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Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00936221
First received: July 8, 2009
Last updated: February 11, 2016
Last verified: February 2016
Results First Received: November 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Melanoma
Interventions: Drug: AZD6244
Drug: Dacarbazine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Selumetinib 75mg BD +Dacarbazine selumetinib 75mg twice daily + Dacarbazine
Placebo BD + Dacarbazine Placebo twice daily + Dacarbazine

Participant Flow:   Overall Study
    Selumetinib 75mg BD +Dacarbazine   Placebo BD + Dacarbazine
STARTED   45   46 
Received Treatment   44   45 
COMPLETED   44 [1]   45 [2] 
NOT COMPLETED   1   1 
Withdrawal by Subject                1                1 
[1] 13 patients ongoing cutoff + 31 patients who had died.
[2] 10 patients ongoing at data cutoff + 35 patients who had died.



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Selumetinib 75mg BD +Dacarbazine selumetinib 75mg twice daily + Dacarbazine
Placebo BD + Dacarbazine Placebo twice daily + Dacarbazine
Total Total of all reporting groups

Baseline Measures
   Selumetinib 75mg BD +Dacarbazine   Placebo BD + Dacarbazine   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   46   91 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.7  (14.89)   51.6  (16.21)   53.6  (15.62) 
Gender 
[Units: Participants]
     
Female   23   18   41 
Male   22   28   50 


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later ]

2.  Secondary:   Progression Free Survival   [ Time Frame: From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment ]

3.  Secondary:   Objective Response Rate   [ Time Frame: From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment ]

4.  Secondary:   Change in Target Lesion Tumour Size at Week 12   [ Time Frame: randomization to week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Gabriella Mariani
Organization: AstraZeneca
phone: +44 7818 523 899
e-mail: ClinicalTrialTransparency@astrazeneca.com


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00936221     History of Changes
Other Study ID Numbers: D1532C00006
Study First Received: July 8, 2009
Results First Received: November 4, 2015
Last Updated: February 11, 2016
Health Authority: United States: Food and Drug Administration