Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
Adil Daud
Photo of Adil Daud
Adil Daud

Description

Summary

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

Official Title

A Phase Ib, Open-label, Multicenter Study of Oral LXH254-centric Combinations in Adult Patients With Advanced or Metastatic KRAS or BRAF Mutant Non-Small Cell Lung Cancer or NRAS Mutant Melanoma

Keywords

Non-Small Cell Lung Cancer Melanoma NSCLC NRAS KRAS BRAF LXH254 LTT462 Trametinib Ribocliclib Non-small cell lung carcinoma (NSCLC) treatment of lung cancer after first metastasis lung cancer lung adenocarcinoma Large-cell lung carcinoma Non small cell lung carcinoma Non small cell lung cancer Large cell lung carcinoma Large cell lung cancer squamous cell lung carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung Ribociclib LXH254+LTT462 LXH254+Trametinib LXH254+Ribociclib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Other protocol-defined inclusion/exclusion criteria may apply

Locations

  • Novartis Investigative Site accepting new patients
    San Francisco California 94143 United States
  • Novartis Investigative Site accepting new patients
    San Diego California 92103 United States

Lead Scientist at UCSF

  • Adil Daud
    Professor, Medicine. Authored (or co-authored) 163 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT02974725
Phase
Phase 1
Study Type
Interventional
Last Updated