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An Open-label Study of GSK1120212 Compared With Docetaxel in Stage IV KRAS-mutant Non-small Cell Lung Cancer

NCT ID: NCT01362296

Last Updated: 2014-07-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-09-30

Brief Summary

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This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and safety of GSK1120212 compared with docetaxel in the second line setting for subjects with locally advanced or metastatic (Stage IV) Non-small cell lung cancer (NSCLC) harboring a KRAS mutation who have failed one platinum-containing chemotherapy regimen. A small subset of NSCLC subjects harboring BRAF, NRAS, or MEK1 mutations will be randomized in addition to the primary KRAS population, for exploratory purposes.

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Detailed Description

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Conditions

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Lung Cancer, Non-Small Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GSK1120212

Oral once daily

Group Type EXPERIMENTAL

GSK1120212

Intervention Type DRUG

Oral once daily

docetaxel

IV once every 3 weeks

Group Type ACTIVE_COMPARATOR

docetaxel

Intervention Type DRUG

IV once every 3 weeks

Interventions

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GSK1120212

Oral once daily

Intervention Type DRUG

docetaxel

IV once every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old with histologically- or cytologically-confirmed diagnosis of adenocarcinoma Stage IV NSCLC with a positive mutational status for the KRAS, NRAS, BRAF, or MEK1 gene.
* Documented tumor progression after receiving at least one, but not more than one, prior approved platinum-containing chemotherapy regimen for advanced stage/metastatic NSCLC.
* Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
* Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
* Life expectancy of at least three months in the opinion of the investigator.
* Women of childbearing potential must have a negative serum pregnancy test within 14 days of randomization to study treatment and agree to use effective contraception. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from the time of randomization to study medication until at least four weeks after the last dose of study treatment.
* Adequate baseline organ function.

Exclusion Criteria

* History of another malignancy.
* Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
* Treatment with a BRAF or MEK inhibitor or docetaxel as monotherapy or as part of a combination regimen.
* Anti-cancer therapy (including chemotherapy and radiation therapy) within the last three weeks.
* History or current evidence / risk of retinal vein occlusion or central serous retinopathy.
* Any current or history of tumor manifestation in the Central Nervous System.
* History or evidence of cardiovascular risk, including QTcB \>=480 msec, uncontrolled arrhythmias, acute coronary syndrome, coronary angioplasty, or stenting within 6 months prior to randomization, \>=Class II congestive heart failure, treatment refractory hypertension, intra-cardiac defibrillators or permanent pacemakers or cardiac metastases.
* Known Human Immunodeficiency Virus, Hepatitis B Virus (HBV), or Hepatitis C Virus (HBC) infection (with the exception of chronic or cleared HBV and HCV infection).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Scottsdale, Arizona, United States

Site Status

GSK Investigational Site

Orange, California, United States

Site Status

GSK Investigational Site

Aurora, Colorado, United States

Site Status

GSK Investigational Site

Jacksonville, Florida, United States

Site Status

GSK Investigational Site

Athens, Georgia, United States

Site Status

GSK Investigational Site

Coeur d'Alene, Idaho, United States

Site Status

GSK Investigational Site

Indianapolis, Indiana, United States

Site Status

GSK Investigational Site

Baltimore, Maryland, United States

Site Status

GSK Investigational Site

Boston, Massachusetts, United States

Site Status

GSK Investigational Site

Boston, Massachusetts, United States

Site Status

GSK Investigational Site

Detroit, Michigan, United States

Site Status

GSK Investigational Site

Minneapolis, Minnesota, United States

Site Status

GSK Investigational Site

Rochester, Minnesota, United States

Site Status

GSK Investigational Site

St Louis, Missouri, United States

Site Status

GSK Investigational Site

Lebanon, New Hampshire, United States

Site Status

GSK Investigational Site

Durham, North Carolina, United States

Site Status

GSK Investigational Site

Columbus, Ohio, United States

Site Status

GSK Investigational Site

Portland, Oregon, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

Memphis, Tennessee, United States

Site Status

GSK Investigational Site

Austin, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Fairfax, Virginia, United States

Site Status

GSK Investigational Site

Vancouver, Washington, United States

Site Status

GSK Investigational Site

Marseille, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Strasbourg, , France

Site Status

GSK Investigational Site

Toulouse, , France

Site Status

GSK Investigational Site

Villejuif, , France

Site Status

GSK Investigational Site

Athens, , Greece

Site Status

GSK Investigational Site

Athens, , Greece

Site Status

GSK Investigational Site

Heraklion, Crete, , Greece

Site Status

GSK Investigational Site

Neo Faliro, , Greece

Site Status

GSK Investigational Site

Thessaloniki, , Greece

Site Status

GSK Investigational Site

Budapest, , Hungary

Site Status

GSK Investigational Site

Székesfehérvár, , Hungary

Site Status

GSK Investigational Site

Törökbálint, , Hungary

Site Status

GSK Investigational Site

Genoa, Liguria, Italy

Site Status

GSK Investigational Site

Milan, Lombardy, Italy

Site Status

GSK Investigational Site

Milan, Lombardy, Italy

Site Status

GSK Investigational Site

Amsterdam, , Netherlands

Site Status

GSK Investigational Site

Amsterdam, , Netherlands

Site Status

GSK Investigational Site

Breda, , Netherlands

Site Status

GSK Investigational Site

Groningen, , Netherlands

Site Status

GSK Investigational Site

Maastricht, , Netherlands

Site Status

GSK Investigational Site

Zwolle, , Netherlands

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Badalona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Majadahonda (Madrid), , Spain

Site Status

GSK Investigational Site

Pamplona, , Spain

Site Status

Countries

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United States France Greece Hungary Italy Netherlands South Korea Spain

References

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Blumenschein GR Jr, Smit EF, Planchard D, Kim DW, Cadranel J, De Pas T, Dunphy F, Udud K, Ahn MJ, Hanna NH, Kim JH, Mazieres J, Kim SW, Baas P, Rappold E, Redhu S, Puski A, Wu FS, Janne PA. A randomized phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212) compared with docetaxel in KRAS-mutant advanced non-small-cell lung cancer (NSCLC)dagger. Ann Oncol. 2015 May;26(5):894-901. doi: 10.1093/annonc/mdv072. Epub 2015 Feb 26.

Reference Type DERIVED
PMID: 25722381 (View on PubMed)

Other Identifiers

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114653

Identifier Type: -

Identifier Source: org_study_id

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