Itacitinib in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations

Part of paid clinical trials in Ogden, Utah.

Sponsor
Incyte Corporation
Study ID
NCT02355431
Phase
PHASE2
Status
Withdrawn

Conditions

  • NSCLC (Non-small Cell Lung Carcinoma)
  • Solid Tumors and Hematologic Malignancy

Eligibility Criteria

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

Interventions

  • Itacitinib — DRUG
    tablets to be administered by mouth once daily at dose selected from safety run-in phase
  • erlotinib — DRUG
    150 mg tablets administered by mouth once daily at total daily dose of 150 mg
  • placebo — DRUG
    matching placebo tablets to be administered by mouth at dose selected from safety run-in phase

Study Details

The purpose of this study is to determine if Itacitinib in combination with erlotinib is safe and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB/Stage IV or recurrent whose tumors have EGFR activating mutations.

Key Dates

Start date
Dec 31, 2014
Status verified
Mar 2019
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Itacitinib plus erlotinib
  • Active Comparator: Placebo plus erlotinib

Primary Outcome Measure

Part 1: Determination of the dose of itacitinib that is safe and tolerable in combination with erlotinib as measured by the number of dose-limiting toxicities (DLTs) observed in the evaluation cohort. [ Time Frame: Baseline through Day 21 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-OgdenUtah--

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