Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02292550
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ribociclib — DRUG
    CDK 4/6 inhibitor
  • Ceritinib — DRUG
    ALK inhibitor

Study Details

This was a Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer. The purpose of the study was to determine the MTD/RP2D of the LEE011 and ceritinib combination and evaluate whether the combination was safe and had beneficial effects in ALK-positive advanced non-small cell lung cancer patients. This trial did not progress to Phase II. Trial population terminated before reaching Phase II

Key Dates

Start date
May 14, 2015
Status verified
Jul 2019
Primary completion
Sep 26, 2018
Completion
Sep 26, 2018

Study Design

Enrollment
27 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ribociclib 100 mg + Ceritinib 300 mg
    LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use
  • Experimental: Ribociclib 100 mg + Ceritinib 450 mg
    LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use
  • Experimental: Ribociclib 200 mg + Ceritinib 300 mg
    LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use
  • Experimental: Ribociclib 200 mg + Ceritinib 450 mg
    LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use
  • Experimental: Ribociclib 300 mg + Ceritinib 450 mg
    LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use

Primary Outcome Measure

Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase Ib ) [ Time Frame: 1 month ]

Locations (1)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Novartis Investigative Site· Boston, MA

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