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
- INC280 — DRUGGiven PO
- erlotinib hydrochloride — DRUGGiven PO
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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, Davis | Sacramento | California | 95817 | - |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | - |
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