Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel
NCT ID: NCT01192165
Last Updated: 2017-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
169 participants
INTERVENTIONAL
2010-09-14
2013-10-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group 1
Trametinib plus Docetaxel
Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor)
Docetaxel
Chemotherapy
Treatment Group 2
Trametinib plus Erlotinib
Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor)
Erlotinib
Small molecule targeted therapy (EGFR inhibitor)
Treatment Group 3
Trametinib plus Pemetrexed
Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor)
Pemetrexed
Chemotherapy
Treatment Group 4
Trametinib plus Pemetrexed and Carboplatin
Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor)
Pemetrexed
Chemotherapy
Carboplatin
Chemotherapy
Treatment Group 5
Trametinib plus nab-Paclitaxel
Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor)
nab-Paclitaxel
Chemotherapy
Treatment Group 6
Trametinib plus Pemetrexed and Cisplatin
Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor)
Pemetrexed
Chemotherapy
Cisplatin
Chemotherapy
Interventions
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Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor)
Docetaxel
Chemotherapy
Erlotinib
Small molecule targeted therapy (EGFR inhibitor)
Pemetrexed
Chemotherapy
Carboplatin
Chemotherapy
nab-Paclitaxel
Chemotherapy
Cisplatin
Chemotherapy
Eligibility Criteria
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Inclusion Criteria
* Tumor progression following at least one prior standard therapy, the subject refuses standard therapy, or no standard therapy exists.
* The subject has a radiographically measurable tumor.
* The subject is able to carry out daily life activities without difficulty.
* The subject is able to swallow and retain oral medication.
* The subject does not have significant side effects from previous anti-cancer treatment.
* The subject has adequate organ and blood cell counts.
* Sexually active subjects must use medically acceptable methods of contraception during the course of the study.
Exclusion Criteria
* The subject has a brain tumor.
* Current severe, uncontrolled systemic disease.
* History of clinically significant heart, lung, or eye/vision problems.
* The subject has high blood pressure that is not well-controlled with medication.
* The subject has a permanent pacemaker.
* The subject is pregnant or breastfeeding.
* Positive for Hepatitis B, Hepatitis C, or HIV.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Duarte, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Albany, New York, United States
GSK Investigational Site
Greenville, South Carolina, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Tyler, Texas, United States
GSK Investigational Site
Norfolk, Virginia, United States
GSK Investigational Site
Vancouver, Washington, United States
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Caen, , France
GSK Investigational Site
Marseille, , France
GSK Investigational Site
Saint-Herblain, , France
GSK Investigational Site
Toulouse, , France
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
Countries
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References
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Gandara DR, Leighl N, Delord JP, Barlesi F, Bennouna J, Zalcman G, Infante JR, Reckamp KL, Kelly K, Shepherd FA, Mazieres J, Janku F, Gardner OS, Mookerjee B, Wu Y, Cox DS, Schramek D, Peddareddigari V, Liu Y, D'Amelio AM Jr, Blumenschein G Jr. A Phase 1/1b Study Evaluating Trametinib Plus Docetaxel or Pemetrexed in Patients With Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2017 Mar;12(3):556-566. doi: 10.1016/j.jtho.2016.11.2218. Epub 2016 Nov 19.
Other Identifiers
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2012-000257-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
113486
Identifier Type: -
Identifier Source: org_study_id