Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel



Status:Completed
Conditions:Lung Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:September 2010
End Date:March 2013
Contact:US GSK Clinical Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

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An Open-Label, Phase I/Ib Dose Escalation Study to Assess the Safety and Tolerability of GSK1120212 in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel in Subjects With Advanced Solid Tumors


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 safety of up to 6 different GSK1120212 study treatment combinations
(GSK1120212 plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin,
pemetrexed + cisplatin, or nab-paclitaxel). The doses identified in this study may be used
in future trials to test whether the combination treatment is a safe and effective therapy
for subjects with metastatic lung and/or pancreatic cancers.


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
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Austin, Texas 78705
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Anaheim, California 92807
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Aurora, Colorado 80010
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Charleston, South Carolina 29425
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Glendale, Arizona 85304
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Kennewick, Washington 99336
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Knoxville, Tennessee 37916
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Las Vegas, Nevada 89102
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Las Vegas, NV
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New York, New York 10032
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New York, NY
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Richmond, Virginia 23298
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Richmond, VA
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