Study of LXH254 and LTT462 in NSCLC

Description

To characterize safety and tolerability of LXH254 and LTT462 combination and identify a recommended dose and regimen.

Study Start Date

February, 24 2017

Estimated Completion Date

December 2018

Interventions

  • Drug: LXH254
  • Drug: LTT462

Study ID

Novartis -- CLXH254X2102

Status

Unknown

Trial ID

NCT02974725

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

75

Sponsor

Novartis

Inclusion Criteria

  • Patients must have advanced or metastatic NSCLC
  • Presence of KRAS or BRAF mutation 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
  • Group 1: Prior treatment with a RAFi (including any BRAFi and pan-RAFi), MEKi and/or ERKi. Group 2: 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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Massachusetts General Hospital SC - Boston, Massachusetts 2.8 miles Bakhan Barzangy 617-726-1849 bbarzangy@mgh.harvard.edu
Massachusetts General Hospital SC - Boston, Massachusetts 2.8 miles Bakhan Barzangy 617-726-1849 bbarzangy@mgh.harvard.edu

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.