Clinical Trial VICCTHN1379
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)
- Protocol No. VICCTHN1379
- Open Date: 02/21/2014
- Staging: Phase III
- Age Group: Adults
- Scope: National
- Objective: To assess the efficacy in terms of Progression Free Survival (PFS) of selumetinib in combination with docetaxel compared to placebo in combination with docetaxel.
- Disease Sites: Lung
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Docetaxel; Docetaxel (Taxotere); G-CSF; Selumetinib
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01933932
- Secondary Protocol No: D1532C00079
Patients are being asked to take part in this research study because they have been given a diagnosis of a specific type of lung cancer called -non-small cell lung cancer- (NSCLC). The study is being carried out to see if a new cancer treatment, selumetinib in combination with an established chemotherapy (docetaxel) is more effective than the chemotherapy on its own.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• 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
• 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 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 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