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A Phase II, Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of GSK1120212 Compared With Docetaxel in 2nd Line Subjects With Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC Stage IV)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Non-Small Cell

Thank you

Trial Information

A Phase II, Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of GSK1120212 Compared With Docetaxel in 2nd Line Subjects With Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC Stage IV)


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS) as assessed by the investigator (INV)

Outcome Description:

PFS is defined as the time from RAN until the earliest date of documented radiological PD or DT due to any cause. PD was assessed by the INV according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. PD is defined as at least a 20% increase in the sum of the diameters (SD) of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. For participants (PAR) who did not have a documented date of PD or DT, PFS was censored at the date of the last adequate assessment. For PAR who received subsequent anti-cancer therapy prior to the date of documented PD or DT, PFS was censored at the date of the last adequate assessment prior to the initiation of therapy.

Outcome Time Frame:

From randomization (RAN) until the earliest date of documented radiological disease progression (PD) or death (DT) due to any cause (maximum of 10.2 months)

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

114653

NCT ID:

NCT01362296

Start Date:

September 2011

Completion Date:

November 2013

Related Keywords:

  • Lung Cancer, Non-Small Cell
  • NRAS
  • docetaxel
  • NSCLC
  • GSK1120212
  • MEK inhibitor
  • targeted therapy
  • KRAS
  • BRAF
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SiteHooksett, New Hampshire  03106
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteCoeur d'Alene, Idaho  83814
GSK Investigational SiteOregon City, Oregon  97045
GSK Investigational SiteSeattle, Washington  98133