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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00543712 |
This is a multicenter, open-label, Phase II trial designed to evaluate the efficacy and safety of Apomab when given as a single agent in patients with advanced chondrosarcoma. Up to 90 patients with confirmed chondrosarcoma will be enrolled.
Condition | Intervention | Phase |
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Chondrosarcoma |
Drug: apomab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Phase II, Open-Label, Multicenter Study of the Efficacy and Safety of Single-Agent Apomab in Patients With Advanced Chondrosarcoma |
Estimated Enrollment: | 90 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: apomab
Intravenous repeating dose
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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:
Responsible Party: | Genentech, Inc. ( Sandra Skettino, M.D., Study Director ) |
Study ID Numbers: | APM4171g |
Study First Received: | October 12, 2007 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00543712 |
Health Authority: | United States: Food and Drug Administration |
Sarcoma synovial sarcoma |
Sarcoma, Synovial Neoplasms, Connective and Soft Tissue Synovial sarcoma Malignant mesenchymal tumor |
Chondrosarcoma Sarcoma Soft tissue sarcomas |
Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue |