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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
University of Colorado Dept. of Anschutz Cancer (3)
Aurora, Colorado, United States
Massachusetts General Hospital Mass General
Boston, Massachusetts, United States
Fox Chase Cancer Center Fox Chase Cancer (2)
Philadelphia, Pennsylvania, United States
University of Utah / Huntsman Cancer Institute Huntsman
Incidence rate of Dose Limiting Toxicities (DLT)
cycle = within the first 28 days of patient's first dose
Time frame: up to day 28 after the patient's first dose
Number of patients with adverse events
Characterize the safety and tolerability of LDK378 and AUY922 in patients
Time frame: 30 months
Changes in laboratory values
Characterize the safety and tolerability of LDK378 and AUY922 in patients
Time frame: 30 months
Assessments of electrocardiograms
Characterize the safety and tolerability of LDK378 and AUY922 in patients
Time frame: 30 months
Assessments of dose interruptions, reductions, and dose intensity
Characterize the safety and tolerability of LDK378 and AUY922 in patients
Time frame: 30 months
Plasma PK parameter of LDK378 and AUY922: Tmax
Characterize single and multiple dose PK of LDK378 and AUY922 in patients
Time frame: 30 months
Overall response rate (ORR)
Assess the anti-tumor activity of LDK378 and AUY922
Time frame: 30 months
Duration of Response (DoR)
Assess the anti-tumor activity of LDK378 and AUY922
Time frame: 30 months
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Salt Lake City, Utah, United States
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Barcelona, Catalonia, Spain
Time to Response (TTR)
Assess the anti-tumor activity of LDK378 and AUY922
Time frame: 30 months
Progression free survival (PFS)
Assess the anti-tumor activity of LDK378 and AUY922 per RECIST 1.1
Time frame: 30 months
Number of patients with serious adverse events
Characterize the safety and tolerability of LDK378 and AUY922 in patients
Time frame: 30 months
Plasma PK parameter of LDK378 and AUY922: Cmax
Characterize single and multiple dose PK of LDK378 and AUY922 in patients
Time frame: 30 months
Plasma PK parameter of LDK378 and AUY922: AUClast
Characterize single and multiple dose PK of LDK378 and AUY922 in patients
Time frame: 30 months
Plasma PK parameter of LDK378 and AUY922: AUCtau
Characterize single and multiple dose PK of LDK378 and AUY922 in patients
Time frame: 30 months
Plasma PK parameter of LDK378 and AUY922: Cmin
Characterize single and multiple dose PK of LDK378 and AUY922 in patients
Time frame: 30 months
Plasma PK parameter of LDK378 and AUY922: Racc
Characterize single and multiple dose PK of LDK378 and AUY922 in patients
Time frame: 30 months