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Sponsored by: |
Antisoma Research |
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Information provided by: | Antisoma Research |
ClinicalTrials.gov Identifier: | NCT00111618 |
The purpose of this trial is to confirm a safe dose of AS1404, to be given with docetaxel, and to see whether adding AS1404 and docetaxel together improves the outcome of the treatment, when compared to docetaxel alone.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: AS1404 (DMXAA) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open Label, Randomized, Phase II Study of AS1404 in Combination With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer |
Estimated Enrollment: | 70 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | August 2006 |
The overall aim of this study is to determine the safety, tolerability and efficacy of AS1404 in combination with docetaxel in patients with hormone refractory metastatic prostate cancer.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hematological and biochemical indices at screening within the following ranges:
Adequate hepatic and renal function, as defined by:
Exclusion Criteria:
Treatment with the following medications within two weeks of AS1404 administration or the expected need for such treatments during the study period:
Principal Investigator: | Roberto Pili, MD | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Study ID Numbers: | AS1404-203 |
Study First Received: | May 24, 2005 |
Last Updated: | August 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00111618 |
Health Authority: | United States: Food and Drug Administration |
vascular disrupting agent safety tolerability efficacy hormone refractory prostate cancer |
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