AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive NSCLC Patients
Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 in Combination With Docetaxel, Compared With Docetaxel Alone, in 2nd Line Patients With KRAS Mutation Positive Locally Advanced Metastatic NSCLC
1 other identifier
interventional
88
12 countries
63
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2009
Longer than P75 for phase_2
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2009
CompletedFirst Submitted
Initial submission to the registry
April 29, 2009
CompletedFirst Posted
Study publicly available on registry
April 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2016
CompletedResults Posted
Study results publicly available
June 20, 2018
CompletedJune 20, 2018
May 1, 2018
2.1 years
April 29, 2009
June 14, 2017
May 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
OS was calculated as the interval from the date of randomisation to the date of patient death (any cause). Patients who had not died at the time of the final analysis, or who withdrew consent, were censored at the last date the patient was known to be alive.
At least 12 months since start of treatment.
Secondary Outcomes (6)
Progression Free Survival
At least 12 months after start of treatment
Objective Response Rate
At least 12 months after start of treatment
Duration of Response
At least 12 months after start of treatment
Change From Baseline in Tumour Size at 6 Week.
6 weeks after first dose of treatment
Change From Baseline in Tumour Size at Week 12
12 weeks
- +1 more secondary outcomes
Study Arms (2)
AZD6244 + Docetaxel
ACTIVE COMPARATORAZD6244 75 mg bd + Docetaxel 75 mg/m\^2
Placebo + Docetaxel
PLACEBO COMPARATORPlacebo + Docetaxel 75 mg/m\^2
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (63)
Research Site
Los Angeles, California, 90095, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Boston, Massachusetts, 02115, United States
Research Site
Columbus, Ohio, 43210, United States
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Brussels, 1090, Belgium
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Charleroi, 6000, Belgium
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Edegem, 2650, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Liège, B-4000, Belgium
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Belo Horizonte, 30180-090, Brazil
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Ijuí, 98700-000, Brazil
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Porto Alegre, 90610-000, Brazil
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Rio de Janeiro, 20230-130, Brazil
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Santo André, 09060-650, Brazil
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São Paulo, 01221-020, Brazil
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São Paulo, 04023-062, Brazil
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São Paulo, 04530-001, Brazil
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Plovdiv, 4000, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1756, Bulgaria
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Sofia, 1784, Bulgaria
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Varna, 9010, Bulgaria
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Oshawa, Ontario, L1G 2B9, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Ostrava, 708 52, Czechia
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Prague, 180 81, Czechia
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Znojmo, 669 02, Czechia
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Brest, 29609, France
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Clermont-Ferrand, 63003, France
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Dijon, 21034, France
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Lyon, 69373, France
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Marseille, 13015, France
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Rennes, 35033, France
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Budapest, 1032, Hungary
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Budapest, 1121, Hungary
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Budapest, 1122, Hungary
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Budapest, 1125, Hungary
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Győr, 9024, Hungary
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Mosdós, 7257, Hungary
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Székesfehérvár, 8000, Hungary
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Törökbálint, 2045, Hungary
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Bologna, 40131, Italy
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Genova, 16100, Italy
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Milan, 20162, Italy
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Orbassano, 10043, Italy
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Perugia, 06132, Italy
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Roma, 00144, Italy
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Rozzano, 20089, Italy
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México, 14080, Mexico
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Morelia, 58000, Mexico
Research Site
Zacatecas City, 98000, Mexico
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Lima, LIMA 11, Peru
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Lima, LIMA 27, Peru
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Lima, LIMA 33, Peru
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Lima, LIMA 41, Peru
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A Coruña, 15006, Spain
Research Site
Badalona(Barcelona), 08916, Spain
Research Site
Barcelona, 08028, Spain
Research Site
Madrid, 28041, Spain
Research Site
Málaga, 29010, Spain
Related Publications (2)
Janne PA, Smith I, McWalter G, Mann H, Dougherty B, Walker J, Orr MC, Hodgson DR, Shaw AT, Pereira JR, Jeannin G, Vansteenkiste J, Barrios CH, Franke FA, Crino L, Smith P. Impact of KRAS codon subtypes from a randomised phase II trial of selumetinib plus docetaxel in KRAS mutant advanced non-small-cell lung cancer. Br J Cancer. 2015 Jul 14;113(2):199-203. doi: 10.1038/bjc.2015.215. Epub 2015 Jun 30.
PMID: 26125448DERIVEDJanne PA, Shaw AT, Pereira JR, Jeannin G, Vansteenkiste J, Barrios C, Franke FA, Grinsted L, Zazulina V, Smith P, Smith I, Crino L. Selumetinib plus docetaxel for KRAS-mutant advanced non-small-cell lung cancer: a randomised, multicentre, placebo-controlled, phase 2 study. Lancet Oncol. 2013 Jan;14(1):38-47. doi: 10.1016/S1470-2045(12)70489-8. Epub 2012 Nov 28.
PMID: 23200175DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tracy Cunningham
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Pasi Janne
Dana-Farber Cancer Institute, Boston, USA
- STUDY DIRECTOR
Dr. Gabriella Mariani
AstraZeneca, Hertfordshire, UK
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2009
First Posted
April 30, 2009
Study Start
April 20, 2009
Primary Completion
May 11, 2011
Study Completion
November 2, 2016
Last Updated
June 20, 2018
Results First Posted
June 20, 2018
Record last verified: 2018-05