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

  • STATUS
    Recruiting
Updated on 14 December 2020
Investigator
Incyte Corporation Call Center
Primary Contact
Institut Universitaire du Cancer de Toulouse - Oncopole (0.0 mi away) Contact
+34 other location
FGFR1
lymphoid malignancy
myeloid neoplasm

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
Clinical Study IdentifierTX247348
Last Modified on14 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women, aged 18 or older
Documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study
Only subjects who are not candidates for stem cell transplantation, or have relapsed after stem cell transplantation and delayed lymphocyte infusion and who have progressed and are not candidates for other disease-modifying therapies are eligible for the study. All relapsed/refractory subjects must have evidence of either cytogenetic or hematological disease and have no evidence of residual toxicity (eg, graft-versus-host disease requiring treatment)
Life expectancy ≥ 12 weeks
ECOG performance status 0 to 2

Exclusion Criteria

Prior receipt of a selective FGFR inhibitor
History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues (exception: commonly observed calcifications in soft tissues, such as the skin, kidney, tendons, or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance)
Current evidence of clinically significant corneal disorder/keratopathy (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis, etc) or retinal disorder (including but not limited to macular/retinal degeneration, diabetic retinopathy, retinal detachment, etc) as confirmed by ophthalmologic examination
Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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