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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000257-32 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental | Trametinib plus Docetaxel |
|
| Treatment Group 2 | Experimental | Trametinib plus Erlotinib |
|
| Treatment Group 3 | Experimental | Trametinib plus Pemetrexed |
|
| Treatment Group 4 | Experimental | Trametinib plus Pemetrexed and Carboplatin |
|
| Treatment Group 5 | Experimental | Trametinib plus nab-Paclitaxel |
|
| Treatment Group 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trametinib (GSK1120212) | Drug | Investigational small molecule targeted therapy (MEK1/2 inhibitor) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety, tolerability, and recommended phase II dosing regimen of each GSK1120212-based treatment combination | Duration of study (approximately 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize population pharmacokinetic parameters | Duration of study (approximately 3 years) | |
| To evaluate the anti-tumor activity as assessed by tumor response rate according to RECIST v1.1 | Duration of study (approximately 3 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Scottsdale | Arizona | 85259 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27876675 | Derived | 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. |
| Label | URL |
|---|---|
| Results for study 113486 can be found on the GSK Clinical Study Register. | View source |
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Trametinib plus Pemetrexed and Cisplatin
|
| Docetaxel | Drug | Chemotherapy |
|
| Erlotinib | Drug | Small molecule targeted therapy (EGFR inhibitor) |
|
| Pemetrexed | Drug | Chemotherapy |
|
| Carboplatin | Drug | Chemotherapy |
|
| nab-Paclitaxel | Drug | Chemotherapy |
|
| Cisplatin | Drug | Chemotherapy |
|
| Duarte |
| California |
| 91010 |
| United States |
| GSK Investigational Site | Sacramento | California | 95817 | United States |
| GSK Investigational Site | Denver | Colorado | 80218 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89169 | United States |
| GSK Investigational Site | Albany | New York | 12206 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29605 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Tyler | Texas | 75702 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23502 | United States |
| GSK Investigational Site | Vancouver | Washington | 98684 | United States |
| GSK Investigational Site | Toronto | Ontario | M5G 2M9 | Canada |
| GSK Investigational Site | Caen | 14033 | France |
| GSK Investigational Site | Marseille | 13385 | France |
| GSK Investigational Site | Saint-Herblain | 44805 | France |
| GSK Investigational Site | Toulouse | 31052 | France |
| GSK Investigational Site | Seoul | 120-752 | South Korea |
| GSK Investigational Site | Seoul | 135-710 | South Korea |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C560077 | trametinib |
| D000077143 | Docetaxel |
| D000069347 | Erlotinib Hydrochloride |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| C520255 | 130-nm albumin-bound paclitaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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