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| Sponsors and Collaborators: |
Hoffmann-La Roche Sarcoma Alliance for Research through Collaboration |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00642941 |
Purpose
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 |
|---|---|---|
|
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: | November 2007 |
| Estimated Study Completion Date: | November 2013 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: R1507
9mg/kg iv weekly
|
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Please reference Study ID Number: NO21157 | 973-235-5000 | |
| Contact: Please reference Study ID Number: SARC011 | 734-930-7600 |
Show 63 Study Locations| Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
More Information
| Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
| Study ID Numbers: | NO21157, SARC011 |
| Study First Received: | March 19, 2008 |
| Last Updated: | June 16, 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 |