INC280 and Erlotinib Hydrochloride in Treating Patients With Non-small Cell Lung Cancer

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT01911507
Phase
PHASE1
Status
Completed

Conditions

  • Recurrent Non-small Cell Lung Cancer

Eligibility Criteria

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

Interventions

Study Details

This phase I trial studies the side effects and best dose of c-Met inhibitor INCB028060 and erlotinib hydrochloride when given together in treating patients with previously treated non-small cell lung cancer. C-Met inhibitor INCB028060 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

First listed
Jul 30, 2013
Start date
Aug 27, 2013
Status verified
Sep 2021
Primary completion
Aug 26, 2020
Completion
Aug 26, 2020

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment ( INCB028, erlotinib)
    Patients receive INC280 PO BID and erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose (MTD) of c-Met inhibitor INCB028060 and erlotinib, determined according to incidence of dose-limiting toxicity (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V4 [ Time Frame: Up to 28 days after a full course of therapy ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95817-
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94115-

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