Phase I Study of LXH254 in Patients With Advanced Solid Tumors Haboring MAPK Pathway Alterations

A Phase I Dose Finding Study of Oral LXH254 in Adult Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations

ClinicalTrials.gov Identifier: NCT02607813

Novartis Reference Number: CLXH254X2101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

A Phase I Study of LXH254 in Patients With Advanced Solid Tumors That Harbor MAPK Pathway Alterations.

Condition 
NSCLC
Ovarian Cancer
Melanoma
Other Solid Tumors
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
152 participants
Start date 
Jan 18, 2016
Completion date 
Mar 03, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
LXH254
pan-RAF inhibitor
Drug
PDR001
Biological: PDR001 anti-PD1 antibody

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

- Prior treatment with a BRAFi, MEKi and/or pan-RAF inihibitors for patients to be enrolled in the dose expansion part.

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

Additional exclusion criteria for LXH254 in combination with PDR001

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.

Other inclusion/exclusion criteria as per protocol may apply.

Study Locations

United States
Massachusetts General Hospital MGH Cancer Center
Active, not recruiting
Boston, 02114
Massachusetts
United States
Memorial Sloan Kettering Cancer Center SC - LXH254X2101
Recruiting
New York, 10065
New York
United States
UT M.D Anderson Cancer Center SC - LXH254X2101
Recruiting
Houston, 77030
Texas
United States
Canada
Novartis Investigative Site
Active, not recruiting
Toronto, M5G 2C1
Ontario
Canada
France
Novartis Investigative Site
Recruiting
Paris, 75010
-
France
Novartis Investigative Site
Recruiting
Toulouse, 31059
-
France
Germany
Novartis Investigative Site
Withdrawn
Essen, 45147
-
Germany
Novartis Investigative Site
Completed
Heidelberg, 69120
-
Germany
Italy
Novartis Investigative Site
Recruiting
Milano, 20133
MI
Italy
Novartis Investigative Site
Recruiting
Modena, 41124
MO
Italy
Novartis Investigative Site
Recruiting
Napoli, 80131
-
Italy
Japan
Novartis Investigative Site
Active, not recruiting
Chuo ku, 104 0045
Tokyo
Japan
Korea, Republic of
Novartis Investigative Site
Active, not recruiting
Seoul, 03080
-
Korea, Republic of
Netherlands
Novartis Investigative Site
Recruiting
Groningen, 9713 GZ
-
Netherlands
Medical Oncology, Erasmus MC
Recruiting
Rotterdam, 3075 CE
-
Netherlands
Spain
Novartis Investigative Site
Completed
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Active, not recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Active, not recruiting
Madrid, 28046
-
Spain
Switzerland
Novartis Investigative Site
Active, not recruiting
Zuerich, 8091
-
Switzerland

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]