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A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, Compared With Placebo in Combination With Docetaxel, in Patients Receiving Second Line Treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

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Trial Information

A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, Compared With Placebo in Combination With Docetaxel, in Patients Receiving Second Line Treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)


A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and
Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel,
Compared with Placebo in Combination with Docetaxel, in Patients receiving second line
treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)


Inclusion Criteria:



- Provision of signed, written and dated informed consent prior to any study specific
procedures

- Male or female, aged 18 years or older

- Histological or cytological confirmation of locally advanced or metastatic NSCLC
(IIIB-IV)

- Adequate tumour sample available for assessment of KRAS mutation status (via an AZ
approved laboratory or locally laboratory) and additional tumour biomarkers

- Failure of 1st line anti-cancer therapy due to radiological documentation of disease
progression in advanced disease or subsequent relapse of disease following 1st line
therapy

Exclusion Criteria:

- Mixed small cell and non-small cell lung cancer histology

- Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients
who develop disease progression while on switch maintenance therapy (maintenance
using an agent not in the first-line regimen) will not be eligible.

- Any systemic anti-cancer therapy within 4 weeks prior to starting study treatment (6
weeks for nitrosoureas, mitomycin, and suramin) or any anti-cancer therapy which has
not been cleared from the body by the time of starting study treatment.

- Prior treatment with a MEK (Mitogen-Activated Protein Kinase) inhibitor or any
docetaxel-containing regimen (prior treatment with paclitaxel is acceptable)

- The last radiation therapy within 4 weeks prior to starting study treatment, or
limited field of radiation for palliation within 7 days of the first dose of study
treatment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression).

Outcome Time Frame:

Measured at baseline until the date of first documented objective disease progression, assessed up to 16 months.

Safety Issue:

No

Principal Investigator

Ian Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

AstraZeneca UK, MSD

Authority:

United States: Food and Drug Administration

Study ID:

D1532C00064

NCT ID:

NCT01750281

Start Date:

December 2012

Completion Date:

July 2014

Related Keywords:

  • Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
  • Mitogen-Activated Protein Kinase Kinase inhibitor
  • Non Small Cell Lung Cancer
  • Metastatic
  • Second line treatment for Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteBaton Rouge, Louisiana  
Research SiteBeverly, Massachusetts  
Research SiteAlbany, New York  
Research SiteAllentown, Pennsylvania