A Phase I/IB Trial of MEK162 in Combination With Erlotinib in NSCLC Harboring KRAS or EGFR Mutation
NCT01859026 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43
Last updated 2023-01-19
Summary
The main purpose of this study is to find out if the drugs MEK162 and erlotinib (Tarceva) given in combination are safe and have beneficial effects in patients who have NSCLC.
The U.S. Food and Drug Administration (FDA) has not approved MEK162 for use to treat NSCLC. Erlotinib is an FDA approved drug for the treatment of Non-Small Cell Lung Cancer.
Conditions
Interventions
- DRUG
-
MEK162
Treatment as outlined in study arms.
- DRUG
-
Erlotinib
Treatment as outlined in study arms.
Sponsors & Collaborators
-
Array BioPharma
collaborator INDUSTRY -
H. Lee Moffitt Cancer Center and Research Institute
lead OTHER
Principal Investigators
-
Jhanelle Gray, M.D. · H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-30
- Primary Completion
- 2019-08-22
- Completion
- 2019-08-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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