Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01192165 |
Recruitment Status :
Completed
First Posted : August 31, 2010
Last Update Posted : November 13, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer | Drug: Trametinib (GSK1120212) Drug: Docetaxel Drug: Erlotinib Drug: Pemetrexed Drug: Carboplatin Drug: nab-Paclitaxel Drug: Cisplatin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 169 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | September 14, 2010 |
Actual Primary Completion Date : | October 7, 2013 |
Actual Study Completion Date : | October 7, 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment Group 1
Trametinib plus Docetaxel
|
Drug: Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor) Drug: Docetaxel Chemotherapy |
Experimental: Treatment Group 2
Trametinib plus Erlotinib
|
Drug: Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor) Drug: Erlotinib Small molecule targeted therapy (EGFR inhibitor) |
Experimental: Treatment Group 3
Trametinib plus Pemetrexed
|
Drug: Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor) Drug: Pemetrexed Chemotherapy |
Experimental: Treatment Group 4
Trametinib plus Pemetrexed and Carboplatin
|
Drug: Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor) Drug: Pemetrexed Chemotherapy Drug: Carboplatin Chemotherapy |
Experimental: Treatment Group 5
Trametinib plus nab-Paclitaxel
|
Drug: Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor) Drug: nab-Paclitaxel Chemotherapy |
Experimental: Treatment Group 6
Trametinib plus Pemetrexed and Cisplatin
|
Drug: Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor) Drug: Pemetrexed Chemotherapy Drug: Cisplatin Chemotherapy |
- To determine the safety, tolerability, and recommended phase II dosing regimen of each GSK1120212-based treatment combination [ Time Frame: Duration of study (approximately 3 years) ]
- To characterize population pharmacokinetic parameters [ Time Frame: Duration of study (approximately 3 years) ]
- To evaluate the anti-tumor activity as assessed by tumor response rate according to RECIST v1.1 [ Time Frame: Duration of study (approximately 3 years) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192165
United States, Arizona | |
GSK Investigational Site | |
Scottsdale, Arizona, United States, 85259 | |
United States, California | |
GSK Investigational Site | |
Duarte, California, United States, 91010 | |
GSK Investigational Site | |
Sacramento, California, United States, 95817 | |
United States, Colorado | |
GSK Investigational Site | |
Denver, Colorado, United States, 80218 | |
United States, Nevada | |
GSK Investigational Site | |
Las Vegas, Nevada, United States, 89169 | |
United States, New York | |
GSK Investigational Site | |
Albany, New York, United States, 12206 | |
United States, South Carolina | |
GSK Investigational Site | |
Greenville, South Carolina, United States, 29605 | |
United States, Tennessee | |
GSK Investigational Site | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
GSK Investigational Site | |
Dallas, Texas, United States, 75246 | |
GSK Investigational Site | |
Houston, Texas, United States, 77030 | |
GSK Investigational Site | |
Tyler, Texas, United States, 75702 | |
United States, Virginia | |
GSK Investigational Site | |
Norfolk, Virginia, United States, 23502 | |
United States, Washington | |
GSK Investigational Site | |
Vancouver, Washington, United States, 98684 | |
Canada, Ontario | |
GSK Investigational Site | |
Toronto, Ontario, Canada, M5G 2M9 | |
France | |
GSK Investigational Site | |
Caen Cedex 9, France, 14033 | |
GSK Investigational Site | |
Marseille cedex 5, France, 13385 | |
GSK Investigational Site | |
Saint-Herblain cedex, France, 44805 | |
GSK Investigational Site | |
Toulouse cedex, France, 31052 | |
Korea, Republic of | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 120-752 | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 135-710 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01192165 |
Other Study ID Numbers: |
113486 2012-000257-32 ( EudraCT Number ) |
First Posted: | August 31, 2010 Key Record Dates |
Last Update Posted: | November 13, 2017 |
Last Verified: | November 2017 |
Taxotere Cisplatin Carboplatin Trametinib GSK1120212 Tarceva KRAS |
Pemetrexed MEK inhibitor nab-Paclitaxel Docetaxel Alimta Abraxane Erlotinib |
Paclitaxel Docetaxel Carboplatin Pemetrexed Erlotinib Hydrochloride Trametinib Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors |