| General information |
| Database: | DB00624 |
| Objective: | Thisphase II study evaluated the efficacy and safety of AMG 102 (rilotumumab), a fully human monoclonal antibody against hepatocyte growth factor/scatter factor (HGF/SF), in patients with recurrent glioblastoma (GBM). Patients with histologically confirmed, measurable recurrent GBM or gliosarcoma (World Health Organization grade 4) and less than and equal to 3 relapses or prior systemic therapies received AMG 102 (10 or 20 mg/kg) by infusion every 2 weeks. |
| Authors: | theyn PY, et al |
| Title: | a phase II study evaluating the efficacy and safety of AMG 102 (rilotumumab) in patients with recurrent glioblastoma. |
| Journal: | Neuro Oncol. |
| Year: | 2011 |
| PMID: | 21297127 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | AMG102
|
| Target: | hepatocyte growth factor/scatter factor (HGF/SF)
|
| Cancer Type: | Tumors of the nervous system |
| Cancer Subtype: | glioblastoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | multicenter, openlabel, singleagent, IIstage, phaseII study |
| Key Patients Feature: | (aged more than and equal to 18 years) had histologicallyconfirmed GBM or gliosarcoma (World HealthOrganization grade 4), bidimensionally measurableand recurrent disease as assessed by MRI, Karnofskyperformance score more than and equal to 60%, less than and equal to 3 prior relapses or systemictreatments, and archived tissue from initial diagnosis orupon transformation to glioblastoma. |
| Biomarker: | Plasma total HGF/SF and soluble cMet concentrations |
| Biomark Analysis: | Plasma total HGF/SF and soluble cMet concentrations increased 12.05 and 1.12fold, respectively, from baseline during AMG 102 treatment. |
| Control Group Info: | single arm |
| Treatment Info: | pts received AMG 102 (10 or 20 mg/kg) by infusion every 2 weeks. |
| Primary End Point: | best confirmed objective response rate (central assessment) |
| Secondary End Point: | NA |
| Patients Number: | 61 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | There were no objective responses per central assessment, but 1 patient had an objective response per investigatorassessment. Median overall survival (95% CI) in the 10 and 20mg/kg cohorts was 6.5 months (4.1-9.8)and 5.4 months (3.4-11.4), respectively |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | progression free survival (PFS) per central assessment was 4.1 weeks (4.0-4.1) and 4.3 weeks (4.1-8.1), respectively. PFS was similar among patients who had previously received bevacizumab compared with bevacizumabnaive patients. |
| Median OS A vs. C: | Median overall survival (95% CI) in the 10 and 20mg/kg cohorts was 6.5 months (4.1-9.8) and 5.4 months (3.4-11.4), respectively |
| Adverse Event(agent arm): | The most common adverse events were fatigue (38%), headache (33%), and peripheral edema (23%). |
| Conclusions: | AMG 102 monotherapy at doses up to 20 mg/kg was not associated with significant antitumor activity in heavily pretreated patients with recurrent GBM. |