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Sponsors and Collaborators: |
Hoffmann-La Roche Sarcoma Alliance for Research through Collaboration |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00642941 |
This single arm study will evaluate the efficacy and safety of R1507 in patients with recurrent or refractory sarcoma. Five cohorts of sarcoma patients will be studied in parallel: Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma, and other sarcomas. All patients will receive R1507 9mg/kg i.v. weekly. The anticipated time on study treatment is until disease progression or unacceptable adverse events, and the target sample size is 100-500 individuals.
Condition | Intervention | Phase |
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Sarcoma |
Drug: R1507 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of R1507, a Recombinant Human Monoclonal Antibody to the Insulin-Like Growth Factor-1 Receptor for the Treatment of Patients With Recurrent or Refractory Ewing's Sarcoma, Osteosarcoma, Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas. |
Estimated Enrollment: | 55 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | November 2013 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: R1507
9mg/kg iv weekly
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Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Please reference Study ID Number: NO21157 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | NO21157, SARC011 |
Study First Received: | March 19, 2008 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00642941 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Osteosarcoma Ewing's Sarcoma Insulin Recurrence Antibodies, Monoclonal Sarcoma, Synovial Neoplasms, Connective and Soft Tissue Antibodies Sarcoma, Ewing's |
Malignant Mesenchymal Tumor Soft Tissue Sarcomas Sarcoma Mitogens Osteogenic Sarcoma Synovial Sarcoma Ewing's Family of Tumors Immunoglobulins Rhabdomyosarcoma |
Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Histologic Type Sarcoma |