| General information |
| Database: | DB00572 |
| Objective: | They conducted a multicenterphase II study of the fully human IGF1R monoclonal antibody R1507 in patients with recurrent or refractory ESFT. |
| Authors: | Pappo AS, et al |
| Title: | R1507, a monoclonal antibody to the insulinlike growth factor 1 receptor, in patients with recurrent or refractory Ewing sarcoma family of tumors: results of a phase II Sarcoma Alliance for Research through Collaboration study. |
| Journal: | J Clin Oncol. |
| Year: | 2011 |
| PMID: | 22025149 |
| Trial Design |
| Clinical Trial Id: | NCT00642941 |
| Agent: | R1507
|
| Target: | Insulinlike growth factor I receptor
|
| Cancer Type: | soft tissue sarcomas |
| Cancer Subtype: | Ewing Sarcoma Family of Tumors |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Results of a phase II |
| Key Patients Feature: | Eligibility criteria included a centrally revietheyd pathology, age 2 years, lifeexpectancy of 6 weeks, Karnofsky/Lansky performance status 70%, bidimensionally measurable disease by computed tomography or magneticresonance imaging, signed informed consent, adequate bone marrow, liver, and renal function. A molecular confirmation of ESFT diagnosis was notrequired for eligibility.Patients with CNS disease must have been off glucocorticoids for 4weeks without neurologic deficit. Patients must have completed previoussurgery and systemic or radiation therapy 3 weeks before enrollment.Patients treated with brain irradiation must have must have completed therapy 6 weeks before enrollment. Contraception was required in appropriatepatients. |
| Biomarker: | NA |
| Biomark Analysis: | The identification of markers that are predictive of a benefit is necessary to fully capitalize on this approach. |
| Control Group Info: | single arm |
| Treatment Info: | pts received R1507 at doses of 9 mg/kg intravenously one a week or 27 mg/kg intravenously every three weeks. Response was measured by using WHO criteria. Tumor imaging was performed every 6 weeks for 24 weeks and then every 12 weeks. |
| Primary End Point: | ORR, PFS, OS, toxicities |
| Secondary End Point: | NA |
| Patients Number: | 115 |
| Trial Results |
| DLT_MTD: | The most common adverseevents of grades 3 to 4 were pain (15%), anemia (8%), thrombocytopenia (7%), andasthenia (5%). |
| Objective Response Rate: | The overall complete response/partial response rate was 10% (95% CI, 4.9% to 16.5%). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 7.6 months (95% CI, 6 to 9.7 months) |
| Adverse Event(agent arm): | The most common adverse events of grades 3 to 4 were pain (15%), anemia (8%), thrombocytopenia (7%), and asthenia (5%). |
| Conclusions: | R1507 was a welltolerated agent that had meaningful and durable benefit in a subgroup of patients with ESFT. The identification of markers that are predictive of a benefit is necessary to fully capitalize on this approach. |