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Mibefradil with Radiation · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Mibefradil with Radiation | EXPERIMENTAL | Patients will receive mibefradil dihydrochloride, which will be dose escalated from 150mg/day until the maximum tolerated dose (MTD) is determined, or until a dose of 350 mg/day is reached using a standard 3 + 3 design. Mibefradil dihydrochloride will be dosed orally in 4 divided doses per day for 17 consecutive days to the MTD. This will be given concurrently with hypofractionated radiation therapy. |
| Name | Type | Description |
|---|---|---|
| Mibefradil with Radiation | DRUG | Patients will receive mibefradil dihydrochloride, which will be dose escalated from 150mg/day until the maximum tolerated dose (MTD) is determined, or until a dose of 350 mg/day is reached using a standard 3 + 3 design. Mibefradil dihydrochloride will be dosed orally in 4 divided doses per day for 17 consecutive days to the MTD. This will be given concurrently with hypofractionated radiation therapy. |
Inclusion Criteria: * Sign written informed consent. * Histologically proven glioblastoma multiforme (GBM) that is progressive or recurrent following standard radiation therapy (RT) and temozolomide (i.e., at least "biopsy-proven" recurrent disease). Previous salvage therapies after first recurrenc...
Mibefradil with Radiation is an investigational small molecule being studied for use in Glioblastoma Multiforme (GBM), a type of brain cancer. It is being developed by Jazz Pharmaceuticals plc (JAZZ) and is currently in Phase 1 clinical development. The drug has also been studied in healthy volunteers.
Mibefradil with Radiation is being developed by Jazz Pharmaceuticals plc, which trades under the ticker symbol JAZZ. The company is conducting clinical trials to evaluate the drug's safety and potential use in treating Glioblastoma Multiforme (GBM).
Mibefradil with Radiation is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed to assess its safety in healthy volunteers and in patients with Glioblastoma Multiforme (GBM).
Mibefradil with Radiation has been studied in two completed Phase 1 trials. NCT01550458 evaluated the drug given four times a day in 30 healthy volunteers in the United States. NCT02202993 studied mibefradil combined with hypofractionated re-irradiation therapy in 18 patients with recurrent Glioblastoma Multiforme (GBM).
Mibefradil with Radiation is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trials have focused on safety and dosing, and the drug has not yet progressed to later-stage trials or regulatory submission.