Pacritinib in Patients With Endothelial Growth Factor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC) After EGFR Tyrosine Kinase Inhibitor (TKI)

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT02342353
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

Study Details

The goal of the study is to find the best dose of pacritinib when given in combination with erlotinib.

Key Dates

Start date
May 18, 2015
Status verified
Feb 2018
Primary completion
Feb 6, 2018
Completion
Feb 6, 2018

Study Design

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

Arms

  • Experimental: Phase I (pacritinib and erlotinib)
    * Pacritinib will be administered orally twice a day; dosing will depend on the dose level the patient is enrolled. * Erlotinib will be taken by mouth on an outpatient basis daily at a dose of 150 mg. * A 28-day interval is defined as a cycle
  • Experimental: Phase II (pacritinib and erlotinib)
    * Pacritinib will be administered orally twice a day; the dose used will be the dose determined to be the MTD in phase I. * Erlotinib will be taken by mouth on an outpatient basis daily at a dose of 150 mg. * A 28-day interval is defined as a cycle

Primary Outcome Measure

Dose-limiting toxicities and maximum tolerated dose (MTD) - Phase I only [ Time Frame: Completion of cycle 1 of all Phase I patients (estimated to be 1 year) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Washington University School of Medicine· St Louis, MO

Related Studies