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Sponsors and Collaborators: |
Indiana University School of Medicine Novartis |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00731861 |
This study will evaluate PTK787, a new oral drug that stops blood vessel development, in combination with Paclitaxel in patients with advanced solid tumors.
Condition | Intervention | Phase |
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Neoplasm Metastasis Carcinoma |
Drug: Paclitaxel plus PTK787 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | Phase I, Pharmacokinetic, Pharmacodynamic Trial of PTK787 and Paclitaxel in Combination for Advanced Solid Tumors |
Enrollment: | 28 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Paclitaxel plus PTK787
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Drug: Paclitaxel plus PTK787
Paclitaxel will be given on days 1 and 15 over 28 days in cycle 1 with PTK787 on days 3 to 28. PTK787 WILL BE TAKEN AT NIGHT. In cycle 2 and beyond, paclitaxel will be given on days 1, 8 and 15 every 28 days . PTK787 will be taken orally NIGHTLY. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
United States, Indiana | |
Indiana University Simon Cancer Center | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Gabriela Chiorean, MD | Indiana University |
Responsible Party: | Indiana University Simon Cancer Center ( E. Gabriela Chiorean, MD ) |
Study ID Numbers: | 0412-21/ IUCRO-0101 |
Study First Received: | August 7, 2008 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00731861 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Paclitaxel Neoplasm Metastasis Vatalanib Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Protein Kinase Inhibitors |
Pharmacologic Actions Neoplasms Neoplastic Processes Pathologic Processes Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |