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MLN4924 · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| MLN4924 + Fluconazole | EXPERIMENTAL | Part A: MLN4924, 8 milligram per square meter (mg/m\^2), intravenously, once on Days 1 and 8; and fluconazole, 400 milligram (mg), tablets, orally, once on Day 4, and 200 mg, once daily on Days 5-10. Part B: MLN4924, at a dose previously deemed tolerable, given on Days 1, 3, and 5 of each 21-day Cycle (Study C15010, Clinicaltrials.gov Identifier # NCT01862328) in combination with docetaxel or carboplatin + paclitaxel at standard dose regimen on Day 1 of each 21-day Cycle. |
| MLN4924 + Itraconazole | EXPERIMENTAL | Part A: MLN4924, 8-mg/m\^2, intravenously, once on Days 1 and 8; and itraconazole, 200 mg, oral solution, once daily on Days 4-10. Part A (safety lead-in step): MLN4924, 15mg/m\^2, intravenously, once on Days 1 and 8; and itraconazole, 200 mg, oral solution, once daily on Days 4-10. Part A: MLN4924, 20mg/m\^2, intravenously, once on Days 1 and 8; and itraconazole, 200 mg, oral solution, once daily on Days 4-10. Part B: MLN4924, at a dose previously deemed tolerable given, on Days 1, 3, and 5 of each 21-day Cycle (Study C15010, ClinicalTrails.gov Identifier # NCT01862328) in combination with docetaxel or carboplatin + paclitaxel at standard dose regimen on Day 1 of each 21-day Cycle. |
| MLN4924 and Docetaxel (Arm 1) | EXPERIMENTAL | - |
| MLN4924 + Paclitaxel + Carboplatin (Arm 2) | EXPERIMENTAL | - |
| MLN4924 + Gemcitabine (Arm 3) | EXPERIMENTAL | - |
| MLN4924 and Azacitidine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MLN4924 | DRUG | MLN4924 intravenous solution. |
| Fluconazole | DRUG | Fluconazole tablets. |
| Itraconazole | DRUG | Itraconazole oral solution. |
| Docetaxel | DRUG | Docetaxel intravenous solution. |
| Carboplatin | DRUG | Carboplatin intravenous solution. |
| Paclitaxel | DRUG | Paclitaxel intravenous solution. |
| Gemcitabine | DRUG | Gemcitabine (IV) in participants in a 28-day cycle: -Gemcitabine on Days 1,8,15 of each cycle |
| Azacitidine | DRUG | Azacitidine (IV) or subcutaneously in AML participants in a 28-day cycle: \- Azacitidine Days 1, 2, 3, 4, 5, 8, 9 in Cycle 1 and for all subsequent cycles |
Inclusion Criteria: 1. Male or female participants 18 years of age or older. 2. Must have a histologically or cytologically confirmed metastatic or locally advanced and incurable solid tumor that is deemed appropriate for treatment with 1 of the 2 chemotherapy regimens in Part B of this study, or h...
MLN4924 is an investigational small molecule being studied for the treatment of acute myelogenous leukemia (AML) and solid tumors, including advanced solid tumors. It is in Phase 1 clinical development and is not yet approved by the FDA.
MLN4924 is a small molecule that targets the NEDD8-activating enzyme (NAE), which plays a role in protein degradation pathways. By inhibiting NAE, it disrupts cellular processes that are important for tumor growth, though specific molecular targets have not been detailed.
MLN4924 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting Phase 1 clinical trials for this investigational drug in oncology indications.
MLN4924 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. All completed trials for MLN4924 are Phase 1 studies, and it remains in early-stage clinical testing.
MLN4924 has been studied in three completed Phase 1 trials: NCT01814826 for AML in patients 60 years or older, NCT01862328 for solid tumors, and NCT02122770 for advanced solid tumors. These trials were conducted in the United States.
MLN4924 is also known as pevonedistat, though this alternative name has not been officially confirmed. It is an investigational small molecule being developed by Takeda for oncology indications, and it is not yet approved for any use.