Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00859040 | Monthly SOM230C for Recurrent or Progressive Meningioma | PHASE2 | COMPLETED | 34 | — | — | Mar 1, 2009 | Jan 1, 2016 | Oct 27, 2017 | 8 | United States |
Progression is defined using Modified Macdonald Criteria , using a \>/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
| Arm | Type | Description |
|---|---|---|
| SOM230C | EXPERIMENTAL | Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial) |
| Name | Type | Description |
|---|---|---|
| SOM230C | DRUG | Injection in the buttocks every 28 days |
Inclusion Criteria: * 18 years of age or older * Radiographically measurable disease on contrast-enhanced MRI or CT images * Karnofsky Performance status of 60 or greater * Life expectancy of at least 3 months * Histologically confirmed diagnosis of recurrent or progressive intracranial meningioma(...