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Sponsored by: |
Millennium Pharmaceuticals, Inc. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00249301 |
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.
Condition | Intervention | Phase |
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Breast Neoplasm Colon Neoplasm Pancreatic Neoplasm Bladder Neoplasm |
Drug: MLN8054 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | An Open-Label, Dose Escalation Phase 1 Study of MLN8054, a Novel Aurora A Kinase Inhibitor, in Patients With Advanced Solid Tumors |
Enrollment: | 63 |
Study Start Date: | October 2005 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
MLN8054
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Drug: MLN8054
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Millennium Pharmaceuticals, Inc. ( Clinical Study Medical Monitor ) |
Study ID Numbers: | C10001 |
Study First Received: | November 4, 2005 |
Last Updated: | March 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00249301 |
Health Authority: | United States: Food and Drug Administration |
Breast Cancer Colon Cancer Pancreatic Cancer Bladder Cancer |
Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Urogenital Neoplasms Urologic Neoplasms Urologic Diseases Breast Diseases Endocrine Gland Neoplasms Bladder neoplasm Cystocele Digestive System Neoplasms Skin Diseases Urinary Bladder Diseases |
Urinary Bladder Neoplasms Breast Neoplasms Endocrine System Diseases Intestinal Diseases Intestinal Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Colonic Neoplasms Colorectal Neoplasms Urinary tract neoplasm |
Neoplasms Neoplasms by Site |