Trial Outcomes & Findings for MEK Inhibitor AZD6244 in Treating Patients With Stage III or Stage IV Melanoma (NCT NCT00866177)
NCT ID: NCT00866177
Last Updated: 2015-08-11
Results Overview
Anti-tumor response defined as either a Complete Response, Partial Response, or Stable Disease as defined by RECIST
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
167 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2015-08-11
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
167
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
152
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Not Treated
|
151
|
Baseline Characteristics
MEK Inhibitor AZD6244 in Treating Patients With Stage III or Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
AZD6244
n=167 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
107 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
167 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksAnti-tumor response defined as either a Complete Response, Partial Response, or Stable Disease as defined by RECIST
Outcome measures
| Measure |
AZD6244
n=15 Participants
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.
|
|---|---|
|
Anti-tumor Response Defined as Either a CR, PR, or SD as Defined by RECIST
Partial Response
|
1 participants
|
|
Anti-tumor Response Defined as Either a CR, PR, or SD as Defined by RECIST
Stable Disease
|
8 participants
|
|
Anti-tumor Response Defined as Either a CR, PR, or SD as Defined by RECIST
Progression of Disease
|
6 participants
|
Adverse Events
AZD6244
Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD6244
n=15 participants at risk
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.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
13.3%
2/15 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
2/15 • Number of events 2
|
|
Investigations
Alkaline phosphatase increased
|
6.7%
1/15 • Number of events 2
|
|
Investigations
Blood Bilirubin increase
|
6.7%
1/15 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Number of events 3
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 2
|
|
Cardiac disorders
Heart failure
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
13.3%
2/15 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Chest pain
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash, acne
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Right ventricular dysfunction
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Rigors/chills
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
Vascular disorder
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1
|
Other adverse events
| Measure |
AZD6244
n=15 participants at risk
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.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
60.0%
9/15 • Number of events 14
|
|
Investigations
Alkaline phosphatase increased
|
53.3%
8/15 • Number of events 24
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
10/15 • Number of events 30
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
53.3%
8/15 • Number of events 16
|
|
Investigations
Blood Bilirubin increased
|
33.3%
5/15 • Number of events 10
|
|
Cardiac disorders
Cardiac disorder
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
3/15 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.7%
4/15 • Number of events 5
|
|
General disorders
Edema-Limbs
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Fatigue
|
33.3%
5/15 • Number of events 6
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Heart failure
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.0%
6/15 • Number of events 22
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.3%
2/15 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
1/15 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.3%
2/15 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
26.7%
4/15 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
1/15 • Number of events 2
|
|
Investigations
INR increase
|
6.7%
1/15 • Number of events 3
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
13.3%
2/15 • Number of events 2
|
|
Investigations
Lymphocyte count decrease
|
20.0%
3/15 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2
|
|
Investigations
Neutrophil count decrease
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Platelet count decrease
|
20.0%
3/15 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
66.7%
10/15 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.3%
2/15 • Number of events 2
|
|
Cardiac disorders
Right ventricular dysfunction
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2
|
|
Investigations
White blood cell decrease
|
26.7%
4/15 • Number of events 6
|
Additional Information
Dr. Paul Chapman
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4162
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60