. The dose a patient receives will depend on which cohort the patient is assigned to.

Intervention Type: DRUG

Other Intervention Names

Efatutazone; Targretin

Eligibility 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.

• 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)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Pishvaian, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

2011-345

Identifier Type: -

Identifier Source: org_study_id