Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer
NCT ID: NCT01772797
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2013-06-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LDK378 and AUY922
LDK378
LDK378 is a capsule to be taken daily by mouth.
AUY922
AUY922 is an intravenous infusion that will be administered by the investigative site to the patient on a weekly basis.
Interventions
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LDK378
LDK378 is a capsule to be taken daily by mouth.
AUY922
AUY922 is an intravenous infusion that will be administered by the investigative site to the patient on a weekly basis.
Eligibility Criteria
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Inclusion Criteria
* tumor must carry an ALK rearrangement in 15% or more of tumor cells as measured by FISH
* disease that can be evaluated by RECIST v1.1 and measurable disease
Exclusion Criteria
* history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
* clinically significant cardiac dysfunction
* inadequate end organ function as defined by specified laboratory values
* use of medications known to be strong inhibitors or inducters of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment
* use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that cannot be discontinued at least 1 week prior to start of treatment
* clinically significant, uncontrolled impaired gastrointestinal function or GI disease
* prior treatment with a HSP90 inhibitor
* radiotherapy to lung within 4 weeks prior to the first dose of study treatment or patients who have not recovered from radiotherapy-related toxicities
* pregnant or nursing women
* history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
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
Countries
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Related Links
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Results for CLDK378X2102 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2012-004632-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLDK378X2102
Identifier Type: -
Identifier Source: org_study_id