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

Part of paid clinical trials in San Diego, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02974725
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LXH254 — DRUG
    LXH254 will be supplied as tablet for oral use.
  • LTT462 — DRUG
    LTT462 will be supplied as hard gelatin capsule for oral use.
  • Trametinib — DRUG
    Trametinib will be supplied as film-coated tablet for oral use
  • Ribociclib — DRUG
    Ribociclib will be supplied in tablets and hard gelatin capsules.

Study Details

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

Key Dates

Start date
Feb 24, 2017
Status verified
Apr 2025
Primary completion
Apr 24, 2024
Completion
Apr 24, 2024

Study Design

Enrollment
241 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LXH254+LTT462
  • Experimental: LXH254+Trametinib
  • Experimental: LXH254+Ribociclib

Primary Outcome Measure

Number of participants with Adverse Events (AEs) as a measure of safety and tolerability [ Time Frame: up to 5 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of California San Diego .San DiegoCalifornia92103-
UCSF Medical CenterSan FranciscoCalifornia94143-
Massachusetts General Hospital SCBostonMassachusetts02114-
Memorial Sloan Kettering Cancer Ctr .New YorkNew York10065-
Sarah Cannon Research Institute Tennessee OncologyNashvilleTennessee37203-
Uni of TX MD Anderson Cancer CntrHoustonTexas77030-

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