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MEK Inhibitor AZD6244 in Treating Patients With Stage III or Stage IV Melanoma

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ClinicalTrials.gov Identifier: NCT00866177
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : August 11, 2015
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Recurrent Melanoma
Stage III Skin Melanoma
Stage IV Skin Melanoma
Interventions: Other: Laboratory Biomarker Analysis
Drug: Selumetinib

  Participant Flow

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
AZD6244 Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    AZD6244
STARTED   167 
COMPLETED   15 
NOT COMPLETED   152 
Withdrawal by Subject                1 
Not Treated                151 



  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.
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Reporting Groups
  Description
AZD6244 Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   AZD6244 
Overall Participants Analyzed 
[Units: Participants]
 167 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   107 
>=65 years   60 
Gender 
[Units: Participants]
 
Female   51 
Male   116 
Region of Enrollment 
[Units: Participants]
 
United States   167 


  Outcome Measures

1.  Primary:   Anti-tumor Response Defined as Either a CR, PR, or SD as Defined by RECIST   [ Time Frame: Up to 4 weeks ]


  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
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  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: Dr. Paul Chapman
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4162
e-mail: chapmanp@mskcc.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00866177     History of Changes
Other Study ID Numbers: NCI-2009-01164
NCI-2009-01164 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MSKCC-09003
CDR0000637669
09-003 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
8252 ( Other Identifier: CTEP )
N01CM62206 ( U.S. NIH Grant/Contract )
P30CA008748 ( U.S. NIH Grant/Contract )
First Submitted: March 19, 2009
First Posted: March 20, 2009
Results First Submitted: July 16, 2015
Results First Posted: August 11, 2015
Last Update Posted: August 11, 2015