| General information |
| Database: | DB00569 |
| Objective: | Cixutumumab (IMCA12), a fully human immunoglobulin G1 (IgG1) monoclonal antibody, exerts preclinical activity in several sarcoma models and may be effective for the treatment of these tumours. |
| Authors: | Sch ffski P, et al |
| Title: | An openlabel, phase 2 study evaluating the efficacy and safety of the antiIGF1R antibody cixutumumab in patients with previously treated advanced or metastatic softtissue sarcoma or Ewing family of tumours. |
| Journal: | Eur J Cancer. |
| Year: | 2013 |
| PMID: | 23835252 |
| Trial Design |
| Clinical Trial Id: | NCT00668148 |
| Agent: | cixutumumab
|
| Target: | Insulinlike growth factor I receptor
|
| Cancer Type: | soft tissue sarcomas |
| Cancer Subtype: | advanced softtissue sarcoma or Ewing family of tumours |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | openlabel, 5tier, multicentre, multinational, phase II clinical trial |
| Key Patients Feature: | patients (P12 years ofage) had to have one of the five histologically or cytologically confirmed sarcomas (described above) that hadrelapsed or become refractory or metastatic, and wasincurable by surgery, radiotherapy or other conventional systemic therapy; measurable disease, as definedby the Response Evaluation Criteria in Solid Tumors RECIST) Version 1.024; evidence of disease progressionwithin the last 6 months; a life expectancy of >3 months;an Eastern Cooperative Oncology Group performancestatus (ECOG PS) of 0-1; adequate renal, liver, andhaematologic function (serum creatinine 61.5 timesthe institutional upper limit of normal [ULN] or creatinine clearance P60 mL/min for patients with creatininelevels above 1.5 times the ULN; total bilirubin 61.5times the ULN and aspartate transaminase and alaninetransaminase 63 times the ULN [or 65 times the ULNin the presence of known liver metastases]; and absoluteneutrophil count P1500/lL, haemoglobin P9 g/dL, and platelet count P100, 000/lL, respectively); and fasting serum glucose <120 mg/dL or below the ULN. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received intravenous cixutumumab (10mg/kg) for 1h every other week until disease progression or discontinuation. |
| Primary End Point: | progression free survival rate (PFR), defined as stable disease or better at 12 weeks. |
| Secondary End Point: | NA |
| Patients Number: | 113 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 6.1 for rhabdomyosarcoma, 6.0 for leiomyosarcoma, 12.1 for adipocytic sarcoma, 6.4 for synovial sarcoma and 6.4 for Ewing family of tumours. |
| Median OS A vs. C: | 23.6 (8.9-52.1) for rhabdomyosarcoma, NR for leiomyosarcoma, 46.4 (31.3-61.1) for adipocytic sarcoma, 56.3 (22.3-71.3) for synovial sarcoma and 24.1 (12.6-37.6) for Ewing family of tumours. |
| Adverse Event(agent arm): | the most frequent treatmentemergent adverse events (AEs) were nausea (26%), fatigue (23%), diarrhoea (23%) and hyperglycaemia (20%). |
| Conclusions: | Patients with adipocytic sarcoma may benefit from treatment with cixutumumab. Cixutumumab treatment was well tolerated, with limited gastrointestinal AEs, fatigue and hyperglycaemia. |