| General information |
| Database: | DB00573 |
| Objective: | Figitumumab is a fully human IgG2 monoclonal antibody targeting the insulinlike growthfactor1 receptor (IGF1R). Preclinical data suggest a dependence on insulinlike growthfactor signalling for sarcoma subtypes, including Ewing's sarcoma, and early reports show antitumour activity of IGF1Rtargeting drugs in these diseases. |
| Authors: | Olmos D, et al |
| Title: | Safety, pharmacokinetics, and preliminary activity of the antiIGF1R antibody figitumumab (CP751, 871) in patients with sarcoma and Ewing's sarcoma: a phase 1 expansion cohort study. |
| Journal: | Lancet Oncol. |
| Year: | 2010 |
| PMID: | 20036194 |
| Trial Design |
| Clinical Trial Id: | NCT00474760 |
| Agent: | figitumumab
|
| Target: | Insulinlike growth factor I receptor
|
| Cancer Type: | soft tissue sarcomas |
| Cancer Subtype: | Ewing¡¯s sarcoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase I expansioncohort study |
| Key Patients Feature: | patients with refractory, advanced sarcomas |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | The first cohort (n=15) included patients with multiple sarcoma subtypes, age 18 years or older, and the second cohort (n=14) consisted of patients with refractory Ewing's sarcoma, age 9 years or older. |
| Treatment Info: | pts received figitumumab (20 mg/kg) in two singlestage expansion cohorts within a solidtumourphase 1 trial. The first cohort (n=15) included patients with multiple sarcoma subtypes, age 18 years or older, and the second cohort (n=14) consisted of patients with refractory Ewing's sarcoma, age 9 years or older. |
| Primary End Point: | safety and tolerability |
| Secondary End Point: | pharmacokinetic profiling and preliminary antitumour activity |
| Patients Number: | 29 |
| Trial Results |
| DLT_MTD: | Grade 3 deep venous thrombosis, grade 3 back pain, and grade 3 vomiting wereeach noted once in individual patients; one patient had grade 3 increases in aspartate aminotransferase andgammaglutamyltransferase concentrations |
| Objective Response Rate: | two patients, both with Ewing¡¯s sarcoma, had objective responses (one complete responseand one partial response) and eight patients had disease stabilisation (six with Ewing¡¯s sarcoma, one with synovialsarcoma, and one with fi brosarcoma) lasting 4 months or longer. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Grade 3 deep venous thrombosis, grade 3 back pain, and grade 3 vomiting were each noted once in individual patients; one patient had grade 3 increases in aspartate aminotransferase and gammaglutamyltransferase concentrations. This patient also had grade 4 increases in alanine aminotransferase concentrations. The only other grade 4 adverse event was raised concentrations of uric acid, noted in one patient. |
| Conclusions: | Figitumumab is well tolerated and has antitumour activity in Ewing's sarcoma, warranting further investigation in this disease. |