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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS-7017 and Bexarotene | Experimental | Combination of CS-7017 and Bexarotene |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | The highest dose at which < 1 out of 6 subjects experienced a dose-limiting toxicity | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Complete response + partial response | 4 months |
| Disease control rate | Response rate + stable disease | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Pishvaian, MD PhD | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C510342 | efatutazone |
| D000077610 | Bexarotene |
| ID | Term |
|---|---|
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Pharmacodynamic effects | PPAR-gamma and RXR analysis by immunohistochemistry; Tumor staining for the following PPAR-gamma regulated genes: Cyclin D1, p16, p18, p21, p27, and c-myc. | Prior to treatment, Just prior to Day 1 and just prior to Day 15 of cycle 1 |
| Pharmacokinetics | Trough serum levels of CS-7017 and its metabolites | Day -7 prior to first dose of CS-7017, Day 1, and Day 15 of Cycle 1 |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |