This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Comparison of AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive Non Small Cell Lung Cancer (NSCLC) Patients

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: April 29, 2009
Last updated: November 9, 2016
Last verified: November 2016
The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer.

Condition Intervention Phase
Non Small Cell Lung Cancer Drug: AZD6244 Drug: docetaxel Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination With Docetaxel, Compared With Docetaxel Alone, in 2nd Line Patients With KRAS Mutation Positive Locally Advanced Metastatic Non Small Cell Lung Cancer (Stage IIIB- IV)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the efficacy in terms of Overall Survival (OS) of AZD6244 in combination with docetaxel compared with docetaxel alone, in 2nd line patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer [ Time Frame: Time Frame: Overall survival calculated as the interval from date of randomisation to date of patient death (any cause). Patients who have not died at final analysis, or who withdraw consent, will be censored at last date they were known to be alive. ]

Secondary Outcome Measures:
  • To further assess the efficacy in terms of:- Progression Free Survival (PFS) -Objective Response Rate (ORR)- Duration of Response (DoR)- Change in tumour size at 12 weeks- Alive and Progression Free at 6 months (APF6) [ Time Frame: PFS, ORR, DoR, APF6 and change in tumour size at 12 weeks will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 12 weeks thereafter relative to randomisation. ]
  • To assess the safety and tolerability profile of AZD6244 in combination with docetaxel [ Time Frame: At every visit (ie weekly for the first 6 weeks and then every 3 weeks) ]
  • To investigate the pharmacokinetics of AZD6244 [ Time Frame: At Day 1 and Day 22 ]

Enrollment: 422
Study Start Date: April 2009
Study Completion Date: November 2016
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
AZD6244 in combination with docetaxel
Drug: AZD6244
oral capsules, 75mg twice daily
Drug: docetaxel
75mg/m2 iv on day 1 of every 21 day cycle
Other Name: Taxotere
Placebo Comparator: 2
Placebo in combination with docetaxel
Drug: docetaxel
75mg/m2 iv on day 1 of every 21 day cycle
Other Name: Taxotere
Drug: Placebo


Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Locally advanced or metastatic non small cell lung cancer (IIIB-IV)
  • Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy
  • Tumour sample confirmed as KRAS mutation positive (Note: Sample must be available upon enrolment to ship to AZ appointed central laboratory, or mutation status confirmed locally at AstraZeneca agreed local laboratory using agreed methodology, or mutation status confirmed by an accredited (eg CLIA certified) commercial laboratory (eg Genzyme or Lab 21).

Exclusion Criteria:

  • Received >1 prior anti-cancer therapy for advanced or metastatic non small cell lung cancer (excluding radiotherapy)
  • Prior treatment with a MEK inhibitor or any docetaxel containing regimen (prior treatment with paclitaxel is acceptable)
  • Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug
  • Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00890825

  Hide Study Locations
United States, California
Research Site
Los Angeles, California, United States
United States, Colorado
Research Site
Aurora, Colorado, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, Ohio
Research Site
Columbus, Ohio, United States
Research Site
Brussels (Jette), Belgium
Research Site
Charleroi, Belgium
Research Site
Edegem, Belgium
Research Site
Leuven, Belgium
Research Site
Liege, Belgium
Research Site
Liège, Belgium
Research Site
Belo Horizonte, Brazil
Research Site
Ijuí, Brazil
Research Site
Porto Alegre, Brazil
Research Site
Rio de Janeiro, Brazil
Research Site
Santo André, Brazil
Research Site
Sao Paulo, Brazil
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Canada, Ontario
Research Site
Oshawa, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Czech Republic
Research Site
Ostrava, Czech Republic
Research Site
Praha 8, Czech Republic
Research Site
Znojmo, Czech Republic
Research Site
Brest Cedex, France
Research Site
Clermont Ferrand, France
Research Site
Dijon, France
Research Site
Lyon Cedex 08, France
Research Site
Marseille, France
Research Site
Rennes, France
Research Site
Budapest, Hungary
Research Site
Györ, Hungary
Research Site
Mosdós, Hungary
Research Site
Székesfehérvár, Hungary
Research Site
Törökbálint, Hungary
Research Site
Bologna, Italy
Research Site
Genova, Italy
Research Site
Milano, Italy
Research Site
Orbassano, Italy
Research Site
Perugia, Italy
Research Site
Roma, Italy
Research Site
Rozzano, Italy
Research Site
Mexico, Mexico
Research Site
Morelia, Mexico
Research Site
Zacatecas, Mexico
Research Site
Lima, Peru
Research Site
A Coruña, Spain
Research Site
Badalona(Barcelona), Spain
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
Research Site
Málaga, Spain
Sponsors and Collaborators
Principal Investigator: Dr Pasi Janne Dana-Farber Cancer Institute, Boston, USA
Study Director: Gabriella Mariani AstraZeneca, Hertfordshire, UK
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00890825     History of Changes
Other Study ID Numbers: D1532C00016
Study First Received: April 29, 2009
Last Updated: November 9, 2016

Keywords provided by AstraZeneca:
Non small cell lung cancer (NSCLC)
KRAS mutation

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017