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Активно (без набиране) Фаза 1 NCT02393625

Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: ALK-positive NSCLC

Спонсор: Novartis Pharmaceuticals

Налично на: БГ
Обобщение
This is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in ALK-positive NSCLC patients
Кой може да участва
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of NSCLC that carries an ALK rearrangement * Stage IIIB or IV NSCLC or relapsed locally advanced or metastatic NSCLC * Presence of at least one measurable lesion as defined by RECIST 1.1 * Patients who have received prior chemotherapy, other ALK inhibitors, biologic therapy, or other investigational agents, must have recovered from all toxicities related to prior anticancer therapies to grade ≤1 (CTCAE v 4.03). Patients with grade ≤ 2 peripheral neuropathy or any grade of alopecia, fatigue, nail changes or skin changes are allowed to enter the study * Patient has a WHO performance status 0-1 Exclusion Criteria: * Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years * Patients with an active, known or suspected autoimmune disease * Unable or unwilling to swallow tablets or capsules * Patient has other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the opinion of the Investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study results
Места на провеждане 8
Австралия (1)
Novartis Investigative Site
Heidelberg , Victoria
Белгия (1)
Novartis Investigative Site
Leuven , Vlaams Brabant
Канада (1)
Novartis Investigative Site
Toronto , Ontario
Hong Kong (1)
Novartis Investigative Site
Hong Kong
Италия (1)
Novartis Investigative Site
Milan , MI
Сингапур (1)
Novartis Investigative Site
Singapore
Испания (1)
Novartis Investigative Site
Barcelona
САЩ (1)
Mayo Clinic - Arizona
Scottsdale , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
100 Years
Здрави доброволци
Не
Начална дата
27.05.2015
Крайна дата
09.04.2027
Регистрационен номер
NCT02393625
Източник
anzctr
Запитване за медицински туризъм

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