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Sponsored by: |
Millennium Pharmaceuticals, Inc. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00652158 |
This is a phase 1 clinical trial designed to evaluate increasing durations of MLN8054 oral dosing in patients with advanced malignancies. MLN8054 will be given once daily for 4 to 7 consecutive days per week for 2 to 3 weeks. Following the 2- to 3-week treatment period there will be a 2 week recovery period.
Condition | Intervention | Phase |
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Advanced Malignancies |
Drug: MLN8054 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Phase 1 Trial of Extended MLN8054 Dosing in Patients With Advanced Malignancies |
Estimated Enrollment: | 60 |
Study Start Date: | April 2006 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: MLN8054
10 mg doses of MLN8054 were given orally once daily following a schedule of "5 days on/2 days off/5 days on" repeated every 28 days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
Willingness to have serial skin punch biopsies obtained and, if feasible, to have serial biopsies of tumor tissue obtained before and following the first dose of MLN8054 Note: Once the relationship between drug exposure and inhibition of Aurora A kinase activity has been established, patients subsequently enrolled in the study will not be required to undergo either tumor or skin biopsies.
8. Recovered from the reversible effects of prior antineoplastic therapy with at least 4 weeks elapsed since the last exposure to cytotoxic chemotherapy or radiotherapy and at least 6 weeks elapsed since exposure to nitrosoureas or mitomycin C. Patients treated with fully human monoclonal antibodies must not have received treatment with such antibodies for at least 6 weeks, and those treated with chimeric monoclonal antibodies must not have received treatment with such antibodies for at least 4 weeks. Patients treated with noncytotoxic small molecule drugs (eg, tyrosine kinase inhibitors such as Tarceva and hormonal agents such as Femara®) must not have received treatment with these drugs for at least 2 weeks before the first dose of MLN8054 is given.
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
Note: criteria 22, 23, and 24 apply only to patients in whom biopsy of tumor tissue is planned.
Responsible Party: | Millennium Pharmaceuticals, Inc. ( Clinical Study Medical Monitor ) |
Study ID Numbers: | C10002 |
Study First Received: | March 31, 2008 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00652158 |
Health Authority: | Spain: Ministry of Health |
Neoplasms |