Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Histone deacetylase inhibitor, HDAC6 inhibitor
ACY-1215 · 3 trials · 1 indication
Identify the MTD of ACY-1215 administered in an alternative liquid formulation (ALF) if present, and identify a recommended dose and schedule. Patients will be followed for completion of 6 28-day Cycles of Study Treatment (for ITT Population analysis).
Number of participants with Dose Limiting Toxicity (DLT)
Maximum Tolerated Dose is defined as the dose level immediately below the DLT dose level.
The objective response rate is the proportion of subjects achieving an investigator conformed partial response (PR) or better, to treatment according to IMWG (International Myeloma Working Group).
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Cohort | EXPERIMENTAL | Dose Escalating Cohorts of ACY-1215 in combination with pomalidomide and dexamethasone. |
| ACY-1215, Lenalidomide and Dexamethasone | EXPERIMENTAL | Open label dosing cohorts will evaluate oral ACY-1215 (doses ranging from 40 - 480 mg days 1-5, 8-12, 15-19) in combination with oral Lenalidomide (doses ranging from 15 - 25 mg days 1-21) and oral Dexamethasone (40 mg once weekly). |
| Treat Regimen | EXPERIMENTAL | ACY-1215 Bortezomib Dexamethasone |
| Name | Type | Description |
|---|---|---|
| ACY-1215 in combination with pomalidomide and dexamethasone | DRUG | Escalating dose Cohorts to determine a potential Maximum Tolerated Dose to recommend for a dosing schedule. |
| ACY-1215 | DRUG | Dose escalation up to 480 mg administered orally on Days 1-5, 8-12 and 15-19 of a 28 day dosing schedule. |
| lenalidomide | DRUG | Dosed on Days 1-21 of a 28 day cycle. |
| Dexamethasone | DRUG | Dosed on Days 1, 8, 15 and 22 of a 28 day treatment cycle. |
Key Inclusion Criteria Includes: Patients meeting all of the following criteria may be enrolled in the study: 1. Must be able to understand and voluntarily sign an ICF. 2. Must be registered into the mandatory POMALYST Risk Evaluation and Mitigation Strategy (REMS)™ program, and be willing and abl...
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ACY-1215 is an investigational small molecule being studied in multiple myeloma, a cancer of plasma cells in the bone marrow. It has been evaluated in Phase 1 clinical trials, both as a single agent and in combination with other myeloma therapies. It is not an approved medicine and remains in clinical development.
ACY-1215 has been studied in multiple myeloma, including relapsed and relapsed-and-refractory disease. Trials have tested it alongside pomalidomide and dexamethasone, lenalidomide and dexamethasone, and bortezomib and dexamethasone. All studies were Phase 1 and have completed; ACY-1215 is not approved for any use.
ACY-1215 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 1 multiple myeloma studies of ACY-1215, including evaluations of the drug alone and in combination with other agents.
ACY-1215 is in Phase 1 development. Three Phase 1 trials in multiple myeloma have been completed, with no active trials currently listed. The studies together enrolled 174 participants. ACY-1215 is investigational and has not been approved by the FDA for any indication.
Three completed Phase 1 trials have evaluated ACY-1215 in multiple myeloma: NCT02189343 with pomalidomide and dexamethasone, NCT01583283 with lenalidomide and dexamethasone, and NCT01323751 alone and with bortezomib and dexamethasone. All were conducted in the United States and enrolled adults aged 18 years and older.