Clinical Trials /

Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.

NCT01750281

Description:

The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.
  • Official Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: D1532C00064
  • SECONDARY ID: 2012-003622-25
  • NCT ID: NCT01750281

Conditions

  • Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Interventions

DrugSynonymsArms
Selumetinib 75 mgSelumetinib 75 mg twice daily +Docetaxel 75 mg/m2
Docetaxel 75 mg/m2Selumetinib 75 mg twice daily +Docetaxel 75 mg/m2
Docetaxel 60 mg/m2Selumetinib 75 mg twice daily + Docetaxel 60 mg/m2
PlaceboPlacebo twice daily + Docetaxel 75 mg/m2

Purpose

The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients

Detailed Description

      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)
    

Trial Arms

NameTypeDescriptionInterventions
Selumetinib 75 mg twice daily +Docetaxel 75 mg/m2ExperimentalSelumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
  • Selumetinib 75 mg
  • Docetaxel 75 mg/m2
Selumetinib 75 mg twice daily + Docetaxel 60 mg/m2ExperimentalSelumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 60 mg/m2 intravenously administered on day 1 of each 21 day cycle.
  • Selumetinib 75 mg
  • Docetaxel 60 mg/m2
Placebo twice daily + Docetaxel 75 mg/m2ExperimentalThree placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
  • Docetaxel 75 mg/m2
  • Placebo

Eligibility Criteria

        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)

          -  Prospective confirmation of KRAS mutation negative status as determined via an AZ
             approved laboratory

          -  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.

          -  Other concomitant anti-cancer therapy agents except steroids

          -  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.
      
Maximum Eligible Age:130 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Baseline and then every 6 weeks after randomization until objective disease progression, up to 29 months (at the time of the analysis)
Safety Issue:
Description:Median time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours (RECIST v1.1): >= 20% increase in the sum of diameters of Target Lesions (TL) and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of Non TLs or a new lesion.

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Following progression, survival status was collected every 8 weeks until death, withdrawal of consent, or end of study, whichever occurred first, up to 29 months (at the time of the analysis)
Safety Issue:
Description:The time from randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:AstraZeneca

Trial Keywords

  • Mitogen-Activated Protein Kinase Kinase inhibitor
  • Non Small Cell Lung Cancer
  • Metastatic
  • Second line treatment for Non Small Cell Lung Cancer

Last Updated