Tümörlerinde Normalden Fazla HER2 Geni Kopyası Bulunan Hastalarda Trastuzumab ve Pertuzumab'ın Test Edilmesi (MATCH - Alt Protokol J)

Sade dilde özet

Bu çalışma, tümörlerinde HER2 geninin normalden fazla kopyasını (HER2 amplifikasyonu) taşıyan hastalarda Trastuzumab ve Pertuzumab ilaçlarının etkisini incelemektedir. NCI-MATCH ana protokolü kapsamında HER2 amplifikasyonu saptanan, meme, mide ve kolorektal kanser dışındaki tümörlere sahip hastalar değerlendirilmektedir. Çalışma Faz 2 aşamasında yürütülmekte; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).

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

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Devam ediyor, katılım kapalı

Sponsor

National Cancer Institute (NCI)

Müdahale

Biopsy Procedure, Biospecimen Collection, Echocardiography Test, Pertuzumab, Radiologic Examination, Trastuzumab

Başlangıç

23.03.2017

Tahmini bitiş

15.01.2027

Ülkeler

United States

İlgili genler

Merkezler

• Philadelphia, United States

Uygunluk kriterleri

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

Inclusion Criteria:

* Patients must have met applicable eligibility criteria in the Master MATCH Protocol EAY131/ NCI-2015-00054 prior to registration to treatment subprotocol
* Patients must fulfill all eligibility criteria outlined the MATCH Master Protocol at the time of registration to treatment step (step 1, 3, 5, 7)
* Patients must have HER2 amplification, or another aberration, as determined via the MATCH Master Protocol
* Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
* Patients must have ECHO or multigated acquisition scan (MUGA) within 4 weeks prior to treatment assignment and must not have a left ventricular ejection fraction (LVEF) \< institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be \>= 50% for the patient to be eligible
* Patients must not have breast cancer, gastric/gastroesophageal junction (GEJ)/esophageal adenocarcinoma or mixed histology, gastric/GEJ not otherwise specified (NOS) tumors, or colorectal adenocarcinoma
* Patients must not have known hypersensitivity to trastuzumab or pertuzumab or compounds of similar chemical or biologic composition
* Patients must not have received prior anti-HER2 therapies, including trastuzumab, pertuzumab, trastuzumab emtansine (T-DM1), lapatinib, afatinib, neratinib, dacomitinib, canertinib
* Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use adequate contraception (hormonal or double barrier method of birth control, abstinence) from one week prior to study treatment starting, during treatment, and for a period of 7 months after the last dose of study treatment