Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer
NCT01772797 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2020-12-19
Summary
The primary purpose of the study is to estimate the maximum tolerated dose of the combination of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in ALK-rearranged non-small cell lung cancer.
Conditions
- Anaplastic Lymphoma Kinase (ALK)
- Non-small Cell Lung Cancer
Interventions
- DRUG
-
LDK378
LDK378 is a capsule to be taken daily by mouth.
- DRUG
-
AUY922
AUY922 is an intravenous infusion that will be administered by the investigative site to the patient on a weekly basis.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2016-01-31
- Completion
- 2016-01-31
Countries
- United States
- Australia
- Italy
- Singapore
- Spain
Study Locations
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