| General information |
| Database: | DB00568 |
| Objective: | Insulinlike growth factor1 receptor (IGF1R) is implicated in the pathogenesis of rhabdomyosarcoma (RMS), osteosarcoma (OS), and synovial sarcoma (SS). The authors conducted a multiinstitutionalphase 2 trial of the monoclonal antibody R1507 in patients with various subtypes of recurrent or refractory sarcomas. |
| Authors: | Pappo AS, et al |
| Title: | a phase 2 trial of R1507, a monoclonal antibody to the insulinlike growth factor1 receptor (IGF1R), in patients with recurrent or refractory rhabdomyosarcoma, osteosarcoma, synovial sarcoma, and other soft tissue sarcomas: results of a Sarcoma Alliance for Research Through Collaboration study. |
| Journal: | cancer |
| Year: | 2014 |
| PMID: | 24797726 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | R1507
|
| Target: | Insulinlike growth factor I receptor
|
| Cancer Type: | soft tissue sarcomas |
| Cancer Subtype: | rhabdomyosarcoma, osteosarcoma, synovial sarcoma, and other soft tissue sarcomas |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase II Trial |
| Key Patients Feature: | Eligibility included a centrally histologically verified diagnosis of RMS, highgrade OS, synovial sarcoma, or othersarcoma; age >2 years; a life expectancy of at least 6 weeks;a Karnofsky=Lansky performance status >70%; bidimensionally measurable disease by computed tomography ormagnetic resonance imaging; adequate bone marrow, liver, and renal function; and off chemotherapy for at least3 weeks. Patients with central nervous system disease hadno overt neurologic deficit, were off glucocorticoids for atleast 4 weeks, and were off irradiation for >6 weeks. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received a weekly dose of 9 mg/kg R1507 intravenously. Tumor imaging was performed every 6 weeks ¡Á 4 and every 12 weeks thereafter. |
| Primary End Point: | best objective response rate |
| Secondary End Point: | NA |
| Patients Number: | 163 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The overall objective response rate was 2.5% (95% confidence interval, 0.7%6.2%). Partial responses were observed in 4 patients, including 2 patients with OS, 1 patient with RMS, and 1 patient with alveolar soft part sarcoma. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5.7 weeks (95% CI, 5.65.9 weeks) |
| Median OS A vs. C: | 11.2 months (95% CI, 9.413.1 months) |
| Adverse Event(agent arm): | The most common grade 3=4 toxicities were metabolic (12%), hematologic (6%), gastrointestinal (4%), and general constitutional symptoms (8%). |
| Conclusions: | R1507 is safe and well tolerated but has limited activity in patients with recurrent or refractory bone and soft tissue sarcomas. Additional studies to help identify the predictive factors associated with clinical benefit in selected histologies such as RMS appear to be warranted. |