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Sponsored by: |
Millennium Pharmaceuticals, Inc. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00651664 |
This is a multicenter, dose escalation, phase 1 study of MLN8237 in adult patients with advanced malignancies (excluding those with primary bone marrow involvement, such as leukemias and multiple myeloma).
Condition | Intervention | Phase |
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Advanced Malignancies |
Drug: MLN8237 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment |
Official Title: | A Phase I Clinical and Pharmacodynamic Study of MLN8237, A Novel Aurora A Kinase Inhibitor, in Patients With Advanced Malignancies |
Estimated Enrollment: | 44 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
MLN8237
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Drug: MLN8237
Each dose of MLN8237 will be supplied in capsules of 5 to 25 mg and be given by mouth with 1 cup of water (approximately 240 ml) for 7 consecutive days, with treatment repeated every 21 days.
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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:
Contact: Christine Colby, PharmD | 1-866-835-2233 | medical@mlnm.com |
Spain | |
Ciutat Sanitaria Vall d'Hebron - Servicio de Oncologia | Recruiting |
Barcelona, Spain, 08035 | |
Contact: Josep C. Tabernero, MD |
Responsible Party: | Millennium Pharmaceuticals ( Clinical Study Medical Monitor ) |
Study ID Numbers: | C14002 |
Study First Received: | March 31, 2008 |
Last Updated: | April 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00651664 |
Health Authority: | United States: Food and Drug Administration; Spain: Spanish Agency of Medicines |
Neoplasms |