İleri Solid Kötü Huylu Tümörü Olan Erişkin Hastalarda Doz Artırma Çalışması

Sade dilde özet

Bu çalışma, FGFR1 veya FGFR2 gen amplifikasyonu ya da FGFR3 mutasyonu taşıyan, standart tedavisi kalmamış ileri solid (katı) tümörü olan hastalarda BGJ398 adlı ilacı artan dozlarda inceliyor. Doğrulanmış ileri tümörü olan hastalar dahil edilmiştir. Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Tamamlandı

Sponsor

Novartis Pharmaceuticals

Müdahale

BGJ398

Başlangıç

11.12.2009

Tahmini bitiş

08.10.2018

Ülkeler

United States, Australia, Austria, France, Germany, Israel, Italy, Netherlands, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye)

İlgili genler

Merkezler

• Duarte, United States
• Los Angeles, United States
• Los Angeles, United States
• Aurora, United States
• New Haven, United States
• Boston, United States
• Detroit, United States
• New York, United States
• New York, United States
• Columbus, United States
• Philadelphia, United States
• Philadelphia, United States
• Pittsburgh, United States
• Memphis, United States
• Nashville, United States
• Salt Lake City, United States
• Heidelberg, Australia
• Vienna, Austria
• Bordeaux, France
• Lyon, France
• Marseille, France
• Montpellier, France
• Paris, France
• Saint-Herblain Cédex, France
• Suresnes, France
• Toulouse, France
• Villejuif, France
• Cologne, Germany
• Essen, Germany
• Hanover, Germany
• Marburg, Germany
• Ramat Gan, Israel
• Tel Aviv, Israel
• Meldola, Italy
• Amsterdam, Netherlands
• Amsterdam, Netherlands
• Singapore, Singapore
• Seoul, South Korea
• Seoul, South Korea
• Seville, Spain

+10

Uygunluk kriterleri

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

Inclusion Criteria:

* Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists
* Adequate bone marrow function
* Adequate hepatic and renal function
* Adequate cardiovascular function
* Contraception.

  * For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.
  * For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period

Exclusion Criteria:

* Patients with primary CNS tumor or CNS tumor involvement
* Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
* History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification
* Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination.
* History or current evidence of cardiac arrhythmia and/or conduction abnormality
* Women who are pregnant or nursing.

Other protocol-defined inclusion/exclusion criteria may apply