FGFR1 Yeniden Düzenlenmesi Olan Miyeloid/Lenfoid Neoplazmlı Kişilerde Pemigatinib (INCB054828) Etkililik ve Güvenlilik Çalışması (FIGHT-203)

Sade dilde özet

Bu çalışma, FGFR1 geninde yeniden düzenlenme (rearrangement) bulunan miyeloid ya da lenfoid neoplazm (myeloid/lymphoid neoplasm, bir tür kan hücresi kanseri) olan kişilerde Pemigatinib ilacının etkililiğini ve güvenliliğini değerlendirmektedir. Çalışmaya, kök hücre nakli ya da diğer tedavilerden sonra nüks etmiş veya bu tedavilere uygun olmayan hastalar alınmıştır. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

Incyte Corporation

Müdahale

Pemigatinib

Başlangıç

25.04.2017

Tahmini bitiş

30.10.2024

Ülkeler

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

İlgili genler

Merkezler

• 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

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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.