| March 19, 2008 |
| November 17, 2009 |
| November 2007 |
| |
- Objective response rate [ Time Frame: Week 24, and every 12 weeks thereafter ] [ Designated as safety issue: No ]
- Progression-free survival in patients with Ewing's sarcoma [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
|
| Same as current |
| Complete list of historical versions of study NCT00642941 on ClinicalTrials.gov Archive Site |
- Duration of response, PFS. [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
- Overall PFS. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
- Overall objective response rate, response duration, overall PFS and overall survival in patients with Ewing's sarcoma. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| A Study of R1507 in Patients With Recurrent or Refractory Sarcoma. |
| 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. |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Sarcoma |
| Drug: R1507 |
| |
| |
| |
| Recruiting |
| 180 |
| July 2014 |
|
Inclusion Criteria:
- patients >=2 years of age;
- progressive, recurrent or refractory Ewing's sarcoma, or recurrent or refractory osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other sarcomas of the following sub-types: alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma and myxoid liposarcoma.
Exclusion Criteria:
- clinically significant unrelated systemic illness which would compromise the patient's ability to tolerate the investigational agent, or interfere with the study procedures or results;
- known hypersensitivity to any of the components of R1507 or prior hypersensitivity reactions to monoclonal antibodies;
- current or previous treatment (within last 6 months) with chronic pharmacological doses of corticosteroids, immunosuppressive agents or medications that inactivate or may interfere with the pharmacological activity of R1507;
- current or prior therapy with IGF inhibitor (monoclonal or specific kinase inhibitor);
- history of solid organ transplant;
- other malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer.
|
| Both |
| 2 Years and older |
| No |
|
|
| United States, Australia, Canada, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom |
| |
| NCT00642941 |
| Disclosures Group, Hoffmann-La Roche |
| NO21157, SARC011 |
| Hoffmann-La Roche |
| Sarcoma Alliance for Research through Collaboration |
| Study Director: |
Clinical Trials |
Hoffmann-La Roche |
|
|
| Hoffmann-La Roche |
| November 2009 |