A Phase I Dose Finding Study of Oral LXH254 in Adult Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations
Status: Terminated
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
A Phase I Study of LXH254 in Patients With Advanced Solid Tumors That Harbor MAPK Pathway Alterations.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• All patients participating in this clinical trial must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or appropriate.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Presence of at least one measurable lesion according to RECIST v1.1.
• Documented MAPK alteration
⁃ Additional inclusion criteria for the Dose Expansion part: LXH254 in combination with PDR001:
• Patients with confirmed KRAS-mutated NSCLC
• Patients with confirmed NRAS-mutated melanoma (cutaneous melanoma only)
Locations
United States
Massachusetts
Massachusetts General Hospital MGH Cancer Center
Boston
New York
Memorial Sloan Kettering Cancer Center SC - LXH254X2101
New York
Texas
UT M.D Anderson Cancer Center SC - LXH254X2101
Houston
Other Locations
Canada
Novartis Investigative Site
Toronto
France
Novartis Investigative Site
Paris Cedex 10
Novartis Investigative Site
Toulouse
Germany
Novartis Investigative Site
Heidelberg
Italy
Novartis Investigative Site
Milano
Novartis Investigative Site
Modena
Novartis Investigative Site
Napoli
Japan
Novartis Investigative Site
Chuo Ku
Netherlands
Novartis Investigative Site
Groningen
Medical Oncology, Erasmus MC
Rotterdam
Republic of Korea
Novartis Investigative Site
Seoul
Spain
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Madrid
Novartis Investigative Site
Madrid
Switzerland
Novartis Investigative Site
Zuerich
Time Frame
Start Date: 2016-01-18
Completion Date: 2022-02-19
Participants
Target number of participants: 142
Treatments
Experimental: Dose escalation LXH254
Experimental: Dose expansion LXH254: Group 1
Experimental: Dose expansion LXH254: Group 2
Experimental: Dose expansion LXH254: Group 3
Experimental: Dose expansion: LXH254 + PDR001
Experimental: Dose escalation LXH254 + PDR001
Authors
Sponsors
Leads: Novartis Pharmaceuticals