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
10
sites
Charleston, South Carolina 29425
2422
mi
from 98109
Charleston, SC
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Anaheim, California 92807
981
mi
from 98109
Anaheim, CA
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Aurora, Colorado 80010
1026
mi
from 98109
Aurora, CO
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Austin, Texas 78705
1769
mi
from 98109
Austin, TX
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Glendale, Arizona 85304
1104
mi
from 98109
Glendale, AZ
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Kennewick, Washington 99336
179
mi
from 98109
Kennewick, WA
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Knoxville, Tennessee 37916
2110
mi
from 98109
Knoxville, TN
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Las Vegas, Nevada 89102
874
mi
from 98109
Las Vegas, NV
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New York, New York 10032
2400
mi
from 98109
New York, NY
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Richmond, Virginia 23298
2352
mi
from 98109
Richmond, VA
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