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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Collaborator: |
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: | 180 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | July 2014 |
| 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 | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Hide Study Locations| United States, California | |
| Recruiting | |
| Santa Monica, California, United States, 90403 | |
| Recruiting | |
| Stanford, California, United States, 94305 | |
| Recruiting | |
| Duarte, California, United States, 91010 | |
| Not yet recruiting | |
| West Hollywood, California, United States, 90048 | |
| Not yet recruiting | |
| Los Angeles, California, United States, 90095 | |
| Recruiting | |
| Los Angeles, California, United States, 90095-1752 | |
| United States, District of Columbia | |
| Recruiting | |
| Washington, District of Columbia, United States, 20010-2931 | |
| United States, Florida | |
| Not yet recruiting | |
| Gainesville, Florida, United States, 32610 | |
| Not yet recruiting | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Not yet recruiting | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Idaho | |
| Recruiting | |
| Coeur D'alene, Idaho, United States, 83814 | |
| United States, Maryland | |
| Recruiting | |
| Bethesda, Maryland, United States, 20892-1926 | |
| Recruiting | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Recruiting | |
| Boston, Massachusetts, United States, 01225-6084 | |
| Recruiting | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Recruiting | |
| Ann Arbor, Michigan, United States, 48109-0848 | |
| United States, Minnesota | |
| Not yet recruiting | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Nebraska | |
| Recruiting | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New Jersey | |
| Recruiting | |
| Charlotte, New Jersey, United States, 28203 | |
| United States, New York | |
| Recruiting | |
| New York, New York, United States, 10021 | |
| Recruiting | |
| Bronx, New York, United States, 10467 | |
| Recruiting | |
| New York, New York, United States, 10065 | |
| United States, Oregon | |
| Recruiting | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Recruiting | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Recruiting | |
| Philadelphia, Pennsylvania, United States, 19111-2412 | |
| United States, Tennessee | |
| Not yet recruiting | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Recruiting | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Recruiting | |
| Salt Lake City, Utah, United States, 84108 | |
| United States, Washington | |
| Not yet recruiting | |
| Seattle, Washington, United States, 98105 | |
| Australia | |
| Not yet recruiting | |
| Westmead, Australia, 2145 | |
| Recruiting | |
| Melbourne, Australia, 3002 | |
| Not yet recruiting | |
| Sydney, Australia, 2050 | |
| Canada, British Columbia | |
| Recruiting | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| France | |
| Recruiting | |
| Lyon, France, 69008 | |
| Not yet recruiting | |
| Marseille, France, 13005 | |
| Not yet recruiting | |
| Villejuif, France, 94805 | |
| Recruiting | |
| Lille, France, 59000 | |
| Recruiting | |
| Bordeaux, France, 33076 | |
| Recruiting | |
| Villejuif, France, 94805 | |
| Recruiting | |
| Paris, France, 75248 | |
| Germany | |
| Not yet recruiting | |
| Frankfurt Am Main, Germany, 60325 | |
| Not yet recruiting | |
| Mannheim, Germany, 68167 | |
| Recruiting | |
| Mannheim, Germany, 68167 | |
| Recruiting | |
| Münster, Germany, 481249 | |
| Recruiting | |
| Tübingen, Germany, 72076 | |
| Recruiting | |
| Bad Saarow, Germany, 15526 | |
| Italy | |
| Recruiting | |
| Bologna, Italy, 40136 | |
| Recruiting | |
| Milano, Italy, 20133 | |
| Netherlands | |
| Recruiting | |
| Rotterdam, Netherlands, 3075 AE | |
| Norway | |
| Recruiting | |
| Oslo, Norway, 0310 | |
| Spain | |
| Not yet recruiting | |
| Barcelona, Spain, 08025 | |
| Not yet recruiting | |
| Barcelona, Spain, 08907 | |
| Recruiting | |
| Barcelona, Spain, 08950 | |
| Not yet recruiting | |
| Palma de Mallorca, Spain, 07014 | |
| Not yet recruiting | |
| Madrid, Spain, 28041 | |
| Sweden | |
| Recruiting | |
| Lund, Sweden, 22185 | |
| Not yet recruiting | |
| Stockholm, Sweden, 76 | |
| United Kingdom | |
| Not yet recruiting | |
| Birmingham, United Kingdom, B15 2TH | |
| Recruiting | |
| London, United Kingdom, NW1 2PG | |
| Recruiting | |
| London, United Kingdom, SW3 6JJ | |
| Not yet recruiting | |
| Birmingham, United Kingdom, B4 6NH | |
| Active, not recruiting | |
| Manchester, United Kingdom, M20 4BX | |
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Hoffmann-La Roche ( Disclosures Group ) |
| Study ID Numbers: | NO21157, SARC011 |
| Study First Received: | March 19, 2008 |
| Last Updated: | November 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00642941 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Histologic Type Sarcoma |