Education and Training

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