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Sponsored by: |
Synta Pharmaceuticals, Corp. |
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Information provided by: | Synta Pharmaceuticals, Corp. |
ClinicalTrials.gov Identifier: | NCT00087997 |
The purpose of this study is to evaluate the safety and effectiveness of an experimental study drug (STA-4783) combined with an approved cancer medicine, paclitaxel, in the treatment of soft tissue sarcomas. Paclitaxel (Taxol®) has been approved and used in the United States since 1992.
Condition | Intervention | Phase |
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Soft Tissue Sarcoma |
Drug: STA-4783 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 80 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | October 2005 |
STA-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel. In an attempt to improve efficacy, paclitaxel is sometimes used in combination with other anticancer agents. When paclitaxel is combined with other anticancer agents, although response rate is usually increased, side effects are usually increased as well. There is an urgent need for agents that can enhance the antitumor effects of paclitaxel without further increasing undesirable side effects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Prior malignancy other than soft tissue sarcoma (STS) within the last 5 yrs with the exception of:
Study ID Numbers: | 4783-04 |
Study First Received: | July 19, 2004 |
Last Updated: | June 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00087997 |
Health Authority: | United States: Food and Drug Administration |
sarcoma |
Neoplasms, Connective and Soft Tissue Paclitaxel Malignant mesenchymal tumor Sarcoma Soft tissue sarcomas |
Neoplasms Neoplasms by Histologic Type |