Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer
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.
Checked against the public recordLast updated Dec 19, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: LDK378; Drug: AUY922
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * locally advanced or metastatic NSCLC that has progressed during or following therapy with an ALK inhibitor * 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: * central nervous system (CNS) metastases that are symptomatic or require increasing steroids or CNS-directed therapy to control CNS disease * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Colorado Dept. of Anschutz Cancer (3)Aurora, Colorado
- Massachusetts General Hospital Mass GeneralBoston, Massachusetts
- Fox Chase Cancer Center Fox Chase Cancer (2)Philadelphia, Pennsylvania
- University of Utah / Huntsman Cancer Institute HuntsmanSalt Lake City, Utah
- Novartis Investigative SiteMelbourne, Victoria
- Novartis Investigative SiteMilan, MI
- Novartis Investigative SiteSingapore
- Novartis Investigative SiteBarcelona, Catalonia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 19, 2020. Always confirm current availability with the study team.