Phase I Study of LXH254 in Patients With Advanced Solid Tumors Haboring MAPK Pathway Alterations
NCT ID: NCT02607813
Last Updated: 2022-12-21
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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TERMINATED
PHASE1
142 participants
INTERVENTIONAL
2016-01-18
2022-02-19
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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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose escalation LXH254
LXH254
pan-RAF inhibitor
Dose expansion LXH254: Group 1
LXH254
pan-RAF inhibitor
Dose expansion LXH254: Group 2
LXH254
pan-RAF inhibitor
Dose expansion LXH254: Group 3
LXH254
pan-RAF inhibitor
Dose expansion: LXH254 + PDR001
LXH254
pan-RAF inhibitor
PDR001
Biological: PDR001 anti-PD1 antibody
Dose escalation LXH254 + PDR001
LXH254
pan-RAF inhibitor
PDR001
Biological: PDR001 anti-PD1 antibody
Interventions
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LXH254
pan-RAF inhibitor
PDR001
Biological: PDR001 anti-PD1 antibody
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
* Presence of at least one measurable lesion according to RECIST v1.1.
* Documented MAPK alteration
* Patients with confirmed KRAS-mutated NSCLC
* Patients with confirmed NRAS-mutated melanoma (cutaneous melanoma only)
Exclusion Criteria
Exceptions may be made after documented agreement between Novartis and Investigator.
* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
* Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
* Patients receiving proton pump inhibitors which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
* Pregnant or nursing (lactating) women
* History of severe hypersensitivity reactions, which in the opinion of the investigator may cause in increased risk of serious infusion reaction.
* Known human immunodeficiency virus (HIV).
* Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
* Active, known or suspected autoimmune disease.
* Active infection requiring systemic antibiotic therapy
* Patients requiring systemic steroid therapy or any immunosuppressive therapy (≥10mg/day prednisone or equivalent) which cannot be discontinued at least 7 days prior to first dose of study treatment.
* Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
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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Massachusetts General Hospital MGH Cancer Center
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center SC - LXH254X2101
New York, New York, United States
UT M.D Anderson Cancer Center SC - LXH254X2101
Houston, Texas, United States
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Modena, MO, Italy
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Chuo Ku, Tokyo, Japan
Novartis Investigative Site
Groningen, , Netherlands
Medical Oncology, Erasmus MC
Rotterdam, , Netherlands
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Zurich, , Switzerland
Countries
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Related Links
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Other Identifiers
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2015-003421-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLXH254X2101
Identifier Type: -
Identifier Source: org_study_id