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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00458952 | Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma | PHASE1 | COMPLETED | 24 | — | — | Apr 1, 2007 | Jun 1, 2011 | Jul 13, 2016 | 3 | United States |
| NCT00339131 | ULTRATRACE Iobenguane I 131 in Patients With Malignant Pheochromocytoma, Paraganglioma, or Metastatic Carcinoid | PHASE1 | COMPLETED | 24 | — | — | Jun 1, 2006 | Jan 1, 2007 | Oct 12, 2011 | - | — |
Although no primary efficacy endpoint was defined for this study, the MTD of Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma (a safety rather than an efficacy parameter) is the primary objective.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | Dosing of Ultratrace iobenguane I 131 began at 6.0 mCi/kg and escalated in 1.0 mCi/kg increments in order to establish the MTD. The MTD is the dose immediately below the level at which escalation stops due to dose-limiting toxicity (DLT). An additional 3 patients are to be treated at the MTD, for a total of 6. |
| Name | Type | Description |
|---|---|---|
| Ultratrace Iobenguane (MIBG) I 131 | DRUG | Phase I: Dose escalation protocol Phase II: Treatment schedule at therapeutic dose |
| Ultratrace iobenguane I 131 | DRUG | - |
Inclusion Criteria: * Have a diagnosis of either adrenal pheochromocytoma or extra-adrenal paraganglioma by histological confirmation OR plasma-free metanephrines and 24-hour urine test for catecholamines/ metanephrines * Disease is metastatic or has recurred following surgery * At least one measur...