Clinical Trials /

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

NCT02974725

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of LXH254 and LTT462 in NSCLC
  • Official Title: A Phase Ib, Open-label, Multicenter Study of Oral LXH254 in Combination With Oral LTT462 in Adult Patients With Advanced or Metastatic KRAS or BRAF Mutant Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: CLXH254X2102
  • SECONDARY ID: 2016-004293-18
  • NCT ID: NCT02974725

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
LXH254LXH254+LTT462
LTT462LXH254+LTT462

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
LXH254+LTT462Experimental
  • LXH254
  • LTT462

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with Adverse Events (AEs) as a measure of safety and tolerability
Time Frame:12 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Duration of response (DOR)
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Disease Control Rate (DCR)
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Progression Free Survival (PFS)
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Overall Survival (OS) - (dose expansion part only)
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Plasma concentrations of LXH254
Time Frame:Up to Month 5
Safety Issue:
Description:
Measure:Plasma concentrations of LTT462
Time Frame:Up to Month 5
Safety Issue:
Description:
Measure:Derived PK parameter (Cmax) for LXH254 & LTT462:
Time Frame:Up to Month 5
Safety Issue:
Description:
Measure:Derived PK parameter (AUC) for LXH254 & LTT462
Time Frame:Up to Month 5
Safety Issue:
Description:
Measure:Changes from baseline of pharmacodynamics (PD) marker DUSP6 in tumor samples
Time Frame:baseline, month 12
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • NSCLC
  • KRAS
  • BRAF
  • LXH254
  • LTT462
  • 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

Last Updated

September 22, 2017