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INCB057643 · 1 trial · 7 indications
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with ruxolitinib.
| Arm | Type | Description |
|---|---|---|
| Part 1 : INCB057643 Monotherapy | EXPERIMENTAL | INCB057643 dose escalation and dose expansion |
| Part 2 : INCB057643 Combination with Ruxolitinib | EXPERIMENTAL | Combination arm in dose escalation and dose expansion |
| Name | Type | Description |
|---|---|---|
| INCB057643 | DRUG | INCB057643 dose escalation and dose expansion. |
| Ruxolitinib | DRUG | Ruxolitinib will be administered twice a day using the dose described for each Cohort in the protocol for Part 2. |
Inclusion Criteria: * Age 18 years and older at the time of signing the informed consent. * Part 1 Monotherapy: Participants with confirmed diagnosis of relapsed or refractory MF (primary, or post-PV and post-ET), MDS, MDS/MPN, or ET who have received at least 1 prior line of therapy; are either re...
INCB057643 is an investigational small molecule being developed by Incyte Corporation for myelofibrosis and other advanced myeloid neoplasms. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in a single active clinical trial.
INCB057643 is being studied for the treatment of myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis. The Phase 1 trial also enrolls patients with myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm overlap syndrome, and other myeloproliferative neoplasms.
INCB057643 is being developed by Incyte Corporation, which trades on the Nasdaq under the ticker symbol INCY. Incyte is the sponsor of the Phase 1 clinical trial evaluating the drug in patients with myelofibrosis and related myeloid neoplasms.
INCB057643 is in Phase 1 clinical development. It is an investigational agent and has not received FDA approval. The single ongoing trial is a Phase 1 safety and tolerability study that is currently active but not recruiting participants.
INCB057643 is being evaluated in one clinical trial, NCT04279847, titled a safety and tolerability study in participants with myelofibrosis and other advanced myeloid neoplasms. The trial is Phase 1, active but not recruiting, and has an estimated enrollment of 140 participants across the United States, Canada, China, Finland, Italy, Japan, Spain, and the United Kingdom.
The NCT04279847 trial enrolls adults 18 years and older of any sex with myelofibrosis or other advanced myeloid neoplasms, including myelodysplastic syndrome and myeloproliferative neoplasms. Healthy volunteers are not eligible. The study is controlled but is not randomized or double blinded.