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

Plain-language summary

This study evaluates the efficacy and safety of the drug Pemigatinib in people with a myeloid or lymphoid neoplasm (a type of blood cell cancer) that has an FGFR1 gene rearrangement. It enrolled patients who had relapsed after stem cell transplantation or other therapies, or who were not candidates for them. The study was carried out in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Incyte Corporation

Intervention

Pemigatinib

Start date

4/25/2017

Estimated completion

10/30/2024

Countries

United States, Austria, Belgium, Canada, France, Germany, Italy, Japan, Spain, Switzerland, United Kingdom

Related genes

Locations

• Phoenix, United States
• Duarte, United States
• Stanford, United States
• Atlanta, United States
• Indianapolis, United States
• St Louis, United States
• New York, United States
• Houston, United States
• Salt Lake City, United States
• Linz, Austria
• Vienna, Austria
• Vienna, Austria
• Leuven, Belgium
• Toronto, Canada
• Lyon, France
• Nice, France
• Paris, France
• Toulouse, France
• Aachen, Germany
• Halle, Germany
• Jena, Germany
• Leipzig, Germany
• Mannheim, Germany
• Minden, Germany
• Bergamo, Italy
• Florence, Italy
• Osaka, Japan
• Tokyo, Japan
• Valencia, Spain
• Bern, Switzerland
• Zurich, Switzerland
• London, United Kingdom
• Oxford, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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.