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AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive NSCLC Patients

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ClinicalTrials.gov Identifier: NCT00890825
Recruitment Status : Completed
First Posted : April 30, 2009
Results First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Non Small Cell Lung Cancer
Interventions: Drug: AZD6244
Drug: docetaxel
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Selection of patients was in 2nd line patients with KRAS mutation positive locally advanced or metastatic NSCLC (Stage IIIB – IV).First patient enrolled: 20 April 2009.Last patient last visit: 30 June 2010.Data Cut Off (DCO): 01 May 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AZD6244 + Docetaxel AZD6244 75 mg bd + Docetaxel 75 mg/m^2
Placebo + Docetaxel Placebo + Docetaxel 75 mg/m^2

Participant Flow:   Overall Study
    AZD6244 + Docetaxel   Placebo + Docetaxel
STARTED   44   43 [1] 
COMPLETED   30   29 
NOT COMPLETED   14   14 
Withdrawal by Subject                1                0 
Alive at data cut off (DCO)                13                14 
[1] A patient randomized to this arm was excluded from the safety population for not receiving treatment



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat (ITT) analysis set

Reporting Groups
  Description
AZD6244 + Docetaxel AZD6244 75 mg bd + Docetaxel 75 mg/m^2
Placebo + Docetaxel Placebo + Docetaxel 75 mg/m^2
Total Total of all reporting groups

Baseline Measures
   AZD6244 + Docetaxel   Placebo + Docetaxel   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   43   87 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.2  (9.22)   58.6  (8.38)   58.4  (8.77) 
Age, Customized 
[Units: Participants]
Count of Participants
     
Age group : <=55 years   15   15   30 
Age group : >55 years   29   28   57 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      23  52.3%      23  53.5%      46  52.9% 
Male      21  47.7%      20  46.5%      41  47.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White      41  93.2%      40  93.0%      81  93.1% 
Black or African American      1   2.3%      1   2.3%      2   2.3% 
Other      2   4.5%      2   4.7%      4   4.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Hispanic or Latino   7   10   17 
Not Hispanic or Latino   37   33   70 


  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: At least 12 months since start of treatment. ]

2.  Secondary:   Progression Free Survival   [ Time Frame: At least 12 months after start of treatment ]

3.  Secondary:   Objective Response Rate   [ Time Frame: At least 12 months after start of treatment ]

4.  Secondary:   Duration of Response   [ Time Frame: At least 12 months after start of treatment ]

5.  Secondary:   Change From Baseline in Tumour Size at 6 Week.   [ Time Frame: 6 weeks after first dose of treatment ]

6.  Secondary:   Change From Baseline in Tumour Size at Week 12   [ Time Frame: 12 weeks ]

7.  Secondary:   Alive and Progression-Free at 6 Months   [ Time Frame: 6 months after first dose of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Tracy Cunningham
Organization: AstraZeneca
phone: 1-877-400-4656
e-mail: clinicaltrialtransparency@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00890825     History of Changes
Other Study ID Numbers: D1532C00016
First Submitted: April 29, 2009
First Posted: April 30, 2009
Results First Submitted: June 14, 2017
Results First Posted: June 20, 2018
Last Update Posted: June 20, 2018