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Ultratrace iobenguane I 131 · 2 trials · 3 indications
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...
Ultratrace iobenguane I 131 is an investigational small molecule being studied for the treatment of pheochromocytoma, a rare tumor of the adrenal gland. It is also being evaluated in patients with paraganglioma and metastatic carcinoid. The drug is in Phase 1 clinical development and has not been approved by the FDA.
Ultratrace iobenguane I 131 is being developed by Insight Molecular Diagnostics Inc., a company listed on the stock exchange under the ticker IMDX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with pheochromocytoma and related neuroendocrine tumors.
Ultratrace iobenguane I 131 is currently in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 48 patients enrolled. The drug remains investigational and is not yet approved for commercial use.
Ultratrace iobenguane I 131 has been studied in two completed Phase 1 trials. NCT00339131 enrolled 24 patients with malignant pheochromocytoma, paraganglioma, or metastatic carcinoid. NCT00458952 enrolled 24 patients with malignant pheochromocytoma or paraganglioma in the United States. Both trials were uncontrolled and not randomized.
Yes, Ultratrace iobenguane I 131 is a formulation of iobenguane I 131, also known as MIBG I 131. The drug is a radioactive small molecule that is being investigated for its ability to target and treat neuroendocrine tumors such as pheochromocytoma and paraganglioma.