A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)

The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • drug: Pemigatinib

Eligibility


Inclusion Criteria:

   - 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.

   - Eligible subjects must:

      - Have relapsed after stem cell transplantation or after other disease modifying
      therapy, OR

      - Not be current candidates for stem cell transplantation or other disease
      modifying therapies.

   - Note: 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.

   - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

   - Prior receipt of a selective FGFR inhibitor.

   - History and/or current evidence of ectopic mineralization/calcification, including but
   not limited to soft tissue, kidneys, intestine, myocardia, or lung, except calcified
   lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.

   - Current evidence of corneal disorder/keratopathy, including but not limited to
   bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and
   keratoconjunctivitis, 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Justin Abuel
650-723-1367
Not Recruiting

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.