Phase I Study of CS-7017 and Bexarotene

NCT01504490 | Terminated Phase 1 DMC

• 1 other identifier: 2011-345
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Keywords

Advanced cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  The highest dose at which \< 1 out of 6 subjects experienced a dose-limiting toxicity

  12 months

Secondary Outcomes (4)

• Response rate

  4 months

• Disease control rate

  4 months

• Pharmacodynamic effects

  Prior to treatment, Just prior to Day 1 and just prior to Day 15 of cycle 1

• Pharmacokinetics

  Day -7 prior to first dose of CS-7017, Day 1, and Day 15 of Cycle 1

Study Arms (1)

CS-7017 and Bexarotene

EXPERIMENTAL

Combination of CS-7017 and Bexarotene

Drug: CS-7017 and Bexarotene

Interventions

CS-7017 and Bexarotene 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.

Also known as: Efatutazone, Targretin

CS-7017 and Bexarotene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Georgetown University: lead
• Daiichi Sankyo: collaborator

Study Sites (1)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Lymphoma; Multiple Myeloma

Interventions

efatutazone; Bexarotene

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Michael Pishvaian, MD PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: January 5, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 14, 2017

Record last verified: 2017-02

Locations

US (1)