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Brigatinib · 1 trial · 5 indications
Radiographic response rates in target tumors according to tumor-associated criteria: * VS, non-VS, and meningiomas: Dombi criteria (2013) * Ependymomas: RECIST 1.12
| Arm | Type | Description |
|---|---|---|
| Sub-study A (brigatinib) - CLOSED TO ENROLLMENT | EXPERIMENTAL | Subjects treated in this arm will receive brigatinib 90 mg by mouth daily for 7 days and then increased to 180 mg by mouth daily if the drug is tolerated. |
| Sub-study B (neratinib) | EXPERIMENTAL | The first three participants treated in this arm will receive neratinib 200 mg mg by mouth daily. If these participants tolerate the medication well, subsequent participants will receive neratinib 240 mg by mouth daily. |
| Experimental: sub-study C (retifanlimab plus bevacizumab) | EXPERIMENTAL | Subjects on this arm will receive retifanlimab by IV infusion at a dose of 375 mg every 3 weeks on a continuous schedule for 48 weeks. Subjects will also receive bevacizumab by IV infusion at a dose of 7.5 mg/kg every 3 weeks on an intermittent schedule. One cycle last 42 days and the study will last for 52 total weeks (48 treatment weeks and 4 follow-up weeks). |
| Name | Type | Description |
|---|---|---|
| Brigatinib | DRUG | Oral daily per predetermined dosage per protocol. |
| Neratinib | DRUG | Oral daily per predetermined dosage per protocol. |
| Retifanlimab | DRUG | Every 3 weeks by IV per predetermined dose in protocol. |
| Bevacizumab | DRUG | Every 3 weeks by IV per predetermined dose in protocol. |
Eligibility Specific For MASTER PROTOCOL: Inclusion Criteria: \- Patients must have a pathogenic variant in the NF2 gene (either in the germline or in two NF2-related tumors) OR a confirmed diagnosis of NF2 by fulfilling National Institute of Health (NIH) criteria or Manchester criteria: The NIH ...
Brigatinib is an investigational small molecule being studied for the treatment of Neurofibromatosis Type 2, a condition that can cause tumors such as vestibular schwannomas, non-vestibular schwannomas, meningiomas, and ependymomas. It is currently in Phase 2 clinical development and is not yet approved for this indication.
Brigatinib targets ALK and EGFR, acting as an inhibitor of these molecular targets. It is being evaluated in Neurofibromatosis Type 2 to determine if inhibiting these pathways can help treat the tumors associated with the condition.
Brigatinib is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Neurofibromatosis Type 2.
Brigatinib is in Phase 2 clinical development for Neurofibromatosis Type 2. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its potential as a treatment.
Brigatinib is being studied in the clinical trial NCT04374305, titled 'Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)'. This Phase 2 trial is recruiting participants in the United States and has an enrollment of 109 patients.
Brigatinib is a distinct drug with the ChEMBL identifier CHEMBL3545311. It is not known by any other names in the available information. It is being investigated specifically for its potential role in treating Neurofibromatosis Type 2.