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Active (not recruiting) Phase 1 NCT02393625

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

Phase 1 – testing safety in a small group of people
Conditions: ALK-positive NSCLC

Sponsor: Novartis Pharmaceuticals

trial.available_in: БГ
Overview
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
Who can participate
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
Locations 8
Australia (1)
Novartis Investigative Site
Heidelberg , Victoria
Belgium (1)
Novartis Investigative Site
Leuven , Vlaams Brabant
Canada (1)
Novartis Investigative Site
Toronto , Ontario
Hong Kong (1)
Novartis Investigative Site
Hong Kong
Italy (1)
Novartis Investigative Site
Milan , MI
Singapore (1)
Novartis Investigative Site
Singapore
Spain (1)
Novartis Investigative Site
Barcelona
United States (1)
Mayo Clinic - Arizona
Scottsdale , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
27.05.2015
Completion date
09.04.2027
Registry ID
NCT02393625
Source
anzctr
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