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Sponsored by: |
Cell Genesys |
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Information provided by: | Cell Genesys |
ClinicalTrials.gov Identifier: | NCT00103428 |
V-0039 is a Phase 1/2 dose escalation trial of CG7870 in combination with Docetaxel in metastatic hormone-refractory patients who have not received chemotherapy.
All patients will receive docetaxel. In the dose escalation phase of the study, patients will receive treatment intravenously with CG7870 at one of up to four dose levels. In the Phase 2 portion of this study, additional patients will be added at the maximum tolerated dose that is determined in Phase 1.
Condition | Intervention | Phase |
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Prostate Cancer |
Biological: CG7870 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1/2a Dose-Escalation Trial of Intravenous CG7870 in Combination With Docetaxel in Chemotherapy-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | V-0039 |
Study First Received: | February 8, 2005 |
Last Updated: | January 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00103428 History of Changes |
Health Authority: | United States: Food and Drug Administration |
chemotherapy prostate cancer cancer metastatic |
hormone refractory chemotherapy naive dose escalation |
Docetaxel Prostatic Diseases Genital Neoplasms, Male Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Urogenital Neoplasms Genital Diseases, Male Hormones Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Urogenital Neoplasms Genital Diseases, Male Hormones Prostatic Neoplasms Pharmacologic Actions |