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The purpose of this study is to determine (1) The side effects or toxicities of MLN8054;(2) The highest dose where side effects or toxicities are not too severe; (3) How MLN8054 is absorbed into the general blood circulation and eliminated from the body; and (4) The levels of MLN8054 in the blood that are needed to inhibit Aurora A kinase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MLN8054 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MLN8054 | Drug | MLN8054 will be administered orally in multiple divided daily doses for 7 days to 21 consecutive days. A 14-day recovery period will follow each dosing period, regardless of its duration. MLN8054 will be supplied in capsules of 5 mg or 25 mg with dose strength expressed as the milligrams of active drug (free acid). MLN8054 will be given on an empty stomach. Patients will be instructed to take nothing by mouth except for water and prescribed medications for 2 hours before and 1 hour after each dose. |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of MLN8054 will be based on the continuous monitoring and observation of patients and the collection and evaluation of adverse events and serious adverse events and the assessment of their potential relationship to the study medication. | 7 consecutive days of therapy with the option to increase to 14 or 21 days of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C518940 | MLN8054 |
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|
| D017437 |
| Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |