Platine Duyarlı Yumurtalık Kanseri Hastalarında Niraparib ile Plasebonun İdame Tedavisi Olarak Karşılaştırılması

Sade dilde özet

Bu çalışma, platin tedavisine duyarlı yumurtalık, fallop tüpü veya periton kanseri hastalarında Niraparib ilacını idame (sürdürme) tedavisi olarak plaseboyla karşılaştırıyor. Yüksek dereceli seröz veya BRCA mutasyonu olan, son platin tedavisine yanıt vermiş hastalar dahil edilmiştir. Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Tamamlandı

Sponsor

Tesaro, Inc.

Müdahale

Active comparator: Niraparib, placebo

Başlangıç

21.06.2013

Tahmini bitiş

26.12.2021

Ülkeler

United States, Austria, Belgium, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Norway, Poland, Spain, Sweden, United Kingdom

İlgili genler

Merkezler

• Phoenix, United States
• Tucson, United States
• Los Angeles, United States
• Los Angeles, United States
• Palo Alto, United States
• San Francisco, United States
• New Haven, United States
• Sarasota, United States
• Tampa, United States
• Atlanta, United States
• Chicago, United States
• Indianapolis, United States
• Indianapolis, United States
• Boston, United States
• Boston, United States
• Burlington, United States
• Minneapolis, United States
• Minneapolis, United States
• Rochester, United States
• Morristown, United States
• Farmington, United States
• Lake Success, United States
• New York, United States
• New York, United States
• Durham, United States
• Oklahoma City, United States
• Vancouver, United States
• Abington, United States
• Philadelphia, United States
• Providence, United States
• Nashville, United States
• Austin, United States
• Dallas, United States
• Fort Worth, United States
• The Woodlands, United States
• Graz, Austria
• Innsbruck, Austria
• Vienna, Austria
• Edegem, Belgium
• Kortrijk, Belgium

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Uygunluk kriterleri

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

Inclusion Criteria:

* 18 years of age or older, female, any race
* Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
* High grade (or grade 3) serous histology or known to have gBRCAmut
* Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease)
* Has responded to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
* ECOG 0-1
* Adequate bone marrow, kidney and liver function

Exclusion Criteria:

* Known hypersensitivity to the components of niraparib
* Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
* Symptomatic uncontrolled brain metastasis
* Is pregnant or breast feeding
* Immunocompromised patients
* Known active hepatic disease
* Prior treatment with a known PARP inhibitor