NCT01911507

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

Phase I Study of INC280 Plus Erlotinib in Patients With C-Met Expressing Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of INC280 (c-Met inhibitor INCB028060) plus erlotinib (erlotinib hydrochloride) in patients with met proto-oncogene (MET) expressing non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To describe the toxicity profile of INC280 plus erlotinib. II. To determine the preliminary efficacy of INC280 plus erlotinib. III. To characterize the pharmacokinetic behavior of this combination. TERTIARY OBJECTIVES: I. To collect blood and tumor samples for exploratory analysis of the MET and epidermal growth factor receptor (EGFR) signaling pathways. OUTLINE: This is a dose-escalation study. Patients receive c-Met inhibitor INCB028060 orally (PO) twice daily (BID) and erlotinib hydrochloride PO once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Recurrent Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	INC280	Given PO
DRUG	erlotinib hydrochloride	Given PO

Timeline

• Start date: 2013-08-27
• Primary completion: 2020-08-26
• Completion: 2020-08-26
• First posted: 2013-07-30
• Last updated: 2021-10-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study