A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement
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- STATUS
- Recruiting
Summary
This is an open-label, monotherapy study of INCB054828 in subjects with myeloid/lymphoid neoplasms with FGFR1 rearrangement.
Subjects will receive a once daily (QD) dose of INCB054828 at 13.5 mg on a 2-week-on–therapy and 1-week-off–therapy schedule.
With Protocol Amendment 3, the administration schedule will be adjusted, and newly enrolled subjects will receive INCB054828 at 13.5 mg continuous administration (no planned dose hold).
Subjects receiving treatment under previous versions of the Protocol may be switched to continuous administration after completing at least 3 cycles if there are no ongoing Grade 2 or higher related TEAEs. The written request to switch to continuous administration should be sent to the sponsor's medical monitor.
Description
- All potential subjects must have documentation of an 8p11 translocation known to activate FGFR1 through the site's own cytogenetics laboratory.
- Once documentation has been provided, the subject will then undergo screening to meet the rest of the inclusion/exclusion criteria.
- Once a subject has completed screening and has enrolled into the study, treatment will start on Cycle 1 Day 1.
- Subjects will undergo regular safety assessments during treatment as well as regular efficacy assessments.
- Subjects will be allowed to continue administration in 21-day cycles until loss of benefit from therapy or unacceptable toxicity is reported.
Details
| Condition | Neoplasms, Myeloid/Lymphoid Neoplasms FGFR1 rearrangement, Myeloid Neoplasms FGFR1 rearrangement, Lymphoid Neoplasms FGFR1 rearrangement, FGFR1 rearrangement, Lymphoid Neoplasms, Myeloid Neoplasms |
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| Clinical Study Identifier | TX247348 |
| Last Modified on | 19 December 2022 |
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