| General information |
| Database: | DB00571 |
| Objective: | Ganitumab is a fully human monoclonal antibody against type1 insulinlike growth factor receptor (IGF1R). An openlabelphase II study was conducted to evaluate the efficacy and safety of ganitumab monotherapy in patients with metastatic Ewing family tumors (EFT) or desmoplastic small round cell tumors (DSRCT). |
| Authors: | Tap WD, et al |
| Title: | Insulin growth factorreceptor (IGF1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with refractory Ewing's sarcoma family tumors. |
| Journal: | J Clin Oncol. |
| Year: | 2012 |
| PMID: | 22508822 |
| Trial Design |
| Clinical Trial Id: | NCT00563680 |
| Agent: | cixutumumab
|
| Target: | Insulinlike growth factor I receptor
|
| Cancer Type: | soft tissue sarcomas |
| Cancer Subtype: | Ewing's sarcoma family tumors |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | cixutumumab combined with the mTOR inhibitor temsirolimus |
| Study Type: | a phase II study |
| Key Patients Feature: | patients with refractory Ewing's sarcoma family tumors |
| Biomarker: | NA |
| Biomark Analysis: | Elevation of IGF1 levels was observed postdose. EWSFli1 translocations were analyzed by RNA sequencing and fluorescent in situ hybridization, and novel translocations were observed in EFT and DSCRT. No apparent relationship between tumor response and IGF1 levels or EWS gene translocations was observed. |
| Control Group Info: | single arm |
| Treatment Info: | pts received 12 mg/kg of ganitumab every 2 weeks. The relationship between tumor response and EWS gene translocation status and IGF1 levels was evaluated. |
| Primary End Point: | Objective response rate (ORR) |
| Secondary End Point: | clinical benefit rate (CBR = complete + partial responses + stable disease [SD] more than and equal to 24 weeks) and safety and pharmacokinetic profiles |
| Patients Number: | 38 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Of 35 patients assessed for response, two had partial responses (ORR, 6%) and 17 (49%) had SD. Four patients had SD more than and equal to 24 weeks, contributing to a CBR of 17%. The pharmacokinetic profile of ganitumab was similar to that observed in the firstinhuman trial. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 7.9 months (95% CI, 5.4 to 25.6 months) for patients with EFT and 19.0 months (95% CI, 8.3 to 32.4 months) for patients with DSRCT. |
| Median OS A vs. C: | NR(not reached) |
| Adverse Event(agent arm): | Grade 3 related events included hyperglycemia (n 2), thrombocytopenia (n 5), neutropenia (n 2), leukopenia (n 1), and transient ischemic attack (n 1). There were no grade 4 or 5 treatmentrelated events. |
| Conclusions: | Ganitumab was well tolerated and demonstrated antitumor activity in patients with advanced recurrent EFT or DSRCT. |