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Active (not recruiting) Phase 3 NCT01933932

Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

Phase 3 – large-scale trial before approval
Conditions: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel
Description
A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)
Who can participate
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) * KRAS mutation positive tumour sample as determined by the designated testing 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. * Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment * Other concomitant anti-cancer therapy agents excepts steroids * Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable). * Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment
Locations 24
Argentina (1)
Research Site
Buenos Aires
Australia (1)
Research Site
Camperdown
Belgium (1)
Research Site
Brussels
Brazil (1)
Research Site
Barretos
Bulgaria (1)
Research Site
Plovdiv
Canada (1)
Research Site
Edmonton , Alberta
Chile (1)
Research Site
Santiago
France (1)
Research Site
Brest
Germany (1)
Research Site
Augsburg
Hungary (1)
Research Site
Budapest
Israel (1)
Research Site
Beersheba
Italy (1)
Research Site
Bari
Mexico (1)
Research Site
México
Netherlands (1)
Research Site
's-Hertogenbosch
Peru (1)
Research Site
Lima
Poland (1)
Research Site
Brzozów
Romania (1)
Research Site
Cluj-Napoca
Russia (1)
Research Site
Kazan'
Spain (1)
Research Site
Barcelona
Sweden (1)
Research Site
Linköping
Turkey (1)
Research Site
Ankara
Ukraine (1)
Research Site
Chernivtsі
United Kingdom (1)
Research Site
Aberdeen
United States (1)
Research Site
Aurora , Colorado
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
130 Years
Healthy volunteers
No
Start date
25.09.2013
Completion date
31.12.2025
Registry ID
NCT01933932
Source
anzctr
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