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A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma

Trial Status: Active

To characterize safety and tolerability and identify a recommended dose and regimen for the LXH254 in combination with LTT462 or trametinib or ribociclib.

Inclusion Criteria

  • Patients must have advanced or metastatic NSCLC or cutaneous melanoma
  • Presence of KRAS or BRAF mutation (NSCLC) or NRAS mutation (cutaneous melanoma) in tumor tissue
  • All patients participating in this clinical trial must have progressed following standard therapy or, in the opinion of the Investigator, no effective standard therapy exists, is tolerated, appropriate or is considered equivalent to study treatment.
  • ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2

Exclusion Criteria

  • Dose expansion - KRAS or NRAS mutant patients groups: Prior treatment with a RAFi (including any BRAFi and pan-RAFi), MEKi and/or ERKi. BRAF mutant patients group: Prior treatment with an ERKi and/or a pan-RAFi.
  • 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 (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
  • Patients with Gilbert's syndrome or other heritable diseases of bile processing.

California

San Diego
University of California San Diego
Status: ACTIVE
San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: APPROVED

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: WITHDRAWN

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Novartis Pharmaceuticals Corporation

  • Primary ID CLXH254X2102
  • Secondary IDs NCI-2017-02021, 2016-004293-18
  • Clinicaltrials.gov ID NCT02974725