Metastatik Kolorektal Kanserde Cetuximab ile MEN1611 (C-PRECISE-01)

Sade dilde özet

Bu çalışma, metastatik kolorektal kanser (metastatic colorectal cancer) hastalarında MEN1611 adlı ilacı Cetuximab ile birlikte incelemiştir. Daha önce irinotecan, oxaliplatin, 5-FU ve anti-EGFR içeren tedaviler görmüş, RAS/BRAF yabani tip ve PIK3CA mutasyonlu hastalar katılıma uygundur. Çalışma Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

PHASE1/PHASE2

Durum

Tamamlandı

Sponsor

Menarini Group

Müdahale

MEN1611, Cetuximab

Başlangıç

20.07.2020

Tahmini bitiş

27.02.2024

Ülkeler

United States, France, Germany, Italy, Netherlands, Poland, Spain

İlgili genler

Merkezler

• Phoenix, United States
• Anaheim, United States
• Tacoma, United States
• Angers, France
• Dijon, France
• Saint-Herblain, France
• Berlin, Germany
• Dresden, Germany
• Hamburg, Germany
• Munich, Germany
• Munich, Germany
• Tübingen, Germany
• Genoa, Italy
• Milan, Italy
• Milan, Italy
• Pisa, Italy
• Rozzano, Italy
• Amsterdam, Netherlands
• Maastricht, Netherlands
• Nijmegen, Netherlands
• Rotterdam, Netherlands
• Skórzewo, Poland
• Warsaw, Poland
• Barcelona, Spain
• Madrid, Spain
• Madrid, Spain
• Madrid, Spain
• Valencia, Spain

Uygunluk kriterleri

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

Main Inclusion Criteria:

* Histological documentation of adenocarcinoma of the colon or rectum.
* Progression or recurrence following prior irinotecan, oxaliplatin, 5-fluorouracil (5-FU) and anti-epidermal growth factor receptor (EGFR) containing regimens for metastatic disease.
* Best response according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria to the last anti-EGFR containing regimen of partial response or stable disease for at least 4 months.
* Measurable disease according to RECIST criteria.
* N-K-RAS (exons 2, 3 and 4) and BRAF wild-type and PIK3CA mutated.
* Eastern Cooperative Oncology Group performance status of 0 or 1.

Main Exclusion Criteria:

* Previous treatment with PI3K inhibitor.
* Brain metastases, unless treated \>4 weeks before screening visit and only if clinically stable and not receiving corticosteroids.
* National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Grade ≥2 diarrhea.
* History of significant, uncontrolled or active cardiovascular disease.
* Known active or uncontrolled pulmonary dysfunction.
* Uncontrolled diabetes mellitus (glycated hemoglobin \>7%) and fasting plasma glucose \>126 milligrams/deciliter.
* Known history of human immunodeficiency virus infection or active infection with hepatitis C virus or hepatitis B virus.
* Concurrent chronic immunosuppressive treatment either with steroids or other immunosuppressive agents.