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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
Enrollment 167
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AZD6244
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 167
Completed 15
Not Completed 152
Reason Not Completed
Withdrawal by Subject             1
Not Treated             151
Arm/Group Title AZD6244
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 167
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants
<=18 years
0
   0.0%
Between 18 and 65 years
107
  64.1%
>=65 years
60
  35.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants
Female
51
  30.5%
Male
116
  69.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 167 participants
167
1.Primary Outcome
Title Anti-tumor Response Defined as Either a CR, PR, or SD as Defined by RECIST
Hide Description Anti-tumor response defined as either a Complete Response, Partial Response, or Stable Disease as defined by RECIST
Time Frame Up to 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD6244
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
Partial Response 1
Stable Disease 8
Progression of Disease 6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD6244
Hide Arm/Group Description 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.
All-Cause Mortality
AZD6244
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AZD6244
Affected / at Risk (%) # Events
Total   6/15 (40.00%)    
Cardiac disorders   
Heart failure  1  1/15 (6.67%)  1
Left ventricular systolic dysfunction  1  2/15 (13.33%)  2
Right ventricular dysfunction  1  1/15 (6.67%)  1
Gastrointestinal disorders   
Diarrhea  1  1/15 (6.67%)  1
Vomiting  1  1/15 (6.67%)  1
General disorders   
Fatigue  1  1/15 (6.67%)  1
Fever  1  1/15 (6.67%)  2
Chest pain  1  1/15 (6.67%)  1
Rigors/chills  1  1/15 (6.67%)  1
Investigations   
Alanine aminotransferase increased  1  2/15 (13.33%)  2
Aspartate aminotransferase increased  1  2/15 (13.33%)  2
Alkaline phosphatase increased  1  1/15 (6.67%)  2
Blood Bilirubin increase  1  1/15 (6.67%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  2/15 (13.33%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/15 (6.67%)  3
Pleural effusion  1  1/15 (6.67%)  1
Skin and subcutaneous tissue disorders   
Rash, acne  1  1/15 (6.67%)  1
Vascular disorders   
Thromboembolic event  1  1/15 (6.67%)  1
Vascular disorder  1  2/15 (13.33%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AZD6244
Affected / at Risk (%) # Events
Total   14/15 (93.33%)    
Blood and lymphatic system disorders   
Anemia  1  8/15 (53.33%)  16
Cardiac disorders   
Cardiac disorder  1  1/15 (6.67%)  1
Heart failure  1  1/15 (6.67%)  1
Left ventricular systolic dysfunction  1  2/15 (13.33%)  2
Right ventricular dysfunction  1  1/15 (6.67%)  1
Gastrointestinal disorders   
Constipation  1  1/15 (6.67%)  1
Diarrhea  1  3/15 (20.00%)  3
Nausea  1  2/15 (13.33%)  2
Vomiting  1  2/15 (13.33%)  2
General disorders   
Edema-Limbs  1  2/15 (13.33%)  2
Fatigue  1  5/15 (33.33%)  6
Fever  1  1/15 (6.67%)  1
Investigations   
Alanine aminotransferase increased  1  9/15 (60.00%)  14
Alkaline phosphatase increased  1  8/15 (53.33%)  24
Aspartate aminotransferase increased  1  10/15 (66.67%)  30
Blood Bilirubin increased  1  5/15 (33.33%)  10
INR increase  1  1/15 (6.67%)  3
Lymphocyte count decrease  1  3/15 (20.00%)  3
Neutrophil count decrease  1  1/15 (6.67%)  1
Platelet count decrease  1  3/15 (20.00%)  10
White blood cell decrease  1  4/15 (26.67%)  6
Metabolism and nutrition disorders   
Hyperglycemia  1  6/15 (40.00%)  22
Hyperkalemia  1  1/15 (6.67%)  1
Hypoalbuminemia  1  2/15 (13.33%)  6
Hypocalcemia  1  1/15 (6.67%)  2
Hypokalemia  1  2/15 (13.33%)  2
Hypomagnesemia  1  4/15 (26.67%)  10
Hypophosphatemia  1  1/15 (6.67%)  2
Musculoskeletal and connective tissue disorders   
Chest wall pain  1  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  4/15 (26.67%)  5
Pleural effusion  1  1/15 (6.67%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  1/15 (6.67%)  1
Rash acneiform  1  10/15 (66.67%)  12
Rash maculo-papular  1  2/15 (13.33%)  2
Skin ulceration  1  1/15 (6.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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.
Results Point of Contact
Name/Title: Dr. Paul Chapman
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4162
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