Status:
COMPLETED
Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel
Lead Sponsor:
GlaxoSmithKline
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine what dose of GSK1120212 can be given safely in combination with at least one other drug that is already approved to treat cancer. This study will test the saf...
Eligibility Criteria
Inclusion
- The subject has a solid tumor. Expansion cohorts are limited to non-small cell lung cancer and/or pancreatic cancer with or without a KRAS mutation.
- 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
- The subject has had major surgery or received certain types of cancer therapy within 2-3 weeks before starting the study.
- 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.
Key Trial Info
Start Date :
September 14 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2013
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT01192165
Start Date
September 14 2010
End Date
October 7 2013
Last Update
November 13 2017
Active Locations (20)
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1
GSK Investigational Site
Scottsdale, Arizona, United States, 85259
2
GSK Investigational Site
Duarte, California, United States, 91010
3
GSK Investigational Site
Sacramento, California, United States, 95817
4
GSK Investigational Site
Denver, Colorado, United States, 80218