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

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ClinicalTrials.gov Identifier: NCT01192165

Recruitment Status : Completed

First Posted : August 31, 2010

Last Update Posted : November 13, 2017

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

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 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.

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 Design

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin Paclitaxel Carboplatin Docetaxel Pemetrexed Erlotinib Trametinib

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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) ]

Secondary Outcome Measures :

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) ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

Results for study 113486 can be found on the GSK Clinical Study Register. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01192165 History of Changes
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

Keywords provided by GlaxoSmithKline:


Taxotere Cisplatin Carboplatin Trametinib GSK1120212 Tarceva KRAS	Pemetrexed MEK inhibitor nab-Paclitaxel Docetaxel Alimta Abraxane Erlotinib

Additional relevant MeSH terms:

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Paclitaxel Docetaxel Albumin-Bound Paclitaxel Cisplatin Carboplatin Erlotinib Hydrochloride Pemetrexed Trametinib Antineoplastic Agents, Phytogenic	Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

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